Brain and Spinal Cord Stimulation + Hand Training for Spinal Cord Injury
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.12345
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.12367
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants undergo SCAP with task-oriented hand exercise to determine optimal parameters
Follow-up
Participants are monitored for safety and effectiveness after intervention
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?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bronx VA Medical Center
Lead Sponsor
Bronx Veterans Medical Research Foundation, Inc
Collaborator
New York State Department of Health
Collaborator
Citations
1.
ninds.nih.gov
ninds.nih.gov/health-information/clinical-trials/spinal-cord-associative-plasticity-studySpinal 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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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