Vagus Nerve Stimulation for Autonomic Dysregulation in Individuals With Developmental Disorders

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 40
Healthy Volunteers: f
View:

• 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.

• Able to tolerate wearing an Apple Watch, EEG, and sit for a neurocognitive test

• Be on a stable dose of psychotropic medication for at least one month prior to enrollment

• Agree not to initiate new or change existing medications or behavior intervention

Locations
United States
New York
New York State Psychiatric Institute
NOT_YET_RECRUITING
New York
New York State Institute for Basic Research
RECRUITING
Staten Island
Contact Information
Primary
Helen Yoo, Ph.D.
jhelen.yoo@opwdd.ny.gov
718-494-5295
Backup
Eric B London, M.D.
naarlondon@gmail.com
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 75
Treatments
Experimental: Vagus Nerve Stimulation (VNS)
Single-subject design: ABA, ABBA, or ABBBA~This study allows for a flexibility in the duration of research participation depending on one's response. The participant will be able to select one of the three design options (1, 2, or 3 months of VNS twice per day) in consultation with the study staff. That is, after the initial 1-month trial of VNS, the participant may choose to extend the VNS two more times (i.e., 1 or 2 months), for a total of 90 days.
Related Therapeutic Areas
Sponsors
Leads: New York State Institute for Basic Research
Collaborators: Boston Children's Hospital, Rutgers University

This content was sourced from clinicaltrials.gov