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ENROLLING BY INVITATION
NCT06623721
NA

Movement-activated Auricular Vagus Nerve Stimulation in Rehabilitation

Sponsor: Olivier Lambercy

View on ClinicalTrials.gov

Summary

Rehabilitation engineering laboratory (RELab) at the ETH Zurich is recruiting participants with a motor function deficit for studying a novel non-invasive brain stimulation method that may be a promising approach for benefiting motor recovery after conditions like stroke, traumatic brain injury or spinal cord injury. The study will be conducted at the cereneo Hertenstein clinic. Participants with residual motor function deficit due to stroke or spine/brain injury will be undergoing typical neurorehabilitation procedures in addition to the use of the automatically controlled non-invasive Vagus nerve stimulation (taVNS). This study will analyze the feasibility of this method before it can be used by doctors generally. More specifically, this study aims to test whether controlling taVNS with a wearable wrist-worn sensor during rehabilitation exercises for movement is both practical and safe. This stimulation works by involves sending tiny electric pulses to the outside of the ear after the wrist sensor detects movement. These pulses activate the auricular Vagus nerve and in turn the brain. Over the course of multiple rehabilitation procedures, taVNS may to help with the speed of motor recovery as shown with previous, manually controlled studies. The goal of this study is wants to see if the automatically controlled taVNSs method works well and doesn\'t cause any harm while people are doing their therapy exercises. If successful, in the future it could offer a new way to improve the recovery process movement for people with motor difficulties.

Official title: Feasibility and Tolerance of Movement-activated Auricular Vagus Nerve Stimulation in Motor Rehabilitation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2024-11-27

Completion Date

2025-10-03

Last Updated

2024-11-29

Healthy Volunteers

No

Interventions

DEVICE

Movement-evoked transcutaneous auricular Vagus nerve stimulation

Intervention requires wearing of an inertial measurement unit (IMU) sensor on an affected upper limb together with a transcutaneous auricular Vagus nerve (taVNS) stimulator on an outer ear on the contralateral side. Intervention involves IMU measurement-evoked initiation of taVNS during conventional neurorehabilitation therapy that is defined by the patient\'s doctor and therapist. Typically this is around 60 minutes/day of 50-300 repetitive upper limb movements targeting specific deficits such as flexor synergies and/or wrist, triceps or shoulder activation. taVNS intensity is calibrated at the start of every neurorehabilitation session by the patient to the maximal comfortable level with instructions to avoid pain or any serious discomfort. Patient is always accompanied by a therapist trained in the use of taVNS and the device is easy to immediately remove should any discomfort occur.

Locations (1)

Cereneo Hertenstein

Weggis, Switzerland