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

Part of paid clinical trials in The Bronx, New York.

Sponsor
Bronx VA Medical Center
Study ID
NCT06104735
Status
Recruiting
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Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 24, 2024
Status verified
Oct 2025
Primary completion
Nov 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All participants
    Each participant will undergo varying conditions in separate phases to determine optimal: Pairing interval; Frequency; Number of bouts, Inter-bout spacing, and the order of SCAP when given in conjunction with task-oriented hand exercise.

Primary Outcome Measure

Amplitude of motor evoked potential at the target muscle. [ Time Frame: Through study completion, up to 10 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
James J. Peters VA Medical Center, Bronx, NYThe BronxNew York10468
Francisco Castano, MPH
[email protected]
718-584-9000
Noam Y. Harel, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
James J. Peters VA Medical Center, Bronx, NY· The Bronx, NY

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