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

PHASE3RecruitingINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

January 8, 2024

Primary Completion Date

December 1, 2026

Study Completion Date

December 1, 2027

Conditions
Prader-Willi Syndrome
Interventions
DEVICE

tVNS, intermittent stimulation

transcutaneous vagus nerve stimulation, intermittent stimulation

DEVICE

tVNS, continuous stimulation

transcutaneous vagus nerve stimulation, continuous stimulation

Trial Locations (17)

10461

RECRUITING

Montefiore Medical Center and Albert Einstein College of Medicine, The Bronx

11219

RECRUITING

Maimonides Medical Center, Brooklyn

11530

RECRUITING

NYU Langone Health, Garden City

21205

RECRUITING

Johns Hopkins Hospital, Baltimore

22908

RECRUITING

University of Virginia, Charlottesville

30322

RECRUITING

Emory University, Atlanta

30329

RECRUITING

Rare Disease Research, Atlanta

37203

RECRUITING

Vanderbilt University Medical Center, Nashville

43205

RECRUITING

Nationwide Children's Hospital, Columbus

44106

RECRUITING

University Hospitals Cleveland Medical Center, Cleveland

55454

RECRUITING

University of Minnesota, Minneapolis

64108

RECRUITING

Children's Mercy Kansas City, Kansas City

78207

RECRUITING

Christus Children'S, San Antonio

80045

RECRUITING

Children's Hospital Colorado, Aurora

84108

RECRUITING

University of Utah, Salt Lake City

92123

RECRUITING

Rady Children's Hospital San Diego, San Diego

94304

RECRUITING

Stanford University, Palo Alto

All Listed Sponsors
collaborator

RTI International

OTHER

lead

Foundation for Prader-Willi Research

OTHER