VNS-induced Corticospinal Plasticity

University of Pittsburgh

Status: Completed

Conditions: Stroke

Treatments: Other: Sham Stimulation; Other: Paired-Associative Stimulation (PAS); Other: Vagus Nerve Stimulation (VNS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04088565

STUDY19040394 (Aim 1)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

PAS+VNS

Experimental group

Description:

Paired-associative stimulation (PAS) targeting primary motor cortex will be administered with VNS in individuals with hemiparesis secondary to stroke and neurologically-intact, age-matched controls.

Treatment:

Other: Vagus Nerve Stimulation (VNS)

Other: Paired-Associative Stimulation (PAS)

PAS+Sham

Sham Comparator group

Description:

Paired-associative stimulation (PAS) targeting primary motor cortex will be administered with sham stimulation in individuals with hemiparesis secondary to stroke and neurologically-intact, age-matched controls.

Treatment:

Other: Paired-Associative Stimulation (PAS)

Other: Sham Stimulation