Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06144645
Status:
RECRUITING
Last Update Posted:
2024-01-10
First Post:
2023-10-16
Brief Title:
A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS
Sponsor:
Foundation for Prader-Willi Research
Organization:
Foundation for Prader-Willi Research
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VNS4PWS
Brief 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
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None