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

Overseen By Astrea Villarroel-Sanchez, 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

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 roughly 50 intervention, verification, and follow-up sessions over 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.

How does the treatment of Brain and Spinal Cord Stimulation + Hand Training for Spinal Cord Injury differ from other treatments?

This treatment is unique because it combines brain and spinal cord stimulation with hand training to enhance recovery after spinal cord injury. It leverages techniques like transcutaneous spinal cord stimulation (tSCS) and synaptic pairing to boost neuroplasticity (the brain's ability to reorganize itself), which is not typically seen in standard rehabilitation methods. ^{1 2}

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. Switzerland pubmed.ncbi.nlm.nih.gov

Brain-Computer Interface Priming for Cervical Transcutaneous Spinal Cord Stimulation Therapy: An Exploratory Case Study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effects of Remote Ischemic Conditioning on Hand Engagement in individuals with Spinal cord Injury (RICHES): protocol for a pilot crossover study. [2022]