NCT01669161

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 20, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

1.5 years

First QC Date

August 15, 2012

Last Update Submit

October 13, 2016

Conditions

Stroke

Keywords

UpperLimbDeficitsRehabilitationVNS

Outcome Measures

Primary Outcomes (1)

  • Safety

    Assessment of adverse events and serious adverse events.

    6-weeks

Study Arms (2)

VNS

EXPERIMENTAL

VNS (vagus nerve stimulation) paired with rehabilitation as provided by the Vivistim System.

Device: Vivistim System

Rehab Only

ACTIVE COMPARATOR

Rehabilitation only (no implant, no VNS)

Other: Rehab Only

Interventions

Vivistim SystemDEVICE

The Vivistim System provides vagus nerve stimulation (VNS) with rehabilitation movements.

Also known as: VNS, vagus nerve stimulation, paired VNS
VNS
Rehab OnlyOTHER

Rehabilitation without device implant and VNS

Rehab Only

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U. Glasgow / Western Infirmary

Glasgow, Scotland, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 26645257RESULT

Related Links

MeSH Terms

Conditions

Stroke

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeutics

Study Officials

  • Jesse Dawson, MD

    U. Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2012

First Posted

August 20, 2012

Study Start

February 1, 2013

Primary Completion

August 1, 2014

Study Completion

December 1, 2014

Last Updated

October 17, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)