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NCT Number: NCT06282406

Pupil-Indexed Noninvasive Neuromodulation

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location status: Recruiting

Location contact

Camona Beth

CONTACT

(412) 822-3700

Michael A. Urbin, PhD

PRINCIPAL_INVESTIGATOR

Nikitha Deepak, MS BS

CONTACT

[email protected]

412-822-3669

About this study

Existing evidence supports the use of VNS to enhance the effects of traditional therapy on impairments due to neurological injury. It is known that the vagus nerve forms contacts with neuromodulatory nuclei in the brainstem that release of chemicals shown to be critically involved in attentional control and memory formation. It is also known that the auricular branch of the vagus nerve innervates portions of the external ear providing a possible means to engage similar neural pathways noninvasively via transcutaneous auricular vagus nerve stimulation (taVNS). Recent work from the PI's laboratory shows that electrical current applied to landmarks on the external ear elicits transient effects on pupil dilation, an established physiological index of brain states that support learning. Given the ability to engage the biomarker, the investigators aim to further investigate physiological mechanisms modulated by taVNS and possible effects on learning.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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.

Treatment and study plan

Transcutaneous electrical stimulation

Other

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

SHAM

Other

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

Primary outcomes

  1. Force Control Change

    Time frame: Pre, 1-week Post, 1-month Post

    Subjects will be tested on the same task used for training that involves controlling finger forces.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael A Urbin, PhD

CONTACT

[email protected]

(412) 688-6000

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Transcutaneous Auricular Vagus Nerve Stimulation: Motor Learning & Mechanisms

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 28, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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