<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03775915</url>
  </required_header>
  <id_info>
    <org_study_id>StrokeNF</org_study_id>
    <nct_id>NCT03775915</nct_id>
  </id_info>
  <brief_title>Neurofeedback for Stroke Rehabilitation</brief_title>
  <official_title>The Use of Real-Time fMRI and a Mobile EEG System to Provide Neurofeedback to Stroke Patients to Promote Neural Plasticity for Motor Rehabilitation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wellcome Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oxford</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Real-time neurofeedback aims to alter brain activation patterns through online feedback of&#xD;
      ongoing brain activity using magnetic resonance imagining (MRI). Stroke survivors will be&#xD;
      randomised to receive 3 sessions of real or sham neurofeedback. This study aims to&#xD;
      investigate whether: 1) stroke survivors can maintain alterations in brain activity after the&#xD;
      feedback is removed, 2) neurofeedback training leads to improvements in movement of the hand&#xD;
      and arm, 3) neurofeedback training leads to changes in brain structure and function, 4)&#xD;
      variability in response across people can be understood.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many stroke survivors experience impairment in upper limb function, reducing independence in&#xD;
      activities of daily living. These impairments are associated with atypical brain activity&#xD;
      patterns. Real-time neurofeedback aims to alter brain activation patterns through online&#xD;
      feedback of ongoing brain activity using magnetic resonance imagining (MRI). Patterns of&#xD;
      brain activity are displayed to a participant while a task is being performed. The&#xD;
      participant is instructed to try to alter the patterns in a particular way, promoting&#xD;
      specific brain activity patterns. Previous studies have found that people with and without&#xD;
      stroke are capable of utilising the feedback to alter their brain activity. This study aims&#xD;
      to investigate whether:&#xD;
&#xD;
        1. stroke survivors can maintain alterations in brain activity after the feedback is&#xD;
           removed&#xD;
&#xD;
        2. neurofeedback training leads to improvements in movement of the hand and arm&#xD;
&#xD;
        3. neurofeedback training leads to changes in brain structure and function&#xD;
&#xD;
        4. variability in response across people can be understood.&#xD;
&#xD;
      30 stroke survivors (&gt; 6 months after stroke), with residual upper limb impairment, will be&#xD;
      recruited between February 2018 and December 2020. Participants will be randomised to receive&#xD;
      3 sessions of real or sham neurofeedback over one week, taking place at the Wellcome Centre&#xD;
      for Integrative Neuroimaging, University of Oxford. Changes in brain activity during affected&#xD;
      hand movements will be assessed with and without feedback using functional MRI and after&#xD;
      feedback sessions using electroencephalography (EEG). Brain connectivity and structure will&#xD;
      also be assessed using MRI at baseline and at a follow-up one week later. Clinical measures&#xD;
      of upper limb function and impairment will be performed at baseline and at follow up sessions&#xD;
      one week and one month later (Action Research Arm Test, Fugl-Meyer upper limb assessment,&#xD;
      Jebsen Taylor hand function test), and in each session following neurofeedback (Jebsen taylor&#xD;
      test).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID-19 lockdown and halt of clinical trials&#xD;
  </why_stopped>
  <start_date type="Actual">February 9, 2018</start_date>
  <completion_date type="Actual">March 20, 2020</completion_date>
  <primary_completion_date type="Actual">March 20, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants are randomly allocated (1:1 ratio) to either the intervention group (Real Neurofeedback) or the control group (Sham Neurofeedback). Randomisation is done after participants undergo baseline measurements using a computer-generated minimisation method that takes into account baseline upper limb function (Action Research Arm test score) and time since stroke.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lateralisation of Brain Activity</measure>
    <time_frame>Throughout the 3 intervention sessions, an average of 4 days</time_frame>
    <description>Lateralisation of brain activity during movement of the affected hand, assessed using functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) signal. The activation in the region of interest is calculated for each hemisphere and the laterality index calculated as: (ipsilesional hemisphere - contralesional hemisphere) / (ipsilesional hemisphere + contralesional hemisphere). As such, positive values are indicative of greater activation in the ipsilesional hemisphere.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hand Function Assessed With the Jebsen Taylor Hand Function Test (Time, in Seconds)</measure>
    <time_frame>Throughout study completion, 5 assessment sessions spread over approximately 3 weeks</time_frame>
    <description>Performance on the Jebsen Taylor hand function test (time, in seconds to complete specified activities reflecting daily living)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Lateralisation of Brain Activity</measure>
    <time_frame>1 week follow up</time_frame>
