Paired Vagus Nerve Stimulation (VNS) With Rehabilitation for Upper Limb Function Improvement After Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Vivistim System
Rehab Only
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Upper, Limb, Deficits, Rehabilitation, VNS
Eligibility 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
Sites / Locations
- U. Glasgow / Western Infirmary
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VNS
Rehab Only
Arm Description
VNS (vagus nerve stimulation) paired with rehabilitation as provided by the Vivistim System.
Rehabilitation only (no implant, no VNS)
Outcomes
Primary Outcome Measures
Safety
Assessment of adverse events and serious adverse events.
Secondary Outcome Measures
Full Information
NCT ID
NCT01669161
First Posted
August 15, 2012
Last Updated
October 13, 2016
Sponsor
MicroTransponder Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01669161
Brief Title
Paired Vagus Nerve Stimulation (VNS) With Rehabilitation for Upper Limb Function Improvement After Stroke
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 Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MicroTransponder Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Upper, Limb, Deficits, Rehabilitation, VNS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VNS
Arm Type
Experimental
Arm Description
VNS (vagus nerve stimulation) paired with rehabilitation as provided by the Vivistim System.
Arm Title
Rehab Only
Arm Type
Active Comparator
Arm Description
Rehabilitation only (no implant, no VNS)
Intervention Type
Device
Intervention Name(s)
Vivistim System
Other Intervention Name(s)
VNS, vagus nerve stimulation, paired VNS
Intervention Description
The Vivistim System provides vagus nerve stimulation (VNS) with rehabilitation movements.
Intervention Type
Other
Intervention Name(s)
Rehab Only
Intervention Description
Rehabilitation without device implant and VNS
Primary Outcome Measure Information:
Title
Safety
Description
Assessment of adverse events and serious adverse events.
Time Frame
6-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesse Dawson, MD
Organizational Affiliation
U. Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
U. Glasgow / Western Infirmary
City
Glasgow, Scotland
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26645257
Citation
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 After Ischemic Stroke. Stroke. 2016 Jan;47(1):143-50. doi: 10.1161/STROKEAHA.115.010477. Epub 2015 Dec 8.
Results Reference
result
Links:
URL
http://my.americanheart.org/idc/groups/ahamah-public/@wcm/@sop/@scon/documents/downloadable/ucm_471670.pdf
Description
Abstract presented at the International Stroke Conference (ISC)
Learn more about this trial
Paired Vagus Nerve Stimulation (VNS) With Rehabilitation for Upper Limb Function Improvement After Stroke
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