Recruiting

SCAP with Exercise

Sponsor:

Bronx VA Medical Center

Code:

NCT06104735

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Synaptic Pairing Interval

Frequency

Bouts

Spacing

Exercise

Study Details

Brief 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

Study ID

NCT06104735

Start date

May 24, 2024

Status verified date

Oct, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 the day of each experiment; abstain from recreational drugs for the entirety of the study; 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, finger flexion, or finger abduction in left or right hand.

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, ferromagnetic metallic implants in the head (except for inside mouth); cochlear implants; cardiac pacemaker/defibrillator; intracardiac lines; currently increased intracranial pressure; or other contraindications to brain or spine stimulation;
  • Significant coronary artery or cardiac conduction disease; recent history of myocardial 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 as a syndrome of sudden rise in systolic pressure greater than 20 mm Hg or diastolic pressure greater than 10 mm Hg, without rise in heart rate, accompanied by symptoms such 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 significant psychosocial 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

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Synaptic Pairing Interval

Optimize interstimulus pairing between brain and spinal cord stimulation.

Frequency

Compare 2 Hz continuous to intermittent theta burst frequency

Bouts

Compare effects of 1, 2, or 4 bouts of SCAP

Spacing

Compare 6 versus 12 minutes of rest in between bouts of SCAP

Exercise

Task-oriented hand exercises

SCAP plus Exercise

Compare interleaved versus serial bouts of SCAP and exercise.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Francisco Castano, MPH

718-584-9000francisco.castano@va.gov

Locations

James J. Peters VA Medical Center, Bronx, NY

Recruiting

The Bronx, New York, United States, 10468

Contacts

Francisco Castano, MPH

718-584-9000francisco.castano@va.gov

Principal Investigator:

Noam Y. Harel, MD, PhD

More Information

Sponsor

Bronx VA Medical Center

Last update posted

Oct 22, 2025

Last verified

Oct, 2025

Keywords

  • neuromodulation
  • spinal cord stimulation
  • task-oriented exercise
  • transcranial magnetic stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bronx VA Medical Center on 2025-10-22.