<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/NCT03257982</url>
  </required_header>
  <id_info>
    <org_study_id>GN17NE402</org_study_id>
    <nct_id>NCT03257982</nct_id>
  </id_info>
  <brief_title>Patient Self-managed BCI-FES</brief_title>
  <official_title>A Feasibility Study of Patient Self-Managed Brain-computer Interface Functional Electrical Stimulation (BCI-FES) Hand Therapy for Spinal Cord Injured Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NHS Greater Glasgow and Clyde</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Glasgow</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NHS Greater Glasgow and Clyde</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>
      This study aims to assess the feasibility of therapist-caregiver-patient training to use BCI&#xD;
      and FES technology with a view to the inexpensive equipment eventually being used for home&#xD;
      use by tetraplegic patients as a continuing rehabilitation method for sub-acute patients&#xD;
      discharged from hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation in the body.&#xD;
      People with injury around the neck, suffer from tetraplegia, which affects function of both&#xD;
      upper and lower limbs. Although these patients often have a caregiver, their main priority is&#xD;
      to regain some upper limb function to increase independence. About half of patients with&#xD;
      tetraplegia have an incomplete injury, i.e. have some sensation and control of muscles&#xD;
      preserved. Natural recovery takes about a year and is typically accompanied by intense&#xD;
      physical therapy while patients are in a hospital. Patients spend on average 4 months in&#xD;
      hospital and, once they go home, there are very limited options for further therapy, in&#xD;
      particular those living in rural areas.&#xD;
&#xD;
      This study will test the feasibility of patient and caregiver self-managed hand therapy based&#xD;
      on the combination of brain computer interface (BCI) and functional electrical stimulation&#xD;
      (FES). BCI is a system which consists of an electroencephalographic device (EEG), a computer&#xD;
      and software that can analyse EEG while it is being recorded. To ensure that the knowledge&#xD;
      stays within hospital, occupational therapists will first be trained who will then train&#xD;
      patients and caregivers. The BCI-FES therapy is based on a previous clinical study with&#xD;
      hospitalised patients, in which a researcher administered the therapy. In this study, a&#xD;
      portable BCI-FES system will be used with an inexpensive consumer BCI, which is designed for&#xD;
      non-professionals. The primary objective is to assess whether it is feasible for caregivers&#xD;
      and patients to learn to operate the portable BCI-FES system on their own within 5 training&#xD;
      sessions. The secondary objectives are to collect feedback from patients and therapists of&#xD;
      their views via semi-structured interviews and questionnaires; to assess how stable the&#xD;
      system parameters (EEG parameters, electrode location, FES stimulation parameters)are over&#xD;
      time; to assess whether there is any functional and neurological recovery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2018</start_date>
  <completion_date type="Actual">March 14, 2019</completion_date>
  <primary_completion_date type="Actual">March 14, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Successful training for operation of BCI-FES system</measure>
    <time_frame>2 months</time_frame>
    <description>Number of times patients/caregivers successfully operate BCI-FES system within 30 min</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>System reliability</measure>
    <time_frame>2 months</time_frame>
    <description>Number of times patients manage to activate the BCI-FES system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time taken to use system</measure>
    <time_frame>2 months</time_frame>
    <description>Average time required to accomplish BCI-FES therapy (excluding setup time)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NASA task load index</measure>
    <time_frame>2 months</time_frame>
    <description>Score from National Aeronautics and Space Administration (NASA) Task Load Index questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological Effect of Assistive Devices</measure>
    <time_frame>2 months</time_frame>
    <description>Score of Psychological Effect of Assistive Devices questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quebec User Evaluation of Satisfaction with Assistive Technology</measure>
    <time_frame>2 months</time_frame>
    <description>Score of Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grip strength</measure>
    <time_frame>Baseline and 2 months</time_frame>
    <description>Change in grip strength</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hand range of motion</measure>
    <time_frame>Baseline and 2 months</time_frame>
    <description>Change in hand range of motion</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>BCI-FES hand therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BCI-FES hand therapy sessions (set up and use of system)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>BCI-FES hand therapy</intervention_name>
    <description>BCI-FES rehabilitation therapy of the upper limb</description>
    <arm_group_label>BCI-FES hand therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients&#xD;
&#xD;
          -  being within a year post-injury&#xD;
&#xD;
          -  has a caregiver willing to commit their time to the study&#xD;
&#xD;
          -  normal or corrected to normal vision&#xD;
&#xD;
          -  no history of brain disease or injury&#xD;
&#xD;
          -  incomplete injury at level C2 to C7&#xD;
&#xD;
          -  minimum computer literacy&#xD;
&#xD;
          -  understands spoken and written English&#xD;
&#xD;
        Occupational therapists&#xD;
&#xD;
          -  already has experience in providing occupational therapy to spinal cord injured people&#xD;
&#xD;
          -  familiar with using FES on patients&#xD;
