Assessment of Neural Signals for the Control of Assistive Devices for Spinal Cord Injury
This study is looking at how brain signals can be used to control assistive devices for people with spinal cord injury (SCI). Researchers will use Epidural Spinal Cord Stimulation (ESCS), a surgical procedure where electrodes are placed near the spinal cord, and record brain activity using Electrocorticographic (ECoG) or Electroencephalographic (EEG) devices. The goal is to understand how brain signals related to movement can trigger ESCS to improve arm and hand function. You might be able to join if you are 18 or older, have chronic SCI (C4-T1 neurological injury with some remaining function), and are not in other studies. The study aims to see if there's a change in hand motor function and hand motor evoked potential (a measure of nerve activity) up to two months after the ESCS implant. The current recruitment status is unclear, and the study plans to enroll 3 participants.
- Study design
- This is an interventional study with a planned enrollment of 3 participants. It is not specified if it is randomized, blinded, or its phase.
- What's involved
- You would undergo a one-time surgery for Epidural Spinal Cord Stimulation (ESCS) lasting no more than 2 hours. Neural activity will be recorded during upper and/or lower extremity tasks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Changes in hand motor function and motor evoked potential will be measured up to 2 months post-implant.
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Assessment of Neural Signals for the Control of Assistive Devices
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Jonathan R Jagid, MD · PRINCIPAL_INVESTIGATOR · University of Miami
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in Hand Motor FunctionBaseline, up to 2 months post-implant
Toronto Rehabilitation Institute Hand Function Test (TRI-HFT): Measured on a scale from 0-133 to assess upper extremity manipulation and grip force at time points before and after implant. Higher scores indicate better hand motor function.
- Change in Hand Motor Evoked Potential (MEP)Baseline, up to 2 months post-implant
Change in Motor Evoked Potential (MEP): MEP evaluates corticospinal excitability (strength of the connections between the brain and the muscles). The excitability is measured as a peak-to-peak amplitude in millivolts (mV).