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

October 21, 2025 updated by: Noam Y. Harel, Bronx VA Medical Center

Optimizing Spinal Cord Associative Plasticity to Enhance Response to Hand Training in Cervical Spinal Cord Injury

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

See above.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10468
        • Recruiting
        • James J. Peters VA Medical Center, Bronx, NY
        • Contact:
        • Principal Investigator:
          • Noam Y. Harel, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amplitude of motor evoked potential at the target muscle.
Time Frame: Through study completion, up to 10 months
The primary neurophysiological outcome will be corticospinal excitability measured at the target muscle. The target muscle will be determined during the first evaluation session, with preference for first dorsal interosseous (FDI), abductor pollicis brevis (APB), or extensor carpi radialis (ECR) muscles based on muscle excitability and consistency. TMS recruitment curves will be collected. The amplitude of target muscle responses to TMS and spinal cord stimulation will be compared after the various interventions.
Through study completion, up to 10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pinch and grip strength
Time Frame: Through study completion, up to 10 months
Maximal isometric pinch strength will be measured in key-pinch (lateral edge of the index finger and the thumb) and tip-to-tip (tips of first and third finger) configurations using a pinch dynamometer. Grip strength will be measured using a hand dynamometer. For each type of pinch or grip, three trials will be conducted by holding the dynamometer with maximal volitional force for 3-5 seconds, with at least 30 seconds or more between trials. The highest achieved value will be used for analysis.
Through study completion, up to 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bronx VA Medical Center

Collaborators

Bronx Veterans Medical Research Foundation, Inc
New York State Department of Health

Investigators

  • Principal Investigator: Noam Y Harel, MD, PhD, James J. Peters VAMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2024

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 23, 2023

First Submitted That Met QC Criteria

October 23, 2023

First Posted (Actual)

October 27, 2023

Study Record Updates

Last Update Posted (Estimated)

October 22, 2025

Last Update Submitted That Met QC Criteria

October 21, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1777667

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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