&#xD;
        Caregivers&#xD;
&#xD;
          -  able and willing to commit time to the study&#xD;
&#xD;
          -  minimum computer literacy&#xD;
&#xD;
          -  possess mobile phone with a camera or are allowed to use patient's mobile phone with a&#xD;
             camera for taking photos of the experimental setup (to remind themselves)&#xD;
&#xD;
          -  understands spoken and written English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients&#xD;
&#xD;
          -  presence of neurological problem which may distort brain signal recording (e.g.&#xD;
             epilepsy, Parkinson's disease, multiple sclerosis)&#xD;
&#xD;
          -  presence of cognitive impairments which would prevent patients or caregivers from&#xD;
             understanding the task&#xD;
&#xD;
          -  inability to sit for 2 hours&#xD;
&#xD;
          -  general poor health due to secondary consequences of injury&#xD;
&#xD;
          -  any condition that would be contraindicative of using FES (pacemakers, sensitive&#xD;
             skin/sores over areas where electrodes should be applied, pregnancy)&#xD;
&#xD;
        Occupational therapists&#xD;
&#xD;
          -  unable to commit sufficient time to the study&#xD;
&#xD;
          -  cannot learn to setup BCI-FES within 30 min within 4 hourly training sessions&#xD;
&#xD;
        Caregivers&#xD;
&#xD;
          -  cannot be present for all five therapy sessions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aleksandra Vuckovic, BEng MSc PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Glasgow</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Elizabeth National Spinal Injuries Unit</name>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>January 15, 2021</last_update_submitted>
  <last_update_submitted_qc>January 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Brain-computer interface</keyword>
  <keyword>Functional electrical stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03257982
org study id: GN17NE402
nct id: NCT03257982
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to assess the feasibility of therapist-caregiver-patient training to use BCI
      and FES technology with a view to the inexpensive equipment eventually being used for home
      use by tetraplegic patients as a continuing rehabilitation method for sub-acute patients
      discharged from hospital.
Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation in the body.
      People with injury around the neck, suffer from tetraplegia, which affects function of both
      upper and lower limbs. Although these patients often have a caregiver, their main priority is
      to regain some upper limb function to increase independence. About half of patients with
      tetraplegia have an incomplete injury, i.e. have some sensation and control of muscles
      preserved. Natural recovery takes about a year and is typically accompanied by intense
      physical therapy while patients are in a hospital. Patients spend on average 4 months in
      hospital and, once they go home, there are very limited options for further therapy, in
      particular those living in rural areas.

      This study will test the feasibility of patient and caregiver self-managed hand therapy based
      on the combination of brain computer interface (BCI) and functional electrical stimulation
      (FES). BCI is a system which consists of an electroencephalographic device (EEG), a computer
      and software that can analyse EEG while it is being recorded. To ensure that the knowledge
      stays within hospital, occupational therapists will first be trained who will then train
      patients and caregivers. The BCI-FES therapy is based on a previous clinical study with
      hospitalised patients, in which a researcher administered the therapy. In this study, a
      portable BCI-FES system will be used with an inexpensive consumer BCI, which is designed for
      non-professionals. The primary objective is to assess whether it is feasible for caregivers
      and patients to learn to operate the portable BCI-FES system on their own within 5 training
      sessions. The secondary objectives are to collect feedback from patients and therapists of
      their views via semi-structured interviews and questionnaires; to assess how stable the
      system parameters (EEG parameters, electrode location, FES stimulation parameters)are over
      time; to assess whether there is any functional and neurological recovery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Successful training for operation of BCI-FES system
time frame: 2 months
description: Number of times patients/caregivers successfully operate BCI-FES system within 30 min
measure: System reliability
time frame: 2 months
description: Number of times patients manage to activate the BCI-FES system
measure: Time taken to use system
time frame: 2 months
description: Average time required to accomplish BCI-FES therapy (excluding setup time)
measure: NASA task load index
time frame: 2 months
description: Score from National Aeronautics and Space Administration (NASA) Task Load Index questionnaire
measure: Psychological Effect of Assistive Devices
time frame: 2 months
description: Score of Psychological Effect of Assistive Devices questionnaire
measure: Quebec User Evaluation of Satisfaction with Assistive Technology
time frame: 2 months
description: Score of Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire
measure: Grip strength
time frame: Baseline and 2 months
description: Change in grip strength
measure: Hand range of motion
time frame: Baseline and 2 months
description: Change in hand range of motion
arm group label: BCI-FES hand therapy
arm group type: Experimental
description: BCI-FES hand therapy sessions (set up and use of system)
intervention type: Procedure
intervention name: BCI-FES hand therapy
description: BCI-FES rehabilitation therapy of the upper limb
arm group label: BCI-FES hand therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aleksandra Vuckovic, BEng MSc PhD
role: Study Director
affiliation: University of Glasgow
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
sharing ipd: No