Optimizing brain and spinal cord stimulation with hand training after spinal cord injury

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

The team will test whether pairing brain stimulation with cervical spinal cord stimulation plus hand training improves hand strength and function in adults with chronic cervical spinal cord injury.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Bronx VA Medical Center (Federal)
• Locations: 1 site (The Bronx, New York)
• Trial ID: NCT06104735 on ClinicalTrials.gov

What this trial studies

Researchers will use synchronized pulses of transcranial magnetic stimulation and cervical spinal cord stimulation (Spinal Cord Associative Plasticity, SCAP) delivered repeatedly alongside task-oriented hand exercises to try to boost hand muscle responses. The project systematically varies parameters such as synaptic pairing interval, frequency, number of bouts, and spacing to find which combinations give the best and most lasting functional gains. Participants will be adults with chronic cervical spinal cord injuries who have some preserved finger movement and who can attend multiple in-person visits over the course of the protocol. The team will compare synchronized versus unsynchronized stimulation and different parameter sets to determine whether a single approach works broadly or needs individual customization.

Who should consider this trial

Good fit: Adults age 18–85 with chronic cervical spinal cord injury who have some voluntary finger movement (manual muscle testing score 1–4), stable medications, and the ability to commit to repeated in-person visits and study restrictions are ideal candidates.

Not a fit: People with complete absence of voluntary hand movement (MMT 0), active seizures or high seizure risk, ventilator dependence or tracheostomy, implanted stimulators or incompatible metal implants, or major central nervous system diseases (e.g., recent stroke, MS) are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could increase and prolong hand strength and functional hand use for people with chronic cervical spinal cord injury.

How similar studies have performed: Early laboratory and small clinical studies have shown that synchronized brain and spinal stimulation can amplify hand muscle responses, but repetitive SCAP combined with prolonged exercise and individualized parameter optimization is still novel and not yet proven in larger trials.

Eligibility criteria

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.

Where this trial is running

The Bronx, New York

• James J. Peters VA Medical Center, Bronx, NY — The Bronx, New York, United States (Recruiting)

Study contacts

• Principal investigator: Noam Y Harel, MD, PhD — James J. Peters Vamc
• Study coordinator: Francisco Castano, MPH

Conditions Spinal Cord Injuries; neuromodulation; spinal cord stimulation; task-oriented exercise; transcranial magnetic stimulation