A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With… (NCT06144645) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS
United States102 participantsStarted 2024-01-08
Plain-language summary
The goal of the VNS4PWS clinical study is to test the efficacy, safety, and acceptability of transcutaneous vagus nerve stimulation (tVNS) treatment in people with PWS.
Who can participate
Age range
10 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
. Genetically proven diagnosis of PWS.
. Age 10-40 years.
. History in the last six months of an average of at least two temper outbursts per week.
. Able to comply with requirements of study and provide consent or assent; If consent is to be provided by the participant's guardian, same applies to the guardian.
. Concomitant use of psychiatric medication is allowed; participant must be on a stable dose 90 days prior to screening with no plans for dose modification during the course of the study.
. Concomitant use of psychotherapy/counseling is allowed. Therapies for mental health or behavior challenges, including applied behavior analysis (ABA) are also allowed; however, participant must be on a stable regimen 90 days prior to screening with no plans for modification during the course of the study.
. Living with family or in another setting with family members or staff willing to support the participant and the required data collection.
. Agree to share tVNS patient application compliance and daily temper outburst data with the sponsor.
Exclusion criteria
. Positive pregnancy test at screening, baseline, or at any point in the study.
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
To determine the safety profile and tolerability of tVNS in PWS, as assessed by the frequency, severity, and seriousness of adverse events determined during the study.
Timeframe: Through study completion, an average of 1 year
2
To determine the acceptability profile of tVNS in PWS as assessed by the rate of withdrawal from the study.
Timeframe: Through study completion, an average of 1 year
3
To determine the acceptability profile of tVNS in PWS as assessed by the rates of device use compliance during the study.
Timeframe: Through study completion, an average of 1 year
4
To determine the efficacy of tVNS in reducing temper outbursts in people with PWS aged 10 - 40 years.
. Evidence of active or recent unstable serious mental illness, including, psychosis, mania, severe depression, or suicidality.
. Moved to present residential placement in last three months or less.
. Likely move in residential placement during the course of the study.
. Cardiac abnormalities including medically documented history of cardiac disease or cardiac arrhythmia, documented resting heart rate ≤ 50 beats per minute (BPM); or history of 2° type 2 or 3° heart block on electrocardiogram (ECG).
. Evidence of clinically significant abnormalities of blood, liver, or kidney function from clinical safety laboratory assessments as determined by the Site Investigator.
. History of blood clot, pulmonary embolism, or deep vein thrombosis.
. Prior diagnosis of epilepsy or currently active seizures.