NCT06104735

Finding the Best Combination of Brain and Spinal Cord Stimulation With Hand Training After Spinal Cord Injury

Optimizing Spinal Cord Associative Plasticity to Enhance Response to Hand Training in Cervical Spinal Cord Injury

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Bronx VA Medical Center · Federal
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

See above.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
PROCEDURE	Synaptic Pairing Interval	Optimize interstimulus pairing between brain and spinal cord stimulation.
PROCEDURE	Frequency	Compare 2 Hz continuous to intermittent theta burst frequency
PROCEDURE	Bouts	Compare effects of 1, 2, or 4 bouts of SCAP
PROCEDURE	Spacing	Compare 6 versus 12 minutes of rest in between bouts of SCAP
PROCEDURE	Exercise	Task-oriented hand exercises
PROCEDURE	SCAP plus Exercise	Compare interleaved versus serial bouts of SCAP and exercise.

Timeline

• Start date: 2024-05-24
• Primary completion: 2026-11-30
• Completion: 2026-12-31
• First posted: 2023-10-27
• Last updated: 2025-10-22

Locations

1 site across 1 country: United States