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

Stroke Clinical Trial

Official title:

A Proof-of-Concept Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Rehabilitation for Improved Upper Limb Function After Stroke (MicroTransponder's Vivistim System)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669161
• Other study ID #: Mt-St-01
• Status: Completed
• Phase: N/A
• First received: August 15, 2012
• Last updated: October 13, 2016
• Start date: February 2013
• Est. completion date: December 2014

Study information

• Verified date: October 2016
• Source: MicroTransponder Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Major 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Vivistim System
The Vivistim System provides vagus nerve stimulation (VNS) with rehabilitation movements.

Other:
• Rehab Only
Rehabilitation without device implant and VNS

Locations

Country	Name	City	State
United Kingdom	U. Glasgow / Western Infirmary	Glasgow, Scotland

Sponsors (1)

Lead Sponsor	Collaborator
MicroTransponder Inc.

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Dawson J, Pierce D, Dixit A, Kimberley TJ, Robertson M, Tarver B, Hilmi O, McLean J, Forbes K, Kilgard MP, Rennaker RL, Cramer SC, Walters M, Engineer N. Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation Af — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Assessment of adverse events and serious adverse events.	6-weeks	No

External Links

•   Abstract presented at the International Stroke Conference (ISC)
•   Article discussing study results