ACTIVE_NOT_RECRUITING

Understanding the Effects of Transauricular Vagus Nerve Stimulation on Neural Networks and Autonomic Nervous System

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Healthy Volunteersvagal nerve stimulationhealthy subjectsbiomarkers

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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

This trial aims to perform an exploratory, mechanistic, randomized double-blind sham-control trial in healthy participants to assess the physiologic effects of a single 60 minutes session of bilateral taVNS, on neural networks and autonomic function.

Official Title

Understanding the Effects of Non-invasive Transauricular Vagus Nerve Stimulation (taVNS) on Neural Networks and Autonomic Nervous System: a Randomized Double-blind Sham-control Mechanistic Trial in Healthy Participants

Quick Facts

Study Start:2023-04-26
Study Completion:2026-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05801809

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 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Able to provide informed consent to participate in the study.
  2. 2. Subject is older than 18 years.
  3. 3. Subjects should be naive to the stimulation (taVNS)
  1. 1. Pregnancy.
  2. 2. Subjects who have had a neuropsychiatric or a cardiac disorder diagnosis and have received treatment and chronic medication in the past six months, or who have functional deficits as a result.
  3. 3. History of alcohol or drug abuse within the past 6 months as self-reported.
  4. 4. Presence of the following contraindication to transauricular vagus nerve stimulation
  5. 1. Ferromagnetic metal in the head and in the cranium (e.g., plates or pins, bullets, shrapnel)
  6. 2. Implanted cranial electronic medical devices (e.g., cochlear implants)
  7. 3. Implanted cardiac devices (e.g., pacemaker)
  8. 5. Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure, or chronic obstructive pulmonary disease).
  9. 6. Uncontrolled epilepsy, as defined by previous clinical seizures in the past 3 months in patients with treatment for epilepsy.
  10. 7. Suffering from severe depression (as defined by a score of \>30 in the Beck Depression Inventory).

Contacts and Locations

Principal Investigator

Felipe Fregni, MD, PhD, MPH
PRINCIPAL_INVESTIGATOR
Spaulding Rehabilitation Hospital/Harvard Medical School

Study Locations (Sites)

Spaulding Hospital Cambridge
Cambridge, Massachusetts, 02138
United States

Collaborators and Investigators

Sponsor: Spaulding Rehabilitation Hospital

  • Felipe Fregni, MD, PhD, MPH, PRINCIPAL_INVESTIGATOR, Spaulding Rehabilitation Hospital/Harvard Medical School

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 Date2023-04-26
Study Completion Date2026-03-01

Study Record Updates

Study Start Date2023-04-26
Study Completion Date2026-03-01

Terms related to this study

Keywords Provided by Researchers

  • vagal nerve stimulation
  • healthy subjects
  • biomarkers

Additional Relevant MeSH Terms

  • Healthy Volunteers