RecruitingNot ApplicableNCT06282406

Pupil-Indexed Noninvasive Neuromodulation

Transcutaneous Auricular Vagus Nerve Stimulation: Motor Learning & Mechanisms


Sponsor

VA Office of Research and Development

Enrollment

110 participants

Start Date

Jun 3, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • ALL PROSPECTIVE SUBJECTS:
  • 18-75 years of age
  • PROSPECTIVE SUBJECTS DIAGNOSED WITH STROKE:
  • Diagnosis of a single stroke resulting in hand impairment
  • Diagnosis of stroke at least six months prior to the time of participation

Exclusion Criteria12

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

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Interventions

OTHERTranscutaneous Electrical Stimulation

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

OTHERSham

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


Locations(1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

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NCT06282406


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