Recruiting

Neuromodulation

Sponsor:

VA Office of Research and Development

Code:

NCT06282406

Conditions

Paresis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Transcutaneous Electrical Stimulation

Sham

Study Details

Brief summary:

Vagus nerve stimulation (VNS) is thought to activate neural pathways that release chemicals which promote plasticity and learning. Previous work has shown that the auricular branch of the vagus nerve innervates landmarks on the external ear. Work from the PI's laboratory has shown that electrical current applied to the external ear modulates physiological indexes of brain states implicated in the therapeutic effects of VNS. The broad objective of this project is to better understand physiological mechanisms modulated by auricular stimulation to support possible therapeutic effects in the form of motor learning.

Conditions

Paresis

Study ID

NCT06282406

Start date

Jun 3, 2024

Status verified date

Apr, 2026

Completion date

Aug 5, 2028

Anticipated

Primary completion date

Apr 3, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

ALL PROSPECTIVE SUBJECTS:

1. 18-75 years of age

PROSPECTIVE SUBJECTS DIAGNOSED WITH STROKE:
2. Diagnosis of a single stroke resulting in hand impairment
3. Diagnosis of stroke at least six months prior to the time of participation

Exclusion Criteria:

ALL PROSPECTIVE SUBJECTS:

1. History of vestibular disorders or dizziness
2. Difficulty maintaining alertness and/or remaining still
3. Pregnant or expecting to become pregnant
4. Diagnosis of neurological and/or musculoskeletal disorder(s) (other than stroke) that affect movement
5. Ocular disease and/or impairment in more than one eye
6. History of seizure and/or epilepsy
7. Implants, devices, or foreign objects in the brain/body that are incompatible with MRI
8. Body size that is incompatible with MRI scanner dimensions
9. Anyone already enrolled and actively participating in another greater than minimal risk study.

PROSPECTIVE SUBJECTS DIAGNOSED WITH STROKE:
10. Other impairments secondary to stroke (e.g., attention, cognition, etc.) that would interfere with the ability to understand study goals or follow simple instructions, as judged by the investigators.

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Paired, Sub-Threshold Stim

Sub-threshold stimulation paired with successful task repetitions

experimental: Paired, Supra-Threshold Stim

Supra-threshold stimulation paired with successful task repetition

experimental: Unpaired, Sub-Threshold Stim

Sub-threshold stimulation after successful task repetition

experimental: Unpaired, Supra-Threshold Stim

Supra-threshold stimulation after successful task repetition

sham comparator: Sham

No stimulation

Interventions

Transcutaneous Electrical Stimulation

Electrical pulse trains applied to the skin overlying putative sites of auricular vagal innervation.

Sham

Electrodes placed on the skin overlying putative sites of auricular vagal innervation but no current administered.

Primary outcome measure

  • Force Control Change [ Time Frame: Pre, 1-week Post, 1-month Post ]

Central Contacts and Locations

Central contacts

Locations

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Recruiting

Pittsburgh, Pennsylvania, United States, 15240

Contacts

Principal Investigator:

Michael A. Urbin, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

  • Learning
  • Neurological Rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-24.