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 range10 Years – 40 Years

SexALL

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.
✕. 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.

What they're measuring

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

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

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

To determine the efficacy of tVNS in reducing temper outbursts in people with PWS aged 10 - 40 years.

Timeframe: Baseline to month 9

Trial details

NCT IDNCT06144645

SponsorFoundation for Prader-Willi Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-01

View on ClinicalTrials.gov More Prader-Willi Syndrome trials

Who can participate

Age range10 Years – 40 Years

SexALL

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.
✕. 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.

What they're measuring

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

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

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

To determine the efficacy of tVNS in reducing temper outbursts in people with PWS aged 10 - 40 years.

Timeframe: Baseline to month 9