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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01669161
Recruitment Status : Completed
First Posted : August 20, 2012
Last Update Posted : October 17, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stroke Device: Vivistim System Other: Rehab Only Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : February 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: VNS
VNS (vagus nerve stimulation) paired with rehabilitation as provided by the Vivistim System.
Device: Vivistim System
The Vivistim System provides vagus nerve stimulation (VNS) with rehabilitation movements.
Other Name: VNS, vagus nerve stimulation, paired VNS

Active Comparator: Rehab Only
Rehabilitation only (no implant, no VNS)
Other: Rehab Only
Rehabilitation without device implant and VNS

Primary Outcome Measures :
  1. Safety [ Time Frame: 6-weeks ]
    Assessment of adverse events and serious adverse events.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669161

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United Kingdom
U. Glasgow / Western Infirmary
Glasgow, Scotland, United Kingdom
Sponsors and Collaborators
MicroTransponder Inc.
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Principal Investigator: Jesse Dawson, MD U. Glasgow
Additional Information:
Publications of Results:
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Responsible Party: MicroTransponder Inc.
ClinicalTrials.gov Identifier: NCT01669161    
Other Study ID Numbers: Mt-St-01
First Posted: August 20, 2012    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by MicroTransponder Inc.:
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases