NCT06716112

Paired Vagus Nerve Stimulation Mechanisms

Mechanisms of Paired Vagus Nerve Stimulation (VNS) in Chronic Stroke: a Randomized, Blinded, Sham-controlled, Single-center Mechanistic Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 22 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Stroke

Interventions

Type	Name	Description
DEVICE	Vagus Nerve Stimulation (VNS) Device	All patients will be implanted with the ReStore VNS device by an NYU neurosurgeon. During treatment sessions, study personnel will deliver a VNS burst at the completion of a training movement by pressing a button on a smart device, which wirelessly triggers active VNS stimulation.
DEVICE	Sham VNS Device	All patients will be implanted with the ReStore VNS device by an NYU neurosurgeon. During treatment sessions, study personnel will deliver a VNS burst at the completion of a training movement by pressing a button on a smart device, which wirelessly triggers sham VNS stimulation.
BEHAVIORAL	Upper Extremity Rehabilitation	Rehabilitation training will be functional and activity-based, focusing on six task categories: reaching and grasping objects, gross movements with objects, flipping objects, inserting objects, self-feeding, and opening and closing containers. Three 90-minute training sessions per week will be administered by a licensed occupational therapist, over two six-week treatment blocks. Sessions will be paired with either active or sham VNS administration.

Timeline

• Start date: 2025-07-15
• Primary completion: 2029-05-01
• Completion: 2029-09-01
• First posted: 2024-12-04
• Last updated: 2025-07-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study