<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/NCT03766113</url>
  </required_header>
  <id_info>
    <org_study_id>35RC18_9813_NeuroFB-AVC</org_study_id>
    <nct_id>NCT03766113</nct_id>
  </id_info>
  <brief_title>Neurofeedback for Upper-limb Recovery After Stroke</brief_title>
  <acronym>NeuroFB-AVC</acronym>
  <official_title>Effect of Unimodal (EEG) and Bimodal (EEG-fMRI) Neurofeedback on Upper Limb Recovery After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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>
      Interventional study with minimal risks and constraints, prospective, monocentric.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neurofeedback (NF) consists on training self-regulation of brain activity by providing&#xD;
      real-time information about the participant brain function NF approaches in stroke are&#xD;
      usually based on real-time monitoring of brain activity using EEG-NF and involve chronic&#xD;
      stroke. Recent studies have revealed the potential of combining EEG and fMRI to achieve a&#xD;
      more efficient and specific self-regulation, which may be critical in clinical applications.&#xD;
&#xD;
      The aim of this study is to optimize the neurofeedback method coupling EEG and fMRI in&#xD;
      healthy subjects then to evaluate the effect of an EEG-NF and a neurofeedback coupling EEG&#xD;
      and fMRI versus motor imagery on recovery in the early and chronic stage after stroke.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment difficulties&#xD;
  </why_stopped>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Actual">July 28, 2022</completion_date>
  <primary_completion_date type="Actual">July 28, 2022</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>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CXa: Active range of motion at elbow and wirst (from Tardieu scale)</measure>
    <time_frame>Change in Cxa between baseline and the end of the study</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Healthy volunteer</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>50 subjects&#xD;
A single neurofeedback coupling electroencephalogram and functional MRI in time actual .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients at the early stage after stroke</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>30 subjects&#xD;
Effectiveness of an electroencephalogram-neurofeedback</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients at the chronic stage after stroke</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>36 subjects&#xD;
Effectiveness of a neurofeedback coupling electroencephalogram and functional MRI in time actual</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neurofeedback coupling electroencephalogram and functional MRI in time actual</intervention_name>
    <description>One visit : Neurofeedback coupling electroencephalogram and functional MRI in time actual</description>
    <arm_group_label>Healthy volunteer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electroencephalogram-neurofeedback program or Neurofeedback-free mental imaging program with electroencephalogram recording</intervention_name>
    <description>Interventional group (Electroencephalogram-neurofeedback program) : 24 minutes, 3 times a week for 12 weeks in addition to the traditional rehabilitation program.&#xD;
Controle Group (Neurofeedback-free mental imaging) : 24 minutes, 3 times a week for 12 weeks in addition to the traditional rehabilitation program of reference.</description>
    <arm_group_label>Patients at the early stage after stroke</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neurofeedback coupling electroencephalogram and functional MRI in time actual or a neurofeedback-free mental imaging program with electroencephalogram recording</intervention_name>
    <description>Interventional group (5 weeks) : 5 sessions of neurofeedback coupling electroencephalogram and functional MRI in time actual and 9 sessions of electroencephalogram-neurofeedback program&#xD;
Controle Group (5 weeks) : 14 sessions of neurofeedback-free mental imaging program</description>
    <arm_group_label>Patients at the chronic stage after stroke</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients at the early stage after stroke : Ischemic or hemorrhagic unilateral stroke ;&#xD;
             adult (age greater than or equal to 18 years) under 80, of both sexes ; stroke less&#xD;
             than 1 month old ; upper limb deficit defined by a SAFE score &lt;8 (SAFE Stinear&#xD;
             protocol) at D3 of stroke; absence of comprehension difficulties limiting&#xD;
             participation ; with or without homonymous lateral hemianopia ; with or without&#xD;
             visuospatial henegligence ; free, informed and written consent signed by the patient&#xD;
             or a member of his entourage (in the case of a patient able to understand the&#xD;
             information and to express his / her consent but presenting motor difficulties leading&#xD;
             to an invalid signature).&#xD;
&#xD;
          -  Patients at the chronic stage after stroke : Ischemic or unilateral supra-tentorial&#xD;
             unilateral cerebral hemorrhage ; adult (age greater than or equal to 18 years) under&#xD;
             80, of both sexes ; stroke more than 6 months ; motor abilities of the upper limb&#xD;
             defines as &quot;poor&quot; to &quot;noticeable&quot; according to Hoonhorst on the Fugl-Meyer upper limb&#xD;
