RECRUITING

Vagus Nerve Stimulator for Autism and Other Developmental Disorders

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Conditions

Autism Spectrum DisorderIntellectual DisabilityAutonomic Nervous SystemDevelopmental DisabilityVagus Nerve Stimulation

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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

The goal of this flexible single-subject design vagus nerve stimulation (VNS) study is to examine the behavioral, cognitive, and biorhythmic effects of VNS in children and adults with autism and developmental disabilities. The main aims are: * Pilot the creation of a profile for those who will respond to VNS with the long-term goal of designing clinical trials. * Examine the effects of VNS on a broad range of symptoms. Participants will select between 1, 2, or 3 months of daily VNS treatment and complete study visits each month.

Official Title

Vagus Nerve Stimulation for Autonomic Dysregulation in Individuals With Developmental Disorders

Quick Facts

Study Start:2024-03-01
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06259201

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:12 Years to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Children and adults aged 12-40 with intellectual and developmental disability (IDD) and/or autism spectrum disorder (ASD). Participants who are decisionally-impaired will be eligible with assent.
  2. 2. Able to tolerate wearing an Apple Watch, EEG, and sit for a neurocognitive test
  3. 3. Be on a stable dose of psychotropic medication for at least one month prior to enrollment
  4. 4. Agree not to initiate new or change existing medications or behavior intervention
  1. 1. Have an active implantable medical device (e.g., pacemaker, implanted hearing aid, etc.) or a metallic device, such as a stent, bone plate, or bone screw
  2. 2. Have a comorbid physical or psychiatric disorder which would disrupt ability to tolerate vagal stimulation or comply with study demands (e.g., insulin dependent diabetes, bipolar, etc.)
  3. 3. Vagus nerve lesion, damage, or structural abnormality (e.g., lymphadenopathy, neoplasm, previous surgery), or pain (e.g., dysesthesia, neuralgia and/or cervicalgia)
  4. 4. Current or past history of neurological disorders or trauma, including uncontrolled epilepsy and head injury.
  5. 5. Current or recent (within 12 months) participation in a clinical trial of a drug or a medical device.
  6. 6. Use of drugs (within 4 weeks) that affect the autonomic nervous system (beta blockers, beta stimulant, etc.).
  7. 7. Use of marijuana (including medical marijuana) for any indication
  8. 8. Any condition per the investigators' clinical judgment that precludes participation in the study (e.g., pregnancy).
  9. 9. Lack of capacity to consent and without a legally authorized representative (LAR) who is a parent, spouse, or an adult child.
  10. 10. Living in a residential program (e.g., group home)
  11. 11. Wards of state

Contacts and Locations

Study Contact

Helen Yoo, Ph.D.
CONTACT
718-494-5295
jhelen.yoo@opwdd.ny.gov
Eric B London, M.D.
CONTACT
naarlondon@gmail.com

Principal Investigator

Helen Yoo, Ph.D.
PRINCIPAL_INVESTIGATOR
New York State Institute for Basic Research

Study Locations (Sites)

New York State Psychiatric Institute
New York, New York, 10032
United States
New York State Institute for Basic Research
Staten Island, New York, 10314
United States

Collaborators and Investigators

Sponsor: New York State Institute for Basic Research

  • Helen Yoo, Ph.D., PRINCIPAL_INVESTIGATOR, New York State Institute for Basic Research

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 Date2024-03-01
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-03-01
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Vagus Nerve Stimulation

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder
  • Intellectual Disability
  • Autonomic Nervous System
  • Developmental Disability