Brain and Spinal Cord Stimulation + Hand Training for Spinal Cord Injury

Recruiting at 1 trial location

Overseen By Francisco Castano, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bronx VA Medical Center

Must not be taking: Amphetamines, Neuroleptics, Dalfampridine, Bupropion

Disqualifiers: Seizures, Stroke, Head trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 50

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve hand function in people with chronic spinal cord injuries by combining brain and spinal cord stimulation with hand exercises. The research focuses on finding the best way to use synchronized pulses to strengthen nerve circuits, enhancing the benefits of physical exercise. Participants will undergo sessions to assess how different combinations of these treatments affect their hand and arm muscles. This trial suits individuals with cervical spinal cord injuries who have difficulty with hand movements such as finger extension or flexion. As an unphased trial, participants can contribute to groundbreaking research that may lead to new rehabilitation methods.

Do I have to stop taking my current medications for the trial?

You need to have stable prescription medication for 30 days before the trial starts, but the protocol doesn't specify if you need to stop taking any current medications during the trial.

What prior data suggests that this method is safe for spinal cord injury rehabilitation?

Research has shown that combining brain and spinal cord stimulation, known as Spinal Cord Associative Plasticity (SCAP), is generally well-tolerated. Studies have found that SCAP, when used with exercise, can safely enhance hand and arm function in individuals with spinal cord injuries. Early data suggest that this technique, which coordinates brain and spinal cord stimulation, does not cause major side effects. Specifically, another study found that similar paired stimulation methods are safe and can easily integrate into regular rehabilitation programs. While more research is needed to determine the best applications for SCAP, current evidence suggests it is a promising and safe option for improving hand control. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a combination of brain and spinal cord stimulation with hand training for spinal cord injuries, a novel approach compared to current treatments. Unlike standard therapies that often focus solely on physical rehabilitation, this method aims to enhance neural recovery by optimizing the timing and frequency of stimulation in conjunction with exercise. By potentially improving the brain-spine connection and synaptic pairing, the treatment could lead to more effective recovery and functional improvement for patients. This innovative approach might offer new hope for restoring motor function in individuals with spinal cord injuries.

What evidence suggests that this trial's treatments could be effective for spinal cord injury?

Research has shown that combining brain and spinal cord stimulation with hand exercises can improve hand muscle responses in people with spinal cord injuries. In this trial, participants will experience varying conditions to determine the optimal timing and combination of these interventions. Previous studies found that when brain stimulation was timed with spinal cord stimulation, hand muscles responded better than with brain stimulation alone. This supports the idea that "Fire Together, Wire Together," meaning that activating nerve circuits together can strengthen them, might help improve hand function. Studies have also demonstrated that this combined method can significantly improve arm and hand function. These early findings suggest that using brain and spinal cord stimulation along with exercise could be a promising way to help people with spinal cord injuries regain hand control. ^{1 2 3 6 7}

Who Is on the Research Team?

Noam Y Harel, MD, PhD

Principal Investigator

JAMES J. PETERS VAMC

Are You a Good Fit for This Trial?

Adults aged 18-85 with stable cervical spinal cord injury (SCI) who can commit to many visits over 6-10 months, abstain from alcohol and heavy caffeine on experiment days, and have a certain level of hand muscle movement. Excluded are those with seizure risks, ventilator dependence, brain conditions like stroke or tumors, implanted stimulators or metal in the head, severe heart issues, skin lesions on upper body or pregnancy.

Inclusion Criteria

I can move my fingers but not fully.

My medication has not changed in the last 30 days.

Must be able to abstain from alcohol, smoking and heavy caffeine consumption on the day of each experiment

Exclusion Criteria

You currently have severe mental health issues that affect your thoughts and behavior.

Pregnancy

I have had significant hearing issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo SCAP with task-oriented hand exercise to determine optimal parameters

6-10 months

Roughly 50 sessions

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bouts
• Exercise
• Frequency
• SCAP plus Exercise
• Spacing
• Synaptic Pairing Interval

Trial Overview The trial is testing how synchronized brain and spinal cord stimulation combined with hand exercises can help people with chronic cervical SCI improve their hand function. It explores the best ways to apply this 'Spinal Cord Associative Plasticity' through numerous sessions tailored to each participant's response.

How Is the Trial Designed?

Group I: All participants Experimental Treatment 6 Interventions

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.

Who Is Running the Clinical Trial?

Bronx VA Medical Center

Lead Sponsor

Trials

22

Recruited

1,300+

Bronx Veterans Medical Research Foundation, Inc

Collaborator

Trials

10

Recruited

750+

New York State Department of Health

Collaborator

Trials

35

Recruited

447,000+

Citations

1. ninds.nih.gov ninds.nih.gov/health-information/clinical-trials/spinal-cord-associative-plasticity-study

Spinal Cord Associative Plasticity Study The goal of this project is to translate a promising therapy for improving arm and hand function after partial spinal cord injury to humans. The approach ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06104735

Finding the Best Combination of Brain and Spinal Cord ... 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 ...

3. withpower.com withpower.com/trial/phase-amyotrophic-lateral-sclerosis-2-2024-8afc3

SCAP and Hand Exercises for ALS A multicenter randomized clinical trial is investigating the effectiveness of combining spinal cord transcutaneous stimulation (scTS) with activity-based ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1878747925002569

Paired associative stimulation improves outcomes when ... Improvement from baseline was observed at the end of stimulation (active: 346 ​± ​53 ​%, sham: 215 ​± ​26 ​%), 1 year after injury (about 6 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2562625/

Activity-dependent plasticity in spinal cord injury - PMC In this review, we discuss central nervous system (CNS) plasticity after SCI, occurring both spontaneously after injury and in response to rehabilitative ...

6. reporter.nih.gov reporter.nih.gov/project-details/11053339

RePORT RePORTER - National Institutes of Health (NIH) | Transcutaneous spinal cord stimulation (TSCS) has demonstrated remarkable potential to activate damaged circuits after SCI to improve motor and autonomic ...

7. tandfonline.com tandfonline.com/doi/full/10.1080/10790268.2025.2539032

Full article: 2025 Poster Abstracts P1–P18 Our preliminary data using Spinal Cord Associative Plasticity (SCAP), an intervention of paired brain and spinal cord stimulation, has ...