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

Last updated: October 21, 2025
Sponsor: Bronx VA Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Cord Injuries

Treatment

Bouts

SCAP plus Exercise

Synaptic Pairing Interval

Clinical Study ID

NCT06104735
1777667
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age between 18-85 years.

  • Must have stable prescription medication for 30 days prior to screening

  • Must be able to: abstain from alcohol, smoking and heavy caffeine consumption on theday of each experiment; abstain from recreational drugs for the entirety of thestudy; commit to study requirements (i.e., 53 visits); provide informed consent.

  • Score of 1-4 (out of 5) on manual muscle testing of finger extension, fingerflexion, or finger abduction in left or right hand.

Exclusion

Exclusion Criteria:

  • Personal or extensive family history of seizures;

  • Ventilator dependence or patent tracheostomy site;

  • History of stroke, brain tumor, brain abscess, or multiple sclerosis;

  • History of severe head trauma requiring neurosurgery;

  • History of implanted brain/spine/nerve stimulators, aneurysm clips, ferromagneticmetallic implants in the head (except for inside mouth); cochlear implants; cardiacpacemaker/defibrillator; intracardiac lines; currently increased intracranialpressure; or other contraindications to brain or spine stimulation;

  • Significant coronary artery or cardiac conduction disease; recent history ofmyocardial infarction and heart failure with an ejection fraction of less than 30%or with a New York Heart Association Functional Classification of Class III or IV;

  • Recent history (within past 6 months) of recurrent autonomic dysreflexia, defined asa syndrome of sudden rise in systolic pressure greater than 20 mm Hg or diastolicpressure greater than 10 mm Hg, without rise in heart rate, accompanied by symptomssuch as headache, facial flushing, sweating, nasal congestion, and blurry vision (this will be closely monitored during all screening and testing procedures);

  • History of significant hearing problems;

  • History of bipolar disorder;

  • History of suicide attempt;

  • Active psychosis;

  • Recent history (>1 year) of chemical substance dependency or significantpsychosocial disturbance;

  • Heavy alcohol consumption (greater than equivalent of 5oz of liquor) within previous 48 hours;

  • Open skin lesions over the face, neck, shoulders, or arms;

  • Pregnancy; and

  • Unsuitable for study participation as determined by study physician.

Study Design

Total Participants: 12
Treatment Group(s): 6
Primary Treatment: Bouts
Phase:
Study Start date:
May 24, 2024
Estimated Completion Date:
December 31, 2026

Study Description

See above.

Connect with a study center

  • James J. Peters VA Medical Center, Bronx, NY

    Bronx, New York 10468
    United States

    Site Not Available

  • James J. Peters VA Medical Center, Bronx, NY

    The Bronx 5110266, New York 5128638 10468
    United States

    Active - Recruiting

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