Mechanisms of Paired Vagus Nerve Stimulation (VNS) in Chronic Stroke: a Randomized, Blinded, Sham-controlled, Single-center Mechanistic Trial
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 79
Healthy Volunteers: f
View:
• Ability to provide signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• 22-79 years of age
• Unilateral supratentorial ischemic stroke that occurred ≥ 12 months prior to enrollment
• Upper extremity Fugl-Meyer Assessment score of 20 to 50
• Modified Rankin Score of 2, 3, or 4
• Meets all clinical criteria for VNS implantation as determined by the PI and clinical care team
Locations
United States
New York
NYU Langone Health
RECRUITING
New York
Texas
The University of Texas at Dallas
RECRUITING
Richardson
Contact Information
Primary
Heidi Schambra
Heidi.schambra@nyulangone.org
929-455-5128
Time Frame
Start Date:2025-07-15
Estimated Completion Date:2029-09
Participants
Target number of participants:40
Treatments
Experimental: Active VNS first, then Sham VNS
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.
Experimental: Sham VNS first, then Active VNS
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.