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

NCT06104735 | Recruiting

• 1 other identifier: 1777667
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Amplitude of motor evoked potential at the target muscle.

  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 Outcomes (1)

• Pinch and grip strength

  Through study completion, up to 10 months

Study Arms (1)

All participants

EXPERIMENTAL

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; Procedure: Frequency; Procedure: Bouts; Procedure: Spacing; Procedure: Exercise; Procedure: SCAP plus Exercise

Interventions

Synaptic Pairing Interval PROCEDURE

Optimize interstimulus pairing between brain and spinal cord stimulation.

All participants

Frequency PROCEDURE

Compare 2 Hz continuous to intermittent theta burst frequency

All participants

Bouts PROCEDURE

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

All participants

Spacing PROCEDURE

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

All participants

Exercise PROCEDURE

Task-oriented hand exercises

All participants

SCAP plus Exercise PROCEDURE

Compare interleaved versus serial bouts of SCAP and exercise.

All participants

Eligibility Criteria

• Age: 18 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bronx VA Medical Center: lead
• Bronx Veterans Medical Research Foundation, Inc: collaborator
• New York State Department of Health: collaborator

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Exercise; SREBP cleavage-activating protein

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Noam Y Harel, MD, PhD

  JAMES J. PETERS VAMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco Castano, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Each participant will undergo multiple conditions and verifications in an "n-of-1" design.

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: May 24, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 22, 2025

Record last verified: 2025-10

Locations

US (1)