A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS
NCT ID: NCT06144645
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
102 participants
INTERVENTIONAL
2024-01-08
2027-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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tVNS, Intermittent Stimulation
28 seconds on, 32 seconds off
tVNS, intermittent stimulation
transcutaneous vagus nerve stimulation, intermittent stimulation
tVNS, Continuous Stimulation
continuous stimulation
tVNS, continuous stimulation
transcutaneous vagus nerve stimulation, continuous stimulation
Interventions
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tVNS, intermittent stimulation
transcutaneous vagus nerve stimulation, intermittent stimulation
tVNS, continuous stimulation
transcutaneous vagus nerve stimulation, continuous stimulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age 10-40 years.
3. History in the last six months of an average of at least two temper outbursts per week.
4. Able to comply with requirements of study and provide consent or assent; If consent is to be provided by the participant's guardian, same applies to the guardian.
5. Concomitant use of psychiatric medication is allowed; participant must be on a stable dose 90 days prior to screening with no plans for dose modification during the course of the study.
6. Concomitant use of psychotherapy/counseling is allowed. Therapies for mental health or behavior challenges, including applied behavior analysis (ABA) are also allowed; however, participant must be on a stable regimen 90 days prior to screening with no plans for modification during the course of the study.
7. Living with family or in another setting with family members or staff willing to support the participant and the required data collection.
8. Agree to share tVNS patient application compliance and daily temper outburst data with the sponsor.
9. Access to cellular data or Wi-Fi.
10. Participant and caregiver speak American English as first language or are fluent in American English.
Exclusion Criteria
2. Evidence of active or recent unstable serious mental illness, including, psychosis, mania, severe depression, or suicidality.
3. Moved to present residential placement in last three months or less.
4. Likely move in residential placement during the course of the study.
5. Cardiac abnormalities including medically documented history of cardiac disease or cardiac arrhythmia, documented resting heart rate ≤ 50 beats per minute (BPM); or history of 2° type 2 or 3° heart block on electrocardiogram (ECG).
6. Evidence of clinically significant abnormalities of blood, liver, or kidney function from clinical safety laboratory assessments as determined by the Site Investigator.
7. History of blood clot, pulmonary embolism, or deep vein thrombosis.
8. Prior diagnosis of epilepsy or currently active seizures.
9. Current enrollment in the active phase of different clinical trial or interventional study.
10. Current use of hearing aids or implantable medical devices including implanted vagus nerve stimulation (iVNS) device, implanted cardiac pacemaker, implanted cardiac defibrillator, cochlear implants, cerebral shunt or cardiac implantable electrical devices.
11. Presence of dermal abnormalities at the stimulation site that would interfere with the ability of the tVNS device to function properly.
12. Presence of an allergy to titanium, titanium-iridium, thermoplastic elastomers, perfluoroethylene propylene, or polyurethane elastomers, or components of / preservatives present in the device electrode cream (Ceteareth-20, Propylene Glycol, Bentonite, Polysorbate 20, Phenoxyethanol, Ethylhexylglycerin).
13. Severe, untreated sleep apnea, as self-reported by subject or caregiver or suspected by Site Investigator.
14. Subject is, in the opinion of the Investigator, not suitable to participate in the study.
10 Years
40 Years
ALL
No
Sponsors
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RTI International
OTHER
Foundation for Prader-Willi Research
OTHER
Responsible Party
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Principal Investigators
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Theresa Strong, PhD
Role: PRINCIPAL_INVESTIGATOR
Foundation for Prader-Willi Research
Deepan Singh, MD
Role: PRINCIPAL_INVESTIGATOR
Maimonides Medical Center
Locations
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Stanford University
Palo Alto, California, United States
Rady Children's Hospital San Diego
San Diego, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Emory University
Atlanta, Georgia, United States
Rare Disease Research
Atlanta, Georgia, United States
University of Iowa
Iowa City, Iowa, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
Children's Mercy Kansas City
Kansas City, Missouri, United States
Maimonides Medical Center
Brooklyn, New York, United States
NYU Langone Health
Garden City, New York, United States
Montefiore Medical Center and Albert Einstein College of Medicine
The Bronx, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Christus Children'S
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Lynne Bird, MD
Role: primary
Ann Scheimann, MD
Role: primary
Deepan Singh, MD
Role: primary
Elizabeth Roeder, MD
Role: primary
Other Identifiers
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FPWR-VNS-R-3-01
Identifier Type: -
Identifier Source: org_study_id
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