Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06104735

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

Led by Bronx VA Medical Center · Updated on 2025-10-22

12

Participants Needed

1

Research Sites

135 weeks

Total Duration

On this page

Sponsors

B

Bronx VA Medical Center

Lead Sponsor

B

Bronx Veterans Medical Research Foundation, Inc

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 85 years
  • Stable prescription medication for at least 30 days before screening
  • Able to abstain from alcohol, smoking, and heavy caffeine on experiment days
  • Able to abstain from recreational drugs throughout the study
  • Willing to commit to all study requirements including up to 53 visits
  • Able to provide informed consent
  • Manual muscle test score of 1 to 4 out of 5 on finger extension, flexion, or abduction in either hand
Not Eligible

You will not qualify if you...

  • Personal or extensive family history of seizures
  • Dependence on a ventilator or having a patent tracheostomy
  • History of stroke, brain tumor, brain abscess, or multiple sclerosis
  • History of severe head trauma requiring brain surgery
  • Presence of implanted brain/spine/nerve stimulators, aneurysm clips, metal implants in the head (except inside mouth), cochlear implants, pacemaker/defibrillator, or intracardiac lines
  • Increased intracranial pressure or other contraindications to brain or spine stimulation
  • Significant coronary artery or heart conduction disease
  • Recent heart attack or heart failure with ejection fraction below 30% or severe heart failure symptoms
  • Recent recurrent autonomic dysreflexia within past 6 months
  • Significant hearing problems
  • History of bipolar disorder or suicide attempt
  • Active psychosis
  • Chemical substance dependency or major psychosocial problems within past year
  • Heavy alcohol use within 48 hours before study
  • Open skin wounds on face, neck, shoulders, or arms
  • Pregnancy
  • Any condition making participation unsuitable as determined by study doctor

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, United States, 10468

Actively Recruiting

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Research Team

F

Francisco Castano, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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