Paired Vagus Nerve Stimulation Mechanisms

NARecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

July 15, 2025

Primary Completion Date

May 31, 2029

Study Completion Date

September 30, 2029

Conditions
Chronic Stroke
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."

Trial Locations (2)

10016

RECRUITING

NYU Langone Health, New York

75080

RECRUITING

The University of Texas at Dallas, Richardson

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

University of Texas at Dallas

UNKNOWN

lead

NYU Langone Health

OTHER