    <description>Change in lateralisation of brain activity during movement of the affected hand, assessed using functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) signal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lateralisation of Brain Activity During Visuomotor Squeeze Task (MRI)</measure>
    <time_frame>Baseline, 1 week follow up</time_frame>
    <description>Lateralisation of brain activity during a visuomotor squeeze task, assessed using functional magnetic resonance imaging (BOLD signal). The activation in the region of interest is calculated for each hemisphere and the laterality index calculated as: (ipsilesional hemisphere - contralesional hemisphere) / (ipsilesional hemisphere + contralesional hemisphere). As such, positive values are indicative of greater activation in the ipsilesional hemisphere.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lateralisation of Brain Activity During Visuomotor Squeeze Task (EEG)</measure>
    <time_frame>Throughout study completion, an average of 3 weeks</time_frame>
    <description>Change in lateralisation of brain activity during a visuomotor squeeze task, assessed using EEG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper Limb Function</measure>
    <time_frame>Baseline, 1 week follow up</time_frame>
    <description>Action research arm test score (ARAT; upper limb function). Range 0-57, higher numbers indicate better upper limb function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Upper Limb Function</measure>
    <time_frame>1 month follow up</time_frame>
    <description>Change in action research arm test score (ARAT; upper limb function). Range 0-57, higher numbers indicate better upper limb function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper Limb Impairment</measure>
    <time_frame>Baseline, 1 week follow up</time_frame>
    <description>Upper limb Fugl Meyer assessment score (upper limb impairment). Range 0-66, higher numbers indicate less upper limb impairment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper Limb Impairment</measure>
    <time_frame>Baseline, 1 month follow up</time_frame>
    <description>Upper limb Fugl Meyer assessment score (upper limb impairment). Range 0-66, higher numbers indicate less upper limb impairment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Resting State Functional Connectivity</measure>
    <time_frame>1 week follow up</time_frame>
    <description>Change in resting state functional connectivity, assessed using fMRI Analysis still in progress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in White Matter Tract Integrity</measure>
    <time_frame>1 week follow up</time_frame>
    <description>Change in integrity of the white matter tracts, assessed using diffusion tensor imaging Analysis nearly completed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Grey Matter Volume</measure>
    <time_frame>Baseline, 1 week follow up</time_frame>
    <description>Change in grey matter volume derived from structural (T1) MRI Analysis still in progress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in White Matter Microstructure</measure>
    <time_frame>1 week follow up</time_frame>
    <description>Change in white matter microstructure, specifically myelin content, assessed using MRI Multi-Parameter Mapping</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Baseline Structure and Function as a Correlate of Response to Neurofeedback</measure>
    <time_frame>Throughout study completion, an average of 3 weeks.</time_frame>
    <description>The correlation between baseline measures and change in lateralisation of brain activity during movement of the affected hand will be tested in order to identify markers to explain variability in response to real neurofeedback.&#xD;
Analysis still in progress</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Real Neurofeedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 sessions of Real Neurofeedback over 1 week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Neurofeedback</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>3 sessions of Sham Neurofeedback over 1 week</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neurofeedback</intervention_name>
    <description>A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.</description>
    <arm_group_label>Real Neurofeedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham Neurofeedback</intervention_name>
    <description>A visual representation of brain activity pre-recorded from a previous participant</description>
    <arm_group_label>Sham Neurofeedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stroke &gt; 6 months previously&#xD;
&#xD;
          -  Unilateral upper limb impairment, but physically able to complete the tasks required&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to MRI, such as a pacemaker, metallic implants or aneurysm clips&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Inability to actively participate in the research procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heidi Johansen-Berg, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oxford</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wellcome Centre for Integrative Neuroimaging (WIN)</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <results_first_submitted>June 11, 2021</results_first_submitted>
  <results_first_submitted_qc>July 19, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 13, 2021</results_first_posted>
  <last_update_submitted>May 16, 2023</last_update_submitted>
  <last_update_submitted_qc>May 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Motor function</keyword>
