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

Recruiting in Palo Alto (17 mi)

Overseen byNoam Y Harel, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Bronx VA Medical Center

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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.

I am between 18 and 85 years old.

+3 more

Exclusion Criteria

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

Pregnancy

I have had significant hearing issues.

+15 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: All participantsExperimental Treatment6 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.