Wireless Nerve Stimulation Device To Enhance Recovery After Stroke

NAUnknownINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 1, 2021

Primary Completion Date

January 31, 2025

Study Completion Date

January 31, 2025

Conditions
StrokeChronic StrokeUpper Extremity ParesisIschemic StrokeHemorrhagic Stroke
Interventions
DEVICE

Active Vagus Nerve Stimulation

Stimulation of the vagus nerve that is paired with upper limb rehabilitation. VNS stimulation as described in the current study consists of 0.5 second trains of 0.8 mA; 100 µsec biphasic pulses at 30 Hz. Stimulation trains are delivered only during rehabilitation.

DEVICE

Placebo Vagus Nerve Stimulation

During Phase 1 of the study, the placebo group will receive a minimal amount of stimulation that fails to sufficiently activate the nerve, unknown to the participant and therapists. All participants will receive active stimulation during the Phase 2 open-label portion of the study.

Trial Locations (1)

75246

RECRUITING

Baylor Scott & White Institute for Rehabilitation, Dallas

Sponsors
All Listed Sponsors
collaborator

The University of Texas at Dallas

OTHER

collaborator

University of Texas Southwestern Medical Center

OTHER

collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

lead

Baylor Research Institute

OTHER