EEG Changes Related to taVNS in Stroke Patients: a Preliminary Study

NARecruitingINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

January 29, 2024

Primary Completion Date

January 31, 2025

Study Completion Date

June 30, 2025

Conditions
Stroke
Interventions
DEVICE

Transcutaneous vagus nerve stimulation

The Parasym Plus device (https://parasym.io) is a transcutaneous auricular vagus nerve stimulator that has been deemed non-significant risk (NSR) by the FDA. Transcutaneous auricular vagus nerve stimulator is a non-significant risk device, as it involves electrical stimulation of the external ear using an ear clip, with no invasive components. The stimulation parameters will be limited to the confines of existing published data. tVNS is safe and well tolerated at doses tested in research studies. The Parasym device is considered low risk when used in accordance with the instructions for use. Participants will be properly trained to use the device, and those with contraindications will be excluded for extra precaution. A low incidence of skin irritation has been reported. No serious adverse events have been reported.

Trial Locations (1)

91769

RECRUITING

Casa Colina Hospital and Centers for Healthcare, Pomona

All Listed Sponsors
collaborator

Foundation for Physical Medicine and Rehabilitation

OTHER

lead

Casa Colina Hospital and Centers for Healthcare

OTHER