Skip to main content
OpenTrials
Completed

NCT Number: NCT04088565

VNS-induced Corticospinal Plasticity

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms 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

Non-invasive stimulation techniques can be used to appropriately time converging inputs to induce changes in cortical output circuits of human primary motor cortex, a neuromodulatory protocol known as paired-associative stimulation (PAS). Experiments seek to examine interactions between cortical PAS and non-invasive vagus nerve stimulation (VNS) to understand the extent to which VNS amplifies cortical plasticity in humans.

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

Paired-Associative Stimulation (PAS)

Other

Simultaneous activation of connections in motor cortex via stimulation to the nerves and brain.

Other names: PAS

Vagus Nerve Stimulation (VNS)

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 size of evoked potential

    Time frame: 1 week

    The primary endpoint is the change from baseline (ie, before PAS) in the size of evoked potentials. Differences in the change between conditions (ie, PAS+VNS vs PAS+Sham) will address whether VNS drives cortical plasticity.

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.