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

October 13, 2016 updated by: MicroTransponder Inc.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, Scotland, United Kingdom
        • U. Glasgow / Western Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 6-weeks
Assessment of adverse events and serious adverse events.
6-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MicroTransponder Inc.

Investigators

  • Principal Investigator: Jesse Dawson, MD, U. Glasgow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

August 15, 2012

First Submitted That Met QC Criteria

August 16, 2012

First Posted (ESTIMATE)

August 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 17, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mt-St-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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