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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

About this trial

This is an interventional treatment trial for Stroke focused on measuring Upper, Limb, Deficits, Rehabilitation, VNS

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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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