             scale, ranging between 22 and 53 out of 66 ; absence of comprehension difficulties&#xD;
             limiting participation ; with or without homonymous lateral hemianopia ; with or&#xD;
             without visuospatial henegligence ; free, informed and written consent signed by the&#xD;
             patient or a member of his entourage (in the case of a patient able to understand the&#xD;
             information and to express his / her consent but presenting motor difficulties leading&#xD;
             to an invalid signature).&#xD;
&#xD;
          -  Healthy Volunteers : Adult (age greater than or equal to 18 years) under 80, of both&#xD;
             sexes ; Free, informed and written consent signed by the volunteer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients at the early stage after stroke : Ischemic or haemorrhagic involvement of the&#xD;
             brainstem ; multiple stroke ; aphasia with major comprehension disorder ; major&#xD;
             persons subject to legal protection, persons deprived of their liberty.&#xD;
&#xD;
          -  Patients at the chronic stage after stroke : Ischemic or haemorrhagic involvement of&#xD;
             the brainstem ; multiple stroke ; aphasia with major comprehension disorder ; vascular&#xD;
             leukopathy important to MRI (Fazekas 3) in order not to interfere with the&#xD;
             interpretation of MRI ; contraindication to MRI ; major persons subject to legal&#xD;
             protection, persons deprived of their liberty.&#xD;
&#xD;
          -  Healthy Volunteers : Contraindication to MRI ; pregnancy ; breastfeeding ; major&#xD;
             persons subject to legal protection, persons deprived of their liberty&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Simon Butet</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rennes University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rennes University Hospital</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 8, 2022</last_update_submitted>
  <last_update_submitted_qc>December 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neurofeedback ; fMRI ; EEG ; BCI ; Motor imagery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03766113
org study id: 35RC18_9813_NeuroFB-AVC
nct id: NCT03766113
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Interventional study with minimal risks and constraints, prospective, monocentric.
Neurofeedback (NF) consists on training self-regulation of brain activity by providing
      real-time information about the participant brain function NF approaches in stroke are
      usually based on real-time monitoring of brain activity using EEG-NF and involve chronic
      stroke. Recent studies have revealed the potential of combining EEG and fMRI to achieve a
      more efficient and specific self-regulation, which may be critical in clinical applications.

      The aim of this study is to optimize the neurofeedback method coupling EEG and fMRI in
      healthy subjects then to evaluate the effect of an EEG-NF and a neurofeedback coupling EEG
      and fMRI versus motor imagery on recovery in the early and chronic stage after stroke.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Investigator)
measure: CXa: Active range of motion at elbow and wirst (from Tardieu scale)
time frame: Change in Cxa between baseline and the end of the study
arm group label: Healthy volunteer
arm group type: Other
description: 50 subjects
A single neurofeedback coupling electroencephalogram and functional MRI in time actual .
arm group label: Patients at the early stage after stroke
arm group type: Other
description: 30 subjects
Effectiveness of an electroencephalogram-neurofeedback
arm group label: Patients at the chronic stage after stroke
arm group type: Other
description: 36 subjects
Effectiveness of a neurofeedback coupling electroencephalogram and functional MRI in time actual
intervention type: Other
intervention name: Neurofeedback coupling electroencephalogram and functional MRI in time actual
description: One visit : Neurofeedback coupling electroencephalogram and functional MRI in time actual
arm group label: Healthy volunteer
intervention type: Other
intervention name: Electroencephalogram-neurofeedback program or Neurofeedback-free mental imaging program with electroencephalogram recording
description: Interventional group (Electroencephalogram-neurofeedback program) : 24 minutes, 3 times a week for 12 weeks in addition to the traditional rehabilitation program.
Controle Group (Neurofeedback-free mental imaging) : 24 minutes, 3 times a week for 12 weeks in addition to the traditional rehabilitation program of reference.
arm group label: Patients at the early stage after stroke
intervention type: Other
intervention name: Neurofeedback coupling electroencephalogram and functional MRI in time actual or a neurofeedback-free mental imaging program with electroencephalogram recording
description: Interventional group (5 weeks) : 5 sessions of neurofeedback coupling electroencephalogram and functional MRI in time actual and 9 sessions of electroencephalogram-neurofeedback program
Controle Group (5 weeks) : 14 sessions of neurofeedback-free mental imaging program
arm group label: Patients at the chronic stage after stroke
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Simon Butet
role: Principal Investigator
affiliation: Rennes University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Stroke