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

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.

Conditions

• Spinal Cord Injuries

Interventions

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.

Sponsors & Collaborators

• Bronx Veterans Medical Research Foundation, Inc

  collaborator OTHER

• New York State Department of Health

  collaborator OTHER_GOV

• Bronx VA Medical Center

  lead FED

Principal Investigators

• Noam Y Harel, MD, PhD · JAMES J. PETERS VAMC

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-24

Primary Completion

2026-11-30

Completion

2026-12-31

Countries

• United States

Study Locations