VNS-induced Corticospinal Plasticity

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Paired-Associative Stimulation (PAS); Other: Vagus Nerve Stimulation (VNS); Other: Sham Stimulation

• Registration Number: NCT04088565
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-11
• Study First Posted: 2019-09-13
• Study Start: 2019-09-22
• Primary Completion: 2021-11-09
• Study Completion: 2021-11-09
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAS+VNS	Vagus Nerve Stimulation (VNS)	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.
PAS+Sham	Paired-Associative Stimulation (PAS)	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.
PAS+Sham	Sham Stimulation	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.
PAS+VNS	Paired-Associative Stimulation (PAS)	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.

Primary Outcome Measures

Name	Time	Method
Change in size of evoked potential	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.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States