VNS-induced Corticospinal Plasticity

University of Pittsburgh26 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Stroke

Interventions

Paired-Associative Stimulation (PAS)OTHER

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

Vagus Nerve Stimulation (VNS)OTHER

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

Sham StimulationOTHER

Sub-threshold stimulation that does not activate neural structures.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.)

Locations (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Change in size of evoked potential

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.

Time frame: 1 week

Data from ClinicalTrials.gov

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