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Completed

NCT Number: NCT04088578

VNS-supplemented Motor Retraining After Stroke

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

INDIVIDUALS WHO HAVE HAD A STROKE:

  • Diagnosis of first ever stroke
  • At least 6 months after stroke onset
  • Motor-evoked potentials in hand/arm muscles
  • Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators.

ALL INDIVIDUALS:

  • Between the ages of 18 and 75 years old

Exclusion criteria

INDIVIDUALS WHO HAVE HAD A STROKE:

  • 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:

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

Treatment and study plan

Training

Other

Controlling movement of an object on computer screen by adjusting muscle activity.

Vagus nerve stimulation

Other

Recruits the auricular branch of the vagus nerve which activates brain structures that release chemicals mediating cortical plasticity.

Other names: VNS

Sham stimulation

Other

Sub-threshold stimulation that does not activate neural structures.

Other names: Sham

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 13, 2019
Registry last updated
Nov 1, 2022

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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