VNS-supplemented Motor Retraining After Stroke

October 31, 2022 updated by: George Wittenberg, University of Pittsburgh

Mechanisms of Non-invasive Vagus Nerve Stimulation Underlying Enhanced Motor Control in Humans

The goal of this study is to learn more about the connections between the brain, spinal cord, and muscles and how these connections can be strengthened after neurological injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To establish a link between the physiological mechanisms driving enhanced motor control in response to VNS, subjects will undergo progressive training on a visuomotor task that requires fine gradation of voluntary motor output to control a moving object through target boundaries. In separate groups, VNS or sham stimulation will be paired with movement when a minimal time-on-target (ToT) is achieved.

Study Type

Interventional

Enrollment (Actual)

26

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
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

INDIVIDUALS WHO HAVE HAD A STROKE:

  1. Diagnosis of first ever stroke
  2. At least 6 months after stroke onset
  3. Motor-evoked potentials in hand/arm muscles

  4. Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators.

    ALL INDIVIDUALS:

  5. Between the ages of 18 and 75 years old

Exclusion Criteria:

INDIVIDUALS WHO HAVE HAD A STROKE:

  1. Hemispatial neglect, aphasia, or cognitive impairment that would impact testing and would interfere with the ability to follow simple instructions, as judged by the investigators

    ALL INDIVIDUALS:

  2. Neurological disorder(s) influencing movement (besides stroke)
  3. History of seizure or epilepsy
  4. Metallic brain implants
  5. Bodily implants such as cardioverter defibrillators, insulin pumps, ventriculoperitoneal shunts, cochlear implants, or pacemakers
  6. Pregnant or expecting to become pregnant
  7. Difficulty maintaining alertness and/or remaining still
  8. Silicone or plastic allergy
  9. History of vestibular disorders (eg, Vertigo, Meniere's Disease, etc.)

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vagus nerve stimulation (VNS)
Stroke and control subjects will undergo 3 testing sessions and 8 training sessions in these experiments. Subjects will hold a force transducer between the index finger and thumb to control the path of an object through targets displayed on a computer monitor. VNS will be delivered when a minimum level of accuracy has been achieved.
Other: Training
Controlling movement of an object on computer screen by adjusting muscle activity.
Other: Vagus Nerve Stimulation
Recruits the auricular branch of the vagus nerve which activates brain structures that release chemicals mediating cortical plasticity.
Other Names:
  • VNS
Sham Comparator: Sham stimulation
Stroke and control subjects will undergo 3 testing sessions and 8 training sessions in these experiments. Subjects will hold a force transducer between the index finger and thumb to control the path of an object through targets displayed on a computer monitor. Sham stimulation will be delivered when a minimum level of accuracy has been achieved.
Other: Sham Stimulation
Sub-threshold stimulation that does not activate neural structures.
Other Names:
  • Sham
Other: Training
Controlling movement of an object on computer screen by adjusting muscle activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in time-on-target score.
Time Frame: 3 weeks
The score reflects the total time the object overlaps any part of targets, expressed as a percentage (0-100) of the total possible time. Thus, a score of 0 is the worst possible score, whereas, 100 is the best possible score. The primary endpoint is the change from baseline (ie, before training) in the time-on-target score.
3 weeks

Collaborators and Investigators

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

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: George F Wittenberg, MD, PhD, University of Pittsburgh

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 (Actual)

September 22, 2019

Primary Completion (Actual)

November 9, 2021

Study Completion (Actual)

November 9, 2021

Study Registration Dates

First Submitted

September 9, 2019

First Submitted That Met QC Criteria

September 11, 2019

First Posted (Actual)

September 13, 2019

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY19040394 (Aim 2)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The research team may share data with scientists at other centers for the purpose of data analysis and collaboration. Research information and data may be shared with investigators conducting other research. This information will not be identifiable.

IPD Sharing Time Frame

Information may be shared while data is being recorded, analyzed, and/or prior to publication. Data may be available for seven years after manuscripts are published.

IPD Sharing Access Criteria

Data use agreements will be established with scientists at other centers, or conducting other research, prior to any data sharing.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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