RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2024-01-08

Study Completion:2027-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06144645

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. Genetically proven diagnosis of PWS. 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.	1. Positive pregnancy test at screening, baseline, or at any point in the study. 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.

Inclusion Criteria

Exclusion Criteria

1. Genetically proven diagnosis of PWS.
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.

1. Positive pregnancy test at screening, baseline, or at any point in the study.
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.

Contacts and Locations

Study Contact

Lisa Matesvac, AuD

CONTACT

(760)420-5878

VNS@fpwr.org

Lisa Burnett, PhD

CONTACT

lisa.burnett@fpwr.org

Principal Investigator

Theresa Strong, PhD

PRINCIPAL_INVESTIGATOR

Foundation for Prader-Willi Research

Deepan Singh, MD

PRINCIPAL_INVESTIGATOR

Maimonides Medical Center

Lisa Burnett, PhD

STUDY_DIRECTOR

Foundation for Prader-Willi Research

Study Locations (Sites)

Stanford University

Palo Alto, California, 94304

United States

Rady Children's Hospital San Diego

San Diego, California, 92123

United States

Emory University

Atlanta, Georgia, 30322

United States

Johns Hopkins Hospital

Baltimore, Maryland, 21205

United States

Children's Mercy Kansas City

Kansas City, Missouri, 64108

United States

Montefiore Medical Center and Albert Einstein College of Medicine

Bronx, New York, 10461

United States

Maimonides Medical Center

Brooklyn, New York, 11219

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205

United States

Christus Children'S

San Antonio, Texas, 78207

United States

Collaborators and Investigators

Sponsor: Foundation for Prader-Willi Research

Theresa Strong, PhD, PRINCIPAL_INVESTIGATOR, Foundation for Prader-Willi Research
Deepan Singh, MD, PRINCIPAL_INVESTIGATOR, Maimonides Medical Center
Lisa Burnett, PhD, STUDY_DIRECTOR, Foundation for Prader-Willi Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-08

Study Completion Date2027-12-01

Study Record Updates

Study Start Date2024-01-08

Study Completion Date2027-12-01

Terms related to this study

Keywords Provided by Researchers

Prader-Willi syndrome
PWS
Prader

Additional Relevant MeSH Terms

Prader-Willi Syndrome