Targeted Plasticity Therapy for Upper Limb Rehabilitation in Spinal Cord Injuries

NAUnknownINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

February 15, 2021

Primary Completion Date

November 30, 2023

Study Completion Date

April 30, 2025

Conditions
Spinal Cord InjuriesUpper Extremity Paresis
Interventions
DEVICE

Active Vagus Nerve Stimulation

Stimulation of the vagus nerve that is paired with upper extremity rehabilitation. VNS stimulation as described in the current study consists of 0.5 s trains of 0.8 mA 100 µs biphasic pulses delivered 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 University Medical Center, Dallas

Sponsors
All Listed Sponsors
collaborator

Wings for Life

OTHER

collaborator

Defense Advanced Research Projects Agency

FED

collaborator

The University of Texas at Dallas

OTHER

collaborator

University of Texas Southwestern Medical Center

OTHER

lead

Baylor Research Institute

OTHER