NCT06282406 Pupil-Indexed Noninvasive Neuromodulation
| NCT ID | NCT06282406 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Paresis |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-06-03 |
| Primary Completion | 2028-04-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2024-06-03 with a primary completion date of 2028-04-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Michael A. Urbin, PhD
PRINCIPAL INVESTIGATOR
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Frequently Asked Questions
Who can join the NCT06282406 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Paresis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06282406 currently recruiting?
Yes, NCT06282406 is actively recruiting participants. Contact the research team at Michael.Urbin@va.gov for enrollment information.
Where is the NCT06282406 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT06282406 clinical trial?
NCT06282406 is sponsored by VA Office of Research and Development. The principal investigator is Michael A. Urbin, PhD at VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA. The trial plans to enroll 110 participants.