Vagus Nerve Stimulator for Autism and Other Developmental Disorders (NCT06259201) | Clinical Trial Compass
WithdrawnNot Applicable
Vagus Nerve Stimulator for Autism and Other Developmental Disorders
Stopped: Investigator decided to terminate the study - no participant enrolled.
United States0Started 2025-05
Plain-language 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.
Who can participate
Age range12 Years – 40 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
✕. 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.)
✕. Vagus nerve lesion, damage, or structural abnormality (e.g., lymphadenopathy, neoplasm, previous surgery), or pain (e.g., dysesthesia, neuralgia and/or cervicalgia)
✕
What they're measuring
1
Aberrant Behavior Checklist-Community (ABC-C)
Timeframe: Change measured once per month for 3, 4, or 5 months