Status:
WITHDRAWN
tVNS in Children With Prader-Willi Syndrome
Lead Sponsor:
Stanford University
Conditions:
Prader-Willi Syndrome
Social Behavior
Eligibility:
All Genders
8-14 years
Phase:
PHASE1
PHASE2
Brief Summary
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 neuro...
Eligibility Criteria
Inclusion
- (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
- (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.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04396470
Start Date
July 1 2020
End Date
July 1 2021
Last Update
May 6 2021
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