  <keyword>Brain activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymous data may be shared with other researchers on request</ipd_description>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Analysis code may be shared following publication of the study results. There is no set end date for this</ipd_time_frame>
    <ipd_access_criteria>Upon reasonable request to the PI</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 10, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03775915/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from the community, between February 2018 and March 2020</recruitment_details>
      <pre_assignment_details>3 participants were not randomised to a group. 1 was withdrawn because the location of their stroke lesion made it impossible to deliver the intervention. 1 withdrew because they did not like the MRI scan. 1 was unable to continue due to study suspension because of the coronavirus pandemic.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Real Neurofeedback</title>
          <description>3 sessions of Real Neurofeedback over 1 week&#xD;
Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.</description>
        </group>
        <group group_id="P2">
          <title>Sham Neurofeedback</title>
          <description>3 sessions of Sham Neurofeedback over 1 week&#xD;
Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Real Neurofeedback</title>
          <description>3 sessions of Real Neurofeedback over 1 week&#xD;
Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.</description>
        </group>
        <group group_id="B2">
          <title>Sham Neurofeedback</title>
          <description>3 sessions of Sham Neurofeedback over 1 week&#xD;
Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="24"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64" spread="11"/>
                    <measurement group_id="B2" value="59" spread="13"/>
                    <measurement group_id="B3" value="62" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Affected Hand</title>
          <description>Right, Left</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Right</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Left</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time since stroke</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79" spread="70"/>
                    <measurement group_id="B2" value="72" spread="63"/>
                    <measurement group_id="B3" value="76" spread="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Lateralisation of Brain Activity</title>
        <description>Lateralisation of brain activity during movement of the affected hand, assessed using functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) signal. The activation in the region of interest is calculated for each hemisphere and the laterality index calculated as: (ipsilesional hemisphere - contralesional hemisphere) / (ipsilesional hemisphere + contralesional hemisphere). As such, positive values are indicative of greater activation in the ipsilesional hemisphere.</description>
        <time_frame>Throughout the 3 intervention sessions, an average of 4 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Real Neurofeedback</title>
            <description>3 sessions of Real Neurofeedback over 1 week&#xD;
Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.</description>
          </group>
          <group group_id="O2">
            <title>Sham Neurofeedback</title>
            <description>3 sessions of Sham Neurofeedback over 1 week&#xD;
Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant</description>
          </group>
        </group_list>
        <measure>
          <title>Lateralisation of Brain Activity</title>
          <description>Lateralisation of brain activity during movement of the affected hand, assessed using functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) signal. The activation in the region of interest is calculated for each hemisphere and the laterality index calculated as: (ipsilesional hemisphere - contralesional hemisphere) / (ipsilesional hemisphere + contralesional hemisphere). As such, positive values are indicative of greater activation in the ipsilesional hemisphere.</description>
          <units>laterality index adjusted for baseline</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.23" lower_limit="0.15" upper_limit="0.31"/>
                    <measurement group_id="O2" value="0.30" lower_limit="0.22" upper_limit="0.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26" lower_limit="0.17" upper_limit="0.34"/>
                    <measurement group_id="O2" value="0.22" lower_limit="0.13" upper_limit="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25" lower_limit="0.17" upper_limit="0.34"/>
                    <measurement group_id="O2" value="0.25" lower_limit="0.16" upper_limit="0.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <p_value_desc>p-value calculated for interaction between group and day</p_value_desc>
            <method>Linear Mixed Model</method>
            <method_desc>Linear mixed effects model adjusted for baseline, F(2,46) = 1.061, p &gt;0.05</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hand Function Assessed With the Jebsen Taylor Hand Function Test (Time, in Seconds)</title>
        <description>Performance on the Jebsen Taylor hand function test (time, in seconds to complete specified activities reflecting daily living)</description>
        <time_frame>Throughout study completion, 5 assessment sessions spread over approximately 3 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Real Neurofeedback</title>
            <description>3 sessions of Real Neurofeedback over 1 week&#xD;
Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.</description>
          </group>
          <group group_id="O2">
            <title>Sham Neurofeedback</title>
            <description>3 sessions of Sham Neurofeedback over 1 week&#xD;
Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant</description>
          </group>
        </group_list>
        <measure>
          <title>Hand Function Assessed With the Jebsen Taylor Hand Function Test (Time, in Seconds)</title>
          <description>Performance on the Jebsen Taylor hand function test (time, in seconds to complete specified activities reflecting daily living)</description>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="267" spread="73"/>
                    <measurement group_id="O2" value="274" spread="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="238" spread="64"/>
                    <measurement group_id="O2" value="270" spread="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="221" spread="59"/>
                    <measurement group_id="O2" value="267" spread="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="220" spread="61"/>
                    <measurement group_id="O2" value="233" spread="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="214" spread="61"/>
                    <measurement group_id="O2" value="249" spread="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Lateralisation of Brain Activity</title>
        <description>Change in lateralisation of brain activity during movement of the affected hand, assessed using functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) signal.</description>
        <time_frame>1 week follow up</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lateralisation of Brain Activity During Visuomotor Squeeze Task (MRI)</title>
        <description>Lateralisation of brain activity during a visuomotor squeeze task, assessed using functional magnetic resonance imaging (BOLD signal). The activation in the region of interest is calculated for each hemisphere and the laterality index calculated as: (ipsilesional hemisphere - contralesional hemisphere) / (ipsilesional hemisphere + contralesional hemisphere). As such, positive values are indicative of greater activation in the ipsilesional hemisphere.</description>
        <time_frame>Baseline, 1 week follow up</time_frame>
        <population>Outliers removed on the basis of head motion or laterality index greater than 2 standard deviations from the mean</population>
        <group_list>
          <group group_id="O1">
            <title>Real Neurofeedback</title>
            <description>3 sessions of Real Neurofeedback over 1 week&#xD;
Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.</description>
          </group>
          <group group_id="O2">
            <title>Sham Neurofeedback</title>
            <description>3 sessions of Sham Neurofeedback over 1 week&#xD;
Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant</description>
          </group>
        </group_list>
        <measure>
          <title>Lateralisation of Brain Activity During Visuomotor Squeeze Task (MRI)</title>
          <description>Lateralisation of brain activity during a visuomotor squeeze task, assessed using functional magnetic resonance imaging (BOLD signal). The activation in the region of interest is calculated for each hemisphere and the laterality index calculated as: (ipsilesional hemisphere - contralesional hemisphere) / (ipsilesional hemisphere + contralesional hemisphere). As such, positive values are indicative of greater activation in the ipsilesional hemisphere.</description>
          <population>Outliers removed on the basis of head motion or laterality index greater than 2 standard deviations from the mean</population>
          <units>laterality index</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.31" spread="0.03"/>
                    <measurement group_id="O2" value="0.21" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 week follow up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.29" spread="0.03"/>
                    <measurement group_id="O2" value="0.28" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lateralisation of Brain Activity During Visuomotor Squeeze Task (EEG)</title>
        <description>Change in lateralisation of brain activity during a visuomotor squeeze task, assessed using EEG</description>
        <time_frame>Throughout study completion, an average of 3 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Upper Limb Function</title>
        <description>Action research arm test score (ARAT; upper limb function). Range 0-57, higher numbers indicate better upper limb function</description>
        <time_frame>Baseline, 1 week follow up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Real Neurofeedback</title>
            <description>3 sessions of Real Neurofeedback over 1 week&#xD;
Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.</description>
          </group>
          <group group_id="O2">
            <title>Sham Neurofeedback</title>
            <description>3 sessions of Sham Neurofeedback over 1 week&#xD;
Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant</description>
          </group>
        </group_list>
        <measure>
          <title>Upper Limb Function</title>
          <description>Action research arm test score (ARAT; upper limb function). Range 0-57, higher numbers indicate better upper limb function</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.9" spread="3.5"/>
