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Pupil-Indexed Noninvasive Neuromodulation

Transcutaneous Auricular Vagus Nerve Stimulation: Motor Learning & Mechanisms

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06282406
Enrollment
110
Registered
2024-02-28
Start date
2024-06-03
Completion date
2028-08-05
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paresis

Keywords

Learning, Neurological Rehabilitation

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.

Detailed description

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.

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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Subjects will be randomized into one of 5 groups and receive the designated stimulation/sham during a training protocol designed to facilitate motor learning.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Force Control ChangePre, 1-week Post, 1-month PostSubjects will be tested on the same task used for training that involves controlling finger forces.

Countries

United States

Contacts

CONTACTMichael A Urbin, PhD
Michael.Urbin@va.gov(412) 688-6000
PRINCIPAL_INVESTIGATORMichael A. Urbin, PhD

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026