Paired Vagus Nerve Stimulation (VNS) With Rehabilitation for Upper Limb Function Improvement After Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Vivistim System; Other: Rehab Only

• Registration Number: NCT01669161
• Lead Sponsor: MicroTransponder Inc.

Brief Summary

Patients (UK only) at least 6 months post stroke, with upper limb deficits, may enroll. Patients will be randomized to one of two groups - a group implanted with a device that allows pairing VNS with rehabilitation and a group that only receives rehabilitation (no implant). Patients have two baseline evaluations, one evaluation after implant but before initiation of treatment, and then six weeks of rehabilitation or rehabilitation + VNS, followed by post acute therapy evaluations at 1, 7, and 30 days after the 6-weeks of treatment. The intent is to assess safety and provide preliminary effectiveness information for VNS for upper limb functional improvement after stroke. Implanted patients may receive longer-term treatment and follow-up after the acute study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-15
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-20
• Study Start: 2013-02
• Primary Completion: 2014-08
• Study Completion: 2014-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-13
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. History of unilateral supratentorial ischemic stroke that occurred at least 6 months prior
2. Age > 18 years and < 80 years
3. Right or left sided weakness of upper extremity

Major

Exclusion Criteria

1. Hemorrhagic stroke
2. Any deficits in language or attention that interferes with reasonable study participation
3. Presence of significant apraxia
4. Profound Sensory loss
5. Active major neurological or psychiatric diagnosis that would likely interfere with study protocol including alcohol or drug abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VNS	Vivistim System	VNS (vagus nerve stimulation) paired with rehabilitation as provided by the Vivistim System.
Rehab Only	Rehab Only	Rehabilitation only (no implant, no VNS)

Primary Outcome Measures

Name	Time	Method
Safety	6-weeks	Assessment of adverse events and serious adverse events.

Trial Locations

Locations (1)

U. Glasgow / Western Infirmary; 🇬🇧 Glasgow, Scotland, United Kingdom