                    <measurement group_id="O2" value="35.3" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 week follow up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.3" spread="3.7"/>
                    <measurement group_id="O2" value="35.8" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Upper Limb Function</title>
        <description>Change in action research arm test score (ARAT; upper limb function). Range 0-57, higher numbers indicate better upper limb function</description>
        <time_frame>1 month follow up</time_frame>
        <population>Only participants who were able to attend the 1 month follow up are included</population>
        <group_list>
          <group group_id="O1">
            <title>Real Neurofeedback</title>
            <description>3 sessions of Real Neurofeedback over 1 week&#xD;
Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.</description>
          </group>
          <group group_id="O2">
            <title>Sham Neurofeedback</title>
            <description>3 sessions of Sham Neurofeedback over 1 week&#xD;
Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Upper Limb Function</title>
          <description>Change in action research arm test score (ARAT; upper limb function). Range 0-57, higher numbers indicate better upper limb function</description>
          <population>Only participants who were able to attend the 1 month follow up are included</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.7" spread="5.5"/>
                    <measurement group_id="O2" value="38.3" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month follow up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.7" spread="5.7"/>
                    <measurement group_id="O2" value="38.5" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Upper Limb Impairment</title>
        <description>Upper limb Fugl Meyer assessment score (upper limb impairment). Range 0-66, higher numbers indicate less upper limb impairment</description>
        <time_frame>Baseline, 1 week follow up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Real Neurofeedback</title>
            <description>3 sessions of Real Neurofeedback over 1 week&#xD;
Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.</description>
          </group>
          <group group_id="O2">
            <title>Sham Neurofeedback</title>
            <description>3 sessions of Sham Neurofeedback over 1 week&#xD;
Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant</description>
          </group>
        </group_list>
        <measure>
          <title>Upper Limb Impairment</title>
          <description>Upper limb Fugl Meyer assessment score (upper limb impairment). Range 0-66, higher numbers indicate less upper limb impairment</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.2" spread="2.9"/>
                    <measurement group_id="O2" value="44.3" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 week follow up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.8" spread="2.2"/>
                    <measurement group_id="O2" value="46.3" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Upper Limb Impairment</title>
        <description>Upper limb Fugl Meyer assessment score (upper limb impairment). Range 0-66, higher numbers indicate less upper limb impairment</description>
        <time_frame>Baseline, 1 month follow up</time_frame>
        <population>Only participants who were able to attend the 1 month follow up are included</population>
        <group_list>
          <group group_id="O1">
            <title>Real Neurofeedback</title>
            <description>3 sessions of Real Neurofeedback over 1 week&#xD;
Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.</description>
          </group>
          <group group_id="O2">
            <title>Sham Neurofeedback</title>
            <description>3 sessions of Sham Neurofeedback over 1 week&#xD;
Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant</description>
          </group>
        </group_list>
        <measure>
          <title>Upper Limb Impairment</title>
          <description>Upper limb Fugl Meyer assessment score (upper limb impairment). Range 0-66, higher numbers indicate less upper limb impairment</description>
          <population>Only participants who were able to attend the 1 month follow up are included</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.7" spread="3.9"/>
                    <measurement group_id="O2" value="46.2" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month follow up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.6" spread="3.9"/>
                    <measurement group_id="O2" value="47.7" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Resting State Functional Connectivity</title>
        <description>Change in resting state functional connectivity, assessed using fMRI Analysis still in progress</description>
        <time_frame>1 week follow up</time_frame>
        <posting_date>07/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in White Matter Tract Integrity</title>
        <description>Change in integrity of the white matter tracts, assessed using diffusion tensor imaging Analysis nearly completed</description>
        <time_frame>1 week follow up</time_frame>
        <posting_date>07/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Grey Matter Volume</title>
        <description>Change in grey matter volume derived from structural (T1) MRI Analysis still in progress</description>
        <time_frame>Baseline, 1 week follow up</time_frame>
        <posting_date>07/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in White Matter Microstructure</title>
