Vagus Nerve Stimulation for Stroke

Palo Alto (17 mi)

Overseen byHeidi Schambra, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: NYU Langone Health

No Placebo Group

Trial Summary

What is the purpose of this trial?In this mechanistic study, 40 individuals with chronic stroke will be implanted with a small vagus nerve stimulation (VNS) device. The study will use a randomized, blinded, crossover design to deliver two conditions in six-week blocks: active VNS or sham VNS, each paired with upper extremity (UE) motor rehabilitation. Assessment visits will occur before and after each block, and will examine neural pathway strength, functional connectivity, and motor and non-motor behaviors. Investigators will test for VNS-induced changes in motor, cognitive, and affective systems, and will identify biomarkers predictive of clinical response.

Eligibility Criteria

This trial is for individuals who have had a stroke and are now in the chronic phase. They must be suitable candidates for having a small device implanted that stimulates the vagus nerve, which is part of the body's internal control system. Participants will undergo upper extremity rehabilitation as part of the study.

Inclusion Criteria

My arm's movement ability scores between 20 to 50 on a specific test.

I have slight to moderate disability but can walk without assistance.

I am between 22 and 79 years old.

I am a suitable candidate for a surgical procedure to implant a VNS device.

Exclusion Criteria

I have had bleeding in my brain or a traumatic brain injury.

I have severe muscle stiffness.

I am not on any medication that affects nerve signals.

Treatment Details

The study tests if stimulating the vagus nerve with an implanted device can help recovery from stroke when paired with arm rehabilitation exercises. It compares real stimulation (active VNS) to fake stimulation (sham VNS) using a blinded crossover design, meaning participants will experience both conditions without knowing which one they're receiving at any time.

2Treatment groups

Experimental Treatment

Group I: Sham VNS first, then Active VNSExperimental Treatment3 Interventions

Patients will undergo two 6-week intervention blocks, receiving sham VNS first and active VNS second. Blocks consist of three 90-minute sessions per week with a licensed occupational therapist (OT). During these sessions, patients will perform rehabilitation training activities paired with sham VNS during the first block and paired with active VNS during the second block.

Group II: Active VNS first, then Sham VNSExperimental Treatment3 Interventions

Patients will undergo two 6-week intervention blocks, receiving active VNS first and sham VNS second. Blocks consist of three 90-minute sessions per week with a licensed occupational therapist (OT). During these sessions, patients will perform rehabilitation training activities paired with active VNS during the first block and paired with sham VNS during the second block.