Clinical Trials Logo
  1. Home
  2. Prader-Willi Syndrome
  3. NCT06144645

A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS — VNS4PWS  

Prader-Willi Syndrome Clinical Trial

Official title:
A Phase 3, Randomized, Double-Blind, Dose-Ranging Evaluation of Transcutaneous Vagus Nerve Stimulation (tVNS) to Reduce Temper Outbursts in People With Prader-Willi Syndrome (PWS)

Clinical Trial 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.

Clinical Trial Description

The main questions the VNS4PWS study seeks to answer are: (1) is tVNS treatment safe in people with PWS, (2) is tVNS treatment acceptable to people with PWS, and (3) is tVNS an effective treatment to reduce temper outbursts in people with PWS. Participants will wear the tVNS device daily for 4 hours over a period of 9 months. Two different doses of tVNS will be compared. During the final three months of the trial, the effect of stopping treatment will be studied. After the first year of the study, participants will have the opportunity to continue on to a 1-year open label extension period during which active tVNS treatment will be resumed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06144645
Study type Interventional
Source Foundation for Prader-Willi Research
Contact Lisa Matesvac, AuD
Phone (760)420-5878
Email VNS@fpwr.org
Status Recruiting
Phase Phase 3
Start date January 8, 2024
Completion date December 1, 2027
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05032326 - Long-term Interventional Follow-up Study of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial Phase 3
Completed NCT04526379 - Study of Emotion and Cognition Abilities of Children With PWS and Proposition of an Innovative Remediation N/A
Terminated NCT03458416 - A Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Participants With Prader-Willi Syndrome Phase 2
Completed NCT03718416 - Natural History Study of Serious Medical Events in PWS
Active, not recruiting NCT05322096 - Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome Phase 2
Completed NCT02205450 - Growth Hormone in Children Under 2 Years With Prader-Willi in Hospital of Sabadell
Terminated NCT02179151 - Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome Phase 3
Completed NCT00375089 - Characteristics of Prader-Willi Syndrome and Early-onset Morbid Obesity N/A
Completed NCT00004351 - Study of Phenotype and Genotype Correlations in Patients With Contiguous Gene Deletion Syndromes N/A
Recruiting NCT05879614 - An Open-Label Study of Oral NNZ-2591 in Prader-Willi Syndrome (PWS-001) Phase 2
Recruiting NCT05938543 - Cerebellar TMS and Satiety in Prader-Willi Syndrome N/A
Recruiting NCT03031626 - Oxygen Versus Medical Air for Treatment of CSA in Prader Will Syndrome Phase 4
Withdrawn NCT04086810 - An Open-Label Study of DCCR Tablet in Patients With PWS Phase 3
Completed NCT02629991 - Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome Phase 2
Recruiting NCT02297022 - Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome Phase 1
Not yet recruiting NCT02263781 - PREPL in Health and Disease N/A
Completed NCT00551343 - Gut Derived Hormones, Body Composition and Metabolism in Prader-Willi Syndrome N/A
Enrolling by invitation NCT03655223 - Early Check: Expanded Screening in Newborns
Recruiting NCT05939453 - Impact of Bright Light Therapy on Prader-Willi Syndrome N/A
Recruiting NCT04463316 - GROWing Up With Rare GENEtic Syndromes