Transspinal Stimulation and Blood Flow Restricted Exercise for Tetraplegia
This study is looking at new ways to improve movement and function in people with chronic, incomplete tetraplegia (paralysis affecting all four limbs). Researchers want to see if combining Blood Flow Restricted Exercise (BES) with Transspinal Stimulation (TS) can help more than BES combined with a sham (inactive) TS treatment. Both groups will also do repetitive practice of activities. You might be able to join if you are between 18 and 70 years old, have had a spinal cord injury for over a year, and have a companion to help you. The study will measure changes in your hand function and grip strength over 20 weeks to see if the treatments are successful. The study plans to enroll 44 participants, but its current status is unclear.
- Study design
- This is an interventional study comparing two different treatment approaches. It plans to enroll 44 participants.
- What's involved
- The total study duration is 30 weeks, with the first 4 weeks involving baseline assessments. You will need a companion to help you throughout the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your hand function and grip strength will be measured from the start of the study up to 20 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia
At a glance
Conditions
Where it's being run
3 sites across 1 statesStudy leadership
- Ashraf Gorgey, MPT, PhD, FACSM, FACRM · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Change in hand functional activitiesBaseline to 20 weeks
The grasp and release test is a standardized test of functional activities depending on hand function in persons with cSCI. Participants will be asked to lift and move a peg, block, can, 1 lb. dumbbell weight and fork from lateral to medial over a 60 cm distance and release at midline.
- Change in maximum grip strength without TSBaseline to 20 weeks
Using a standard hand-grip dynamometer, participants will be asked to squeeze the dynamometer with one hand at a time as strongly as possible for up to 3 seconds, to obtain a measure of the maximal voluntary force they can generate when closing their hand
- Change in maximum grip strength with TSBaseline to 20 weeks
Using a standard hand-grip dynamometer, participants will be asked to squeeze the dynamometer with one hand at a time as strongly as possible for up to 3 seconds, to obtain a measure of the maximal voluntary force they can generate when closing their hand with the addition of TS over the skin targeting the cervical spinal cord
- Change in electrical activity activation with TSBaseline to 20 weeks
During the assessment of maximal grip strength with TS, electromyography (EMG) will be used to measure the amount of neuromuscular electrical activation from the following muscle groups: wrist flexors, wrist extensors, elbow flexors, and elbow extensors.
- Change in EMG activation without TSBaseline to 20 weeks
During the assessment of maximal grip strength without TS, electromyography (EMG) will be used to measure the amount of neuromuscular electrical activation: wrist flexors, wrist extensors, elbow flexors, and elbow extensors.
- Change in tactile perceptionBaseline to 20 weeks
The Semmes-Weinstein Monofilament Exam is used to assess cutaneous tactile perception in individuals with spinal cord injury to provide more precise assessment of sensory function. Semmes-Weinstein Monofilaments are small, thin fibers attached to a handle that bend once a certain amount of force (ranging from 0.07 - 300 grams) is applied. With eyes closed, participants will be asked whether they can feel a light touch from the monofilaments at standard locations on the palm and dorsum of the hand and fingers. Participants are given a score depending on what the thinnest filament and thus, what the smallest amount of force is which needs to be applied for them to perceive a tactile stimulus.