Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06716112
NA

Paired Vagus Nerve Stimulation Mechanisms

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

22 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-07-15

Completion Date

2029-09

Last Updated

2025-07-17

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (2)

NYU Langone Health

New York, New York, United States

The University of Texas at Dallas

Richardson, Texas, United States