Study protocol for a pivotal randomised study assessing vagus nerve stimulation during rehabilitation for improved...

Area of Science:

• Neuroscience
• Rehabilitation Medicine
• Biomedical Engineering

Background:

• Vagus nerve stimulation (VNS) paired with motor tasks enhances motor recovery in stroke models.
• Pilot studies suggest VNS combined with rehabilitation is safe and improves upper limb function post-stroke.
• Preliminary data support further investigation in a larger clinical trial.

Purpose of the Study:

• To evaluate the safety and efficacy of VNS paired with upper limb rehabilitation in stroke survivors.
• To compare active VNS with control VNS in improving motor function.
• To assess the long-term effects of VNS-rehabilitation therapy.

Main Methods:

• A multi-site, double-blinded, randomized trial (VNS-REHAB) involving up to 120 participants.
• Participants received VNS device implantation and were randomized to active (0.8 mA) or control (0.0 mA) VNS.
• A six-week in-clinic therapy regimen followed by three months of home-based therapy, with VNS delivered during movement repetitions.

Main Results:

• The primary endpoint is the change in Fugl-Meyer assessment-upper extremity scores after six weeks of in-clinic therapy.
• Secondary endpoints will also be assessed to evaluate functional improvements.
• Safety will be monitored through adverse events and device complications.

Conclusions:

• This pivotal trial will determine the safety and effectiveness of VNS combined with rehabilitation for post-stroke arm function improvement.
• Results will inform clinical practice regarding VNS as a therapeutic option for stroke recovery.
• The study is registered on ClinicalTrials.gov (NCT03131960).