taVNS for Upper Limb Rehabilitation

Stroke Clinical Trial

Official title: Optimization of Closed-loop Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) as a Neurorehabilitation Tool

Status Completed

Clinical Trial Summary

This study explores the use of a new form of neuromodulation known as transcutaneous auricular vagus nerve stimulation (taVNS) which stimulates the ear. This stimulation will be delivered concurrently with upper limb motor rehabilitation training (3 days/week for 4 weeks) in chronic stroke patients. Patients will undergo a series of baseline assessments (including a brain scan), a 4-week course of motor rehabilitation, and post-assessments (including a second brain scan)

Clinical Trial Description

This study aims to refine and develop closed loop taVNS, establish activity with key biomarkers, and show initial feasibility in a small clinical trial. For paired taVNS to succeed as a clinical treatment, it is critical to develop and refine a closed-loop taVNS platform that delivers stimulation concurrently during specific movements of the motor rehabilitation training.

Aim 1 develops this novel motion-gated closed-loop system that delivers taVNS in synchrony with specific upper limb motor activation (n=5) Aim 2 will combine the development of the closed-loop system with the investigator's mechanistic understanding to explore an open-label pilot trial (n=20) using closed-loop taVNS paired with task-specific training to determine the feasibility, safety, and potential effect size of this novel combination therapy. ;

Related Conditions & MeSH terms

• Stroke

• NCT number: NCT04129242
• Study type: Interventional
• Source: Medical University of South Carolina
• Status: Completed
• Phase: Early Phase 1
• Start date: February 19, 2020
• Completion date: October 5, 2022