James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468, United States
Location status: Recruiting
NCT Number: NCT06104735
While physical exercise remains the foundation for any rehabilitation therapy, the team seeks to improve the benefits of exercise by combining it with the concept of "Fire Together, Wire Together" - when brain stimulation is synchronized with spinal cord stimulation, nerve circuits in the spinal cord strengthen - a phenomenon termed "Spinal Cord Associative Plasticity", or SCAP.
This project will build on the team's promising preliminary findings. When one pulse of brain stimulation is synchronized with one pulse of cervical spinal stimulation, hand muscle responses are larger than with brain stimulation alone or unsynchronized stimulation. However, the team does not know the best ways to apply SCAP repetitively, especially in conjunction with exercise, to increase and extend improvements in clinical function. Do ideal intervention parameters vary across individuals, or do they need to be customized?
The team will take a systematic approach with people who have chronic cervical SCI to determine each person's best combination of SCAP with task-oriented hand exercise. Participants will undergo up to 53 intervention, verification, and follow-up sessions over a period of 6 to 10 months each. The team will measure clinical and physiological responses of hand and arm muscles to each intervention.
Regaining control over hand function represents the top priority for individuals with cervical SCI. Furthermore, this approach could be compatible with other future interventions, including medications and cell-based treatments.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Not applicable
The Bronx, New York, 10468, United States
Location status: Recruiting
See above.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Optimize interstimulus pairing between brain and spinal cord stimulation.
Compare 2 Hz continuous to intermittent theta burst frequency
Compare effects of 1, 2, or 4 bouts of SCAP
Compare 6 versus 12 minutes of rest in between bouts of SCAP
Task-oriented hand exercises
Compare interleaved versus serial bouts of SCAP and exercise.
Time frame: Through study completion, up to 10 months
The primary neurophysiological outcome will be corticospinal excitability measured at the target muscle. The target muscle will be determined during the first evaluation session, with preference for first dorsal interosseous (FDI), abductor pollicis brevis (APB), or extensor carpi radialis (ECR) muscles based on muscle excitability and consistency. TMS recruitment curves will be collected. The amplitude of target muscle responses to TMS and spinal cord stimulation will be compared after the various interventions.
Time frame: Through study completion, up to 10 months
Maximal isometric pinch strength will be measured in key-pinch (lateral edge of the index finger and the thumb) and tip-to-tip (tips of first and third finger) configurations using a pinch dynamometer. Grip strength will be measured using a hand dynamometer. For each type of pinch or grip, three trials will be conducted by holding the dynamometer with maximal volitional force for 3-5 seconds, with at least 30 seconds or more between trials. The highest achieved value will be used for analysis.
Contact information is provided by the study sponsor or research team.
Bronx VA Medical Center
Fed
Optimizing Spinal Cord Associative Plasticity to Enhance Response to Hand Training in Cervical Spinal Cord Injury
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