        <description>Change in white matter microstructure, specifically myelin content, assessed using MRI Multi-Parameter Mapping</description>
        <time_frame>1 week follow up</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Baseline Structure and Function as a Correlate of Response to Neurofeedback</title>
        <description>The correlation between baseline measures and change in lateralisation of brain activity during movement of the affected hand will be tested in order to identify markers to explain variability in response to real neurofeedback.&#xD;
Analysis still in progress</description>
        <time_frame>Throughout study completion, an average of 3 weeks.</time_frame>
        <posting_date>07/2024</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Real Neurofeedback</title>
          <description>3 sessions of Real Neurofeedback over 1 week&#xD;
Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.</description>
        </group>
        <group group_id="E2">
          <title>Sham Neurofeedback</title>
          <description>3 sessions of Sham Neurofeedback over 1 week&#xD;
Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Early termination due to COVID leading to smaller numbers enrolled in the study than originally planned. Interim analysis at the stopping point revealed results that were deemed unlikely to change with additional participants and so the study was closed and full analysis is in progress.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr Melanie Fleming, Research Associate</name_or_title>
      <organization>University of Oxford</organization>
      <phone>+441865611461</phone>
      <email>melanie.fleming@ndcn.ox.ac.uk</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03775915
org study id: StrokeNF
nct id: NCT03775915
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Real-time neurofeedback aims to alter brain activation patterns through online feedback of
      ongoing brain activity using magnetic resonance imagining (MRI). Stroke survivors will be
      randomised to receive 3 sessions of real or sham neurofeedback. This study aims to
      investigate whether: 1) stroke survivors can maintain alterations in brain activity after the
      feedback is removed, 2) neurofeedback training leads to improvements in movement of the hand
      and arm, 3) neurofeedback training leads to changes in brain structure and function, 4)
      variability in response across people can be understood.
Many stroke survivors experience impairment in upper limb function, reducing independence in
      activities of daily living. These impairments are associated with atypical brain activity
      patterns. Real-time neurofeedback aims to alter brain activation patterns through online
      feedback of ongoing brain activity using magnetic resonance imagining (MRI). Patterns of
      brain activity are displayed to a participant while a task is being performed. The
      participant is instructed to try to alter the patterns in a particular way, promoting
      specific brain activity patterns. Previous studies have found that people with and without
      stroke are capable of utilising the feedback to alter their brain activity. This study aims
      to investigate whether:

        1. stroke survivors can maintain alterations in brain activity after the feedback is
           removed

        2. neurofeedback training leads to improvements in movement of the hand and arm

        3. neurofeedback training leads to changes in brain structure and function

        4. variability in response across people can be understood.

      30 stroke survivors (> 6 months after stroke), with residual upper limb impairment, will be
      recruited between February 2018 and December 2020. Participants will be randomised to receive
      3 sessions of real or sham neurofeedback over one week, taking place at the Wellcome Centre
      for Integrative Neuroimaging, University of Oxford. Changes in brain activity during affected
      hand movements will be assessed with and without feedback using functional MRI and after
      feedback sessions using electroencephalography (EEG). Brain connectivity and structure will
      also be assessed using MRI at baseline and at a follow-up one week later. Clinical measures
      of upper limb function and impairment will be performed at baseline and at follow up sessions
      one week and one month later (Action Research Arm Test, Fugl-Meyer upper limb assessment,
      Jebsen Taylor hand function test), and in each session following neurofeedback (Jebsen taylor
      test).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are randomly allocated (1:1 ratio) to either the intervention group (Real Neurofeedback) or the control group (Sham Neurofeedback). Randomisation is done after participants undergo baseline measurements using a computer-generated minimisation method that takes into account baseline upper limb function (Action Research Arm test score) and time since stroke.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Lateralisation of Brain Activity
time frame: Throughout the 3 intervention sessions, an average of 4 days
description: Lateralisation of brain activity during movement of the affected hand, assessed using functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) signal. The activation in the region of interest is calculated for each hemisphere and the laterality index calculated as: (ipsilesional hemisphere - contralesional hemisphere) / (ipsilesional hemisphere + contralesional hemisphere). As such, positive values are indicative of greater activation in the ipsilesional hemisphere.
