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 range
12 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Aberrant Behavior Checklist-Community (ABC-C)
Timeframe: Change measured once per month for 3, 4, or 5 months
. 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)
. Current or past history of neurological disorders or trauma, including uncontrolled epilepsy and head injury.
. Current or recent (within 12 months) participation in a clinical trial of a drug or a medical device.
. Use of drugs (within 4 weeks) that affect the autonomic nervous system (beta blockers, beta stimulant, etc.).
. Use of marijuana (including medical marijuana) for any indication
. Any condition per the investigators' clinical judgment that precludes participation in the study (e.g., pregnancy).