- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04396470
tVNS in Children With Prader-Willi Syndrome
May 3, 2021 updated by: Karen Parker, Stanford University
Transcutaneous Vagus Nerve Stimulation in Children With Prader-Willi Syndrome
The purpose of the current project is to test the impact of transcutaneous vagus nerve stimulation (tVNS) on social ability in children with Prader-Willi Syndrome (PWS).
Social ability and blood neuropeptides associated with social functioning will be measured before and after engagement in 12 weeks of tVNS therapy.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
- Phase 1
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.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- (1) be between the ages of 8-14 years; (2) have a confirmed diagnosis of PWS by genetic testing; (3) be minimally verbal and able to sit at a table to complete cognitive and behavioral testing; (4) be willing to provide blood samples; and (5) be willing to engage in a 16-week study period (baseline to intervention follow-up).
Exclusion Criteria:
- (1) currently taking oxytocin and/or arginine vasopressin or related analogs and (2) have a DSM-5 diagnosis of any severe mental or behavioral disorder (e.g. schizophrenia, bipolar disorder, conduct or oppositional defiant disorder) that significantly impacts daily functioning.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: tVNS treatment
|
Participants will be randomized to either the tVNS treatment condition or the sham tVNS (placebo) condition.
An identical non-invasive tVNS device will be used in both groups.
In the active condition, the device is placed on the external earlobe (tragus), which directly stimulates the vagus nerve.
In the sham condition, the device is placed on the external earlobe, providing the same sensations as in the treatment condition, but no stimulation to the vagus nerve.
Intervention period: Participants will use the device 1-hr per day for 12 weeks per manufacturer's instructions.
|
Sham Comparator: tVNS sham treatment
|
Participants will be randomized to either the tVNS treatment condition or the sham tVNS (placebo) condition.
An identical non-invasive tVNS device will be used in both groups.
In the active condition, the device is placed on the external earlobe (tragus), which directly stimulates the vagus nerve.
In the sham condition, the device is placed on the external earlobe, providing the same sensations as in the treatment condition, but no stimulation to the vagus nerve.
Intervention period: Participants will use the device 1-hr per day for 12 weeks per manufacturer's instructions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social Responsiveness Scale, 2nd Edition (SRS-2)
Time Frame: pre-post 12 week intervention period
|
Identifies the presence and severity of social impairments in child participants by parent report
|
pre-post 12 week intervention period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start (Anticipated)
July 1, 2020
Primary Completion (Anticipated)
May 1, 2021
Study Completion (Anticipated)
July 1, 2021
Study Registration Dates
First Submitted
May 15, 2020
First Submitted That Met QC Criteria
May 15, 2020
First Posted (Actual)
May 20, 2020
Study Record Updates
Last Update Posted (Actual)
May 6, 2021
Last Update Submitted That Met QC Criteria
May 3, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Disease
- Congenital Abnormalities
- Overnutrition
- Nutrition Disorders
- Genetic Diseases, Inborn
- Intellectual Disability
- Abnormalities, Multiple
- Chromosome Disorders
- Obesity
- Syndrome
- Prader-Willi Syndrome
Other Study ID Numbers
- 55936
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prader-Willi Syndrome
-
University Hospital, ToulouseCompletedPrader Willi SyndromeFrance
-
University of FloridaNational Institutes of Health (NIH)Completed
-
Samsung Medical CenterCompletedObesity | Prader Willi Syndrome
-
Duke UniversityCanadian Institutes of Health Research (CIHR); National Institutes of Health... and other collaboratorsCompleted
-
California State University, FullertonUniversity of FloridaUnknownFamily-based Intervention for Youth With Prader-Willi Syndrome: The Active Play at Home Study (APAH)Childhood Obesity | Prader Willi SyndromeUnited States
-
SanionaCompletedConfirmed Genetic Diagnosis of Prader-Willi SyndromeCzechia, Hungary
-
Weill Medical College of Cornell UniversityNational Institutes of Health (NIH); PWSAUSATerminatedPrader-willi SyndromeUnited States
-
Ferring PharmaceuticalsCompletedHyperphagia in Prader-Willi SyndromeUnited States
-
University of FloridaFoundation for Prader-Willi ResearchCompleted
-
ACADIA Pharmaceuticals Inc.RecruitingHyperphagia in Prader-Willi SyndromeUnited States, Canada
Clinical Trials on tVNS
-
Shanghai Mental Health CenterEnrolling by invitation
-
Foundation for Prader-Willi ResearchRTI InternationalRecruitingPrader-Willi SyndromeUnited States
-
Fondazione Toscana Gabriele MonasterioAzienda Ospedaliera Città della Salute e della Scienza di TorinoNot yet recruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Midrange Ejection FractionItaly
-
University of FloridaCompletedStress, Psychological | Sleep | Vagus Nerve Stimulation | Mindfulness | Transcutaneous Electric Nerve StimulationUnited States
-
Istituti Clinici Scientifici Maugeri SpARecruitingHeart Failure With Preserved Ejection Fraction | Heart Failure With Midrange Ejection FractionItaly
-
University of California, Los AngelesUniversity of OklahomaRecruitingAtrial FibrillationUnited States
-
University GhentCompleted
-
Krankenhaus HetzelstiftJohannes Gutenberg University Mainz; Deutsche Stiftung für HerzforschungRecruiting
-
Massachusetts General HospitalNational Institutes of Health (NIH)Recruiting
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH)RecruitingMajor Depressive DisorderUnited States