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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MicroTransponder Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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