Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MicroTransponder Inc.
ClinicalTrials.gov Identifier:
NCT01669161
First received: August 15, 2012
Last updated: February 16, 2015
Last verified: February 2015
  Purpose

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 Intervention
Stroke
Device: Vivistim System
Other: Rehab Only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by MicroTransponder Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: 6-weeks ] [ Designated as safety issue: No ]
    Assessment of adverse events and serious adverse events.


Enrollment: 21
Study Start Date: February 2013
Study Completion Date: December 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669161

Locations
United Kingdom
U. Glasgow / Western Infirmary
Glasgow, Scotland, United Kingdom
Sponsors and Collaborators
MicroTransponder Inc.
Investigators
Principal Investigator: Jesse Dawson, MD U. Glasgow
  More Information

Additional Information:
No publications provided

Responsible Party: MicroTransponder Inc.
ClinicalTrials.gov Identifier: NCT01669161     History of Changes
Other Study ID Numbers: Mt-St-01
Study First Received: August 15, 2012
Last Updated: February 16, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by MicroTransponder Inc.:
Upper
Limb
Deficits
Rehabilitation
VNS

ClinicalTrials.gov processed this record on March 03, 2015