Paired Vagus Nerve Stimulation (VNS) With Rehabilitation for Upper Limb Function Improvement After Stroke
This study is currently recruiting participants.
Verified May 2013 by MicroTransponder Inc.
Sponsor:
MicroTransponder Inc.
Information provided by (Responsible Party):
MicroTransponder Inc.
ClinicalTrials.gov Identifier:
NCT01669161
First received: August 15, 2012
Last updated: May 16, 2013
Last verified: May 2013
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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.
| Estimated Enrollment: | 20 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | March 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:
- History of unilateral supratentorial ischemic stroke that occurred at least 6 months prior
- Age > 18 years and < 80 years
- Right or left sided weakness of upper extremity
Major Exclusion Criteria:
- Hemorrhagic stroke
- Any deficits in language or attention that interferes with reasonable study participation
- Presence of significant apraxia
- Profound Sensory loss
- Active major neurological or psychiatric diagnosis that would likely interfere with study protocol including alcohol or drug abuse
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669161
Contacts
| Contact: W. Brent Tarver | 512-371-4160 | studies@microtransponder.com |
Locations
| United Kingdom | |
| U. Glasgow / Western Infirmary | Recruiting |
| Glasgow, Scotland, United Kingdom | |
Sponsors and Collaborators
MicroTransponder Inc.
More 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: | May 16, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by MicroTransponder Inc.:
|
Upper Limb Deficits Rehabilitation VNS |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 22, 2013