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

NCT06144645 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

tVNS, intermittent stimulation

transcutaneous vagus nerve stimulation, intermittent stimulation

DEVICE

tVNS, continuous stimulation

transcutaneous vagus nerve stimulation, continuous stimulation

Sponsors & Collaborators

  • RTI International

    collaborator OTHER

  • Foundation for Prader-Willi Research

    lead OTHER

Principal Investigators

  • Theresa Strong, PhD · Foundation for Prader-Willi Research

  • Deepan Singh, MD · Maimonides Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-08
Primary Completion
2027-04-01
Completion
2027-04-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06144645 on ClinicalTrials.gov