Impact of VNS With Rehab on Gait Post-Stroke

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
Stroke is a major cause of disability worldwide and currently there is a lack ofeffective treatments to improve functional capacity of patients with long‐termdisability. Vagus Nerve Stimulation (VNS) is FDA‐approved for rehabilitation of upperlimb deficits in patient with stroke. The device (including Vagus nerve electrodes andchest generator) is permanently implanted prior to the beginning of rehabilitation asstandard of care. It is activated by patients and physical therapists during a period of4.5 months of in‐clinic and home therapy. However, so far there have been no approvedneuromodulation treatments to improve lower limb functions and gait, which are key forpatients' quality of life and their ability to integrate with work and social cycles.This project will evaluate the impact of VNS on lower limb functions as measured byclinical and laboratory‐based analyses of gait in stroke survivors. Patients with bothupper and lower limb deficits will be included in this project. After the completion ofthe standard upper limb VNS‐rehabilitation protocol, patients will be double‐blindlyrandomized into 2 groups: a) lower limbs and gait rehabilitation with VNS ON for theduration of therapy; b) lower limbs and gait rehabilitation with VNS OFF.Based on prior experience with upper limb deficits, we hypothesize that rehabilitationtherapy coupled with VNS neuromodulation will elicit functional improvements in lowerlimb deficits and gait.
Epistemonikos ID: 261c734f55fdc327835b76020c0d96fd40e0430c
First added on: Jun 12, 2026