Back to search results

Brain and Spinal Cord Stimulation with Hand Training After Spinal Cord Injury

This study, NCT06104735, is looking for people aged 18 to 85 with spinal cord injuries to find the best way to combine brain and spinal cord stimulation with hand training. The goal is to strengthen nerve connections in the spinal cord, a process called "Spinal Cord Associative Plasticity" (SCAP), to improve hand function. Researchers are testing different ways to deliver the stimulation, including varying the timing between brain and spinal cord pulses (Synaptic Pairing Interval), the frequency of stimulation (2 Hz continuous vs. intermittent theta burst), the number of stimulation sessions (1, 2, or 4 bouts of SCAP), and the rest time between sessions (6 vs. 12 minutes). All participants will also do task-oriented hand exercises. Success will be measured by how much the hand muscles respond to stimulation. The study plans to enroll 12 participants, but its current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 12 participants. The phase of the study is not specified.
What's involved
You would need to commit to 53 visits. You must also abstain from alcohol, smoking, and heavy caffeine on experiment days, and from recreational drugs for the entire study.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, amplitude of motor evoked potential, will be measured through study completion, up to 10 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06104735

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

Recruiting
NAAges 18–85InterventionalTreatment
Bronx VA Medical Center
~12 participants
Updated 2025-10-22 on ClinicalTrials.gov
What's tested:Synaptic Pairing IntervalFrequencyBoutsSpacingExerciseSCAP plus Exercise

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Amplitude of motor evoked potential at the target muscle.
Measured over Through study completion, up to 10 months

Conditions

Spinal Cord Injuries

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
New York1

Study leadership

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

Who to contact

Francisco Castano, MPH
[email protected]
718-584-9000 · ext. 5824
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Amplitude of motor evoked potential at the target muscle.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.