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OpenTrials
Completed

NCT Number: NCT01669161

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

U. Glasgow / Western Infirmary

Glasgow, Scotland, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vivistim System

Device

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

Other names: VNS, vagus nerve stimulation, paired VNS

Rehab Only

Other

Rehabilitation without device implant and VNS

Primary outcomes

  1. Safety

    Time frame: 6-weeks

    Assessment of adverse events and serious adverse events.

Sponsors and collaborators

Lead sponsor

MicroTransponder Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 20, 2012
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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