measure: Hand Function Assessed With the Jebsen Taylor Hand Function Test (Time, in Seconds)
time frame: Throughout study completion, 5 assessment sessions spread over approximately 3 weeks
description: Performance on the Jebsen Taylor hand function test (time, in seconds to complete specified activities reflecting daily living)
measure: Change in Lateralisation of Brain Activity
time frame: 1 week follow up
description: Change in lateralisation of brain activity during movement of the affected hand, assessed using functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) signal.
measure: Lateralisation of Brain Activity During Visuomotor Squeeze Task (MRI)
time frame: Baseline, 1 week follow up
description: Lateralisation of brain activity during a visuomotor squeeze task, assessed using functional magnetic resonance imaging (BOLD signal). The activation in the region of interest is calculated for each hemisphere and the laterality index calculated as: (ipsilesional hemisphere - contralesional hemisphere) / (ipsilesional hemisphere + contralesional hemisphere). As such, positive values are indicative of greater activation in the ipsilesional hemisphere.
measure: Lateralisation of Brain Activity During Visuomotor Squeeze Task (EEG)
time frame: Throughout study completion, an average of 3 weeks
description: Change in lateralisation of brain activity during a visuomotor squeeze task, assessed using EEG
measure: Upper Limb Function
time frame: Baseline, 1 week follow up
description: Action research arm test score (ARAT; upper limb function). Range 0-57, higher numbers indicate better upper limb function
measure: Change in Upper Limb Function
time frame: 1 month follow up
description: Change in action research arm test score (ARAT; upper limb function). Range 0-57, higher numbers indicate better upper limb function
measure: Upper Limb Impairment
time frame: Baseline, 1 week follow up
description: Upper limb Fugl Meyer assessment score (upper limb impairment). Range 0-66, higher numbers indicate less upper limb impairment
measure: Upper Limb Impairment
time frame: Baseline, 1 month follow up
description: Upper limb Fugl Meyer assessment score (upper limb impairment). Range 0-66, higher numbers indicate less upper limb impairment
measure: Change in Resting State Functional Connectivity
time frame: 1 week follow up
description: Change in resting state functional connectivity, assessed using fMRI Analysis still in progress
measure: Change in White Matter Tract Integrity
time frame: 1 week follow up
description: Change in integrity of the white matter tracts, assessed using diffusion tensor imaging Analysis nearly completed
measure: Change in Grey Matter Volume
time frame: Baseline, 1 week follow up
description: Change in grey matter volume derived from structural (T1) MRI Analysis still in progress
measure: Change in White Matter Microstructure
time frame: 1 week follow up
description: Change in white matter microstructure, specifically myelin content, assessed using MRI Multi-Parameter Mapping
measure: Baseline Structure and Function as a Correlate of Response to Neurofeedback
time frame: Throughout study completion, an average of 3 weeks.
description: The correlation between baseline measures and change in lateralisation of brain activity during movement of the affected hand will be tested in order to identify markers to explain variability in response to real neurofeedback.
Analysis still in progress
arm group label: Real Neurofeedback
arm group type: Experimental
description: 3 sessions of Real Neurofeedback over 1 week
arm group label: Sham Neurofeedback
arm group type: Sham Comparator
description: 3 sessions of Sham Neurofeedback over 1 week
intervention type: Other
intervention name: Neurofeedback
description: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.
arm group label: Real Neurofeedback
intervention type: Other
intervention name: Sham Neurofeedback
description: A visual representation of brain activity pre-recorded from a previous participant
arm group label: Sham Neurofeedback
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Heidi Johansen-Berg, PhD
role: Principal Investigator
affiliation: University of Oxford
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: Yes
ipd description: Anonymous data may be shared with other researchers on request
ipd info type: Analytic Code
ipd time frame: Analysis code may be shared following publication of the study results. There is no set end date for this
ipd access criteria: Upon reasonable request to the PI
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination due to COVID leading to smaller numbers enrolled in the study than originally planned. Interim analysis at the stopping point revealed results that were deemed unlikely to change with additional participants and so the study was closed and full analysis is in progress.
point of contact: 