VNS During Rehabilitation for Improved Upper Limb Motor Function After Stroke

August 22, 2022 updated by: MicroTransponder Inc.

Study MT-St-02 - Stroke - A Randomized Pilot Study Assessing Vagus Nerve Stimulation (VNS) During Rehabilitation for Improved Upper Limb Motor Function After Stroke (MicroTransponder's Vivistim System)

The primary study objectives are to assess the safety and feasibility of the therapy, including the surgical intervention and stimulation, as well as to provide information on the appropriateness of the study test measures (assessments) and to provide a basis for sample size calculations for a larger, pivotal study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Texas
      • Dallas, Texas, United States
        • UT Southwestern
      • Houston, Texas, United States, 77030
        • UT Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. History of ischemic stroke that occurred at least 4 months prior to enrollment, but not more than 24 months prior
  2. Age >30 years and <80 years
  3. Right or left sided weakness of upper extremity
  4. UEFM score within designated range.
  5. At least 10 degrees of wrist extension, 10° of thumb abduction/extension, and at least 10° of extension in at least 2 additional digits

Exclusion Criteria:

  1. History of hemorrhagic stroke
  2. Any deficits in language or cognitive functioning that hinders participation, for example, (aphasia) or unable to follow 2 step commands.
  3. Significant sensory loss.
  4. Presence of ongoing dysphagia or aspiration difficulties.
  5. Active major neurological or psychiatric diagnosis that would likely interfere with study protocol including prior history of brain lesions (including dementia, etc.), and current alcohol abuse, drug abuse, or epilepsy.
  6. Subject receiving any therapy (medication or otherwise) at study entry that would interfere with VNS (e.g. drugs that interfere with neurotransmitter mechanisms). Additionally, no psychoactive medications - including nicotine - may be used during the acute study.
  7. Prior injury to vagus nerve - either bilateral or unilateral (e.g., injury during carotid endarterectomy)
  8. Severe depression
  9. Not considered candidate for a device implant surgery (history of adverse reactions to anesthetics, poor surgical candidate in surgeon's opinion, etc.)
  10. Any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug
  11. Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse)
  12. Pregnant or plan on becoming pregnant or breastfeeding during the study period
  13. Currently require, or likely to require, diathermy during the study duration
  14. Any health problem requiring surveillance with MRI imaging
  15. Active rehabilitation within 4-weeks prior to therapy
  16. Botox injections or any other non-study active rehabilitation of the upper extremity 4-weeks prior to and during therapy
  17. Severe spasticity of the upper limb

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vagus Nerve Stimulation (VNS) + Rehabilitation (1)
This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.
Device: Vagus Nerve Stimulation (VNS)
Other Names:
  • VNS
Active Comparator: Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator
This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.
Device: Vagus Nerve Stimulation (VNS)
Other Names:
  • VNS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Upper Extremity Fugl-Meyer (UEFM)
Time Frame: 6-weeks
Measurement of impairment, minimum value 0, maximum value 66, higher score means a better outcome. Subscales are summed.
6-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Wolf Motor Function Test Functional Assessment (WMFT)
Time Frame: 6-weeks
Measurement of upper limb function/mobility. For Functional Assessment - minimum is 0 and maximum is 3. A higher score means a better outcome.
6-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MicroTransponder Inc.

Investigators

  • Principal Investigator: Patty Smith, Ph.D., UT Southwestern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

September 15, 2014

First Submitted That Met QC Criteria

September 15, 2014

First Posted (Estimate)

September 17, 2014

Study Record Updates

Last Update Posted (Actual)

September 15, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-St-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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