WithdrawnPhase 1/2

tVNS in Children With Prader-Willi Syndrome

Stopped: No funding received

0Started 2020-07

Plain-language 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 neuropeptides associated with social functioning will be measured before and after engagement in 12 weeks of tVNS therapy.

Who can participate

Age range8 Years – 14 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Social Responsiveness Scale, 2nd Edition (SRS-2)

Timeframe: pre-post 12 week intervention period

Trial details

NCT IDNCT04396470

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05

View on ClinicalTrials.gov More Prader-Willi Syndrome trials