Motor Conditioning to Enhance the Effect of Physical Therapy

Technology
Arm/hand function
Online since 5 November 2021, updated 894 days ago

About this trial

This trial is enrolling individuals with cervical (neck area) spinal cord injuries to test a brain-controlled device paired with another stimulation device to activate hand muscles. A brain-computer interface (BCI) device records brain signals corresponding to a visual cue — e.g., a hand squeezing a ball. With training, users can initiate movements on the screen using their thoughts. These movements can then be used to activate functional electrical stimulation (FES), a technique that applies electrical current through the skin to nerves to contract weakened or paralyzed muscles. Thus, a motor command from the brain is recorded by BCI and sent to the FES device (BCI-FES). The study will measure functional changes (range of movement, muscle strength, grip force, independence), neurological outcomes (electroencephalogram or EEG activity), and quality of life factors. If selected for the trial, participants will each receive 20 physical therapy sessions of matched duration (40-50 min) of their dominant hand. They will be randomly assigned to one of two study groups: 1) participating in physical therapy only (control group); or 2) the treatment group, with BCI-FES and physical therapy. Researchers will measure changes in hand function after stimulation and before adding physical therapy; they want to see if this sequence conditions the hands to better respond to the therapy.

Included participants

Gender
All
Age
18 - 80 years
Injury level
C3 - C8
  • Severity (AIS)?
  • AIS-B
    AIS-C
    AIS-D
    Time since injury
    3 days - 6 months
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C3-C8
    Additionally, participants must
    NOT have general contraindications for FES -- no implanted devices, no pregnancy, no automatic dysreflexia

    What’s involved

    Type

    Technology

    Details

    All participants will complete a total 20 sessions, each lasting 40 to 60 minutes, over a period of about 7 weeks (~3 sessions per week). All participants will complete a series of assessments before starting the first session, within a week of completing the last session, and three months after completing the last session. These assessments include independence, hand function (range of movement, muscle strength, grip force, independence), neurological function (electroencephalogram or EEG activity), and feedback on the therapy. In addition, after the 1st, 5th, 10th, 15th, and 20th participants will complete a questionnaire that measured the level of mental work they experienced during the session. Participants randomized to the intervention will complete 30 minutes of BCI-FES immediately followed by 30 minutes of hand therapy in each session. Participants randomized to the control group will complete 40 minutes of hand therapy in each session.

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    General health

    Mental health and psychosocial factors

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Ended
    • Trial start date
    • 9 Dec 2020
    • Organisation
    • NHS Greater Glasgow and Clyde
    • Trial recruitment status
    • Ended
    • Trial start date
    • 9 Dec 2020
    • Organisation
    • NHS Greater Glasgow and Clyde

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more