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Behavioural Intervention

tVNS, Continuous Stimulation for Prader-Willi Syndrome (VNS4PWS Trial)

Phase 3

Recruiting

Led By Deepan Singh, MD

Research Sponsored by Foundation for Prader-Willi Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 10-40 years.

Genetically proven diagnosis of PWS.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

VNS4PWS Trial Summary

This trial is testing a treatment called transcutaneous vagus nerve stimulation (tVNS) in people with PWS. The study aims to see if tVNS is effective, safe, and

Who is the study for?

This trial is for individuals aged 10-40 with Prader-Willi Syndrome (PWS) who have had at least two temper outbursts per week in the past six months. Participants must be on a stable dose of psychiatric medication and therapy regimen for three months prior, willing to share data, and have internet access. Caregivers must support data collection.Check my eligibility

What is being tested?

The study examines transcutaneous vagus nerve stimulation (tVNS) as a treatment for PWS-related temper outbursts. It will compare continuous versus intermittent tVNS to see which is more effective, safe, and acceptable.See study design

What are the potential side effects?

Potential side effects of tVNS may include discomfort at the stimulation site, headache, voice changes or hoarseness, shortness of breath, tingling or prickling sensation on the skin.

VNS4PWS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 10 and 40 years old.

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I have a genetic diagnosis of Prader-Willi Syndrome.

VNS4PWS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To determine the acceptability profile of tVNS in PWS as assessed by the rate of withdrawal from the study.

To determine the acceptability profile of tVNS in PWS as assessed by the rates of device use compliance during the study.

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

+1 more

Secondary outcome measures

To assess whether overall disease severity is improved as measured by the Change in the Clinical Global Impression of disease severity.

To assess whether there is a global improvement in behavior as assessed by the Clinical Global Impression of Improvement.

To determine the efficacy of tVNS in reducing temper outbursts in people with PWS aged 10 - 40 years over the course of the study as assessed by the irritability subscale of the Aberrant Behavior Checklist.

+8 more

Other outcome measures

Identification of responder characteristics as identified in a qualitative exit interview.

Informant and self-reported measures of acceptability as assessed by a qualitative exit interview.

To assess the change heart rate variability (HRV) in a subset of participants.

VNS4PWS Trial Design

2Treatment groups

Active Control

Group I: tVNS, Continuous StimulationActive Control1 Intervention

continuous stimulation

Group II: tVNS, Intermittent StimulationActive Control1 Intervention

28 seconds on, 32 seconds off

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Foundation for Prader-Willi ResearchLead Sponsor

13 Previous Clinical Trials

1,086 Total Patients Enrolled

12 Trials studying Prader-Willi Syndrome

906 Patients Enrolled for Prader-Willi Syndrome

RTI InternationalOTHER

189 Previous Clinical Trials

876,012 Total Patients Enrolled

2 Trials studying Prader-Willi Syndrome

30,120 Patients Enrolled for Prader-Willi Syndrome

Deepan Singh, MDPrincipal InvestigatorMaimonides Medical Center

4 Previous Clinical Trials

83 Total Patients Enrolled

3 Trials studying Prader-Willi Syndrome

63 Patients Enrolled for Prader-Willi Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it feasible for me to participate in this clinical trial?

"To be eligible for this clinical trial, potential participants must have a diagnosis of Prader-Willi syndrome and fall within the age range of 10 to 40 years old. The study has a total capacity of accepting 102 individuals with these criteria."

Answered by AI

Does this medical study have an age inclusion criterion that encompasses individuals who are 70 years of age or older?

"To be considered for this research study, individuals must fall within the age range of 10 to 40 years. It is worth noting that there are a total of 369 trials available specifically for participants under the age of 18, while there are 999 trials targeting patients above the age of 65."

Answered by AI

What are the potential risks associated with continuous transcutaneous vagus nerve stimulation (tVNS) in patients?

"Based on being a Phase 3 trial, tVNS (Continuous Stimulation) has received a safety rating of 3 by our team at Power. This signifies the availability of efficacy data and multiple rounds of safety data supporting its use."

Answered by AI

What is the overall count of participants who are signing up for this clinical study?

"To proceed with this clinical trial, we require the participation of 102 eligible patients who meet the specified inclusion criteria. Patients have the option to participate from various sites, including Maimonides Medical Center in Brooklyn, New york and Christus Children's in San Antonio, Texas."

Answered by AI

Is this medical study currently accepting new participants?

"Indeed, according to the information available on clinicaltrials.gov, this trial is currently seeking eligible candidates. The initial posting date was on January 8th, 2024 and it has been recently edited on the same day as well."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS

2024. "A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06144645.