RECRUITING

Pupil-Indexed Noninvasive Neuromodulation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Transcutaneous Auricular Vagus Nerve Stimulation: Motor Learning & Mechanisms

Quick Facts

Study Start:2024-06-03
Study Completion:2028-08-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06282406

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18-75 years of age
  2. 2. Diagnosis of a single stroke resulting in hand impairment
  3. 3. Diagnosis of stroke at least six months prior to the time of participation
  1. 1. History of vestibular disorders or dizziness
  2. 2. Difficulty maintaining alertness and/or remaining still
  3. 3. Pregnant or expecting to become pregnant
  4. 4. Diagnosis of neurological and/or musculoskeletal disorder(s) (other than stroke) that affect movement
  5. 5. Ocular disease and/or impairment in more than one eye
  6. 6. History of seizure and/or epilepsy
  7. 7. Implants, devices, or foreign objects in the brain/body that are incompatible with MRI
  8. 8. Body size that is incompatible with MRI scanner dimensions
  9. 9. Anyone already enrolled and actively participating in another greater than minimal risk study.
  10. 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.

Contacts and Locations

Study Contact

Michael A Urbin, PhD
CONTACT
(412) 688-6000
Michael.Urbin@va.gov
Brad E Dicianno, MD MS
CONTACT
(412) 822-3700
Brad.Dicianno@va.gov

Principal Investigator

Michael A. Urbin, PhD
PRINCIPAL_INVESTIGATOR
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study Locations (Sites)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Michael A. Urbin, PhD, PRINCIPAL_INVESTIGATOR, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-03
Study Completion Date2028-08-05

Study Record Updates

Study Start Date2024-06-03
Study Completion Date2028-08-05

Terms related to this study

Keywords Provided by Researchers

  • Learning
  • Neurological Rehabilitation

Additional Relevant MeSH Terms

  • Paresis