tVNS in Children With Prader-Willi Syndrome

Phase 1

Withdrawn

• Conditions: Social Behavior; Prader-Willi Syndrome
• Interventions: Device: tVNS

• Registration Number: NCT04396470
• Lead Sponsor: Stanford University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-15
• Study First Submitted QC: 2020-05-15
• Study First Posted: 2020-05-20
• Study Start: 2020-07
• Status Verified: 2021-05
• Primary Completion: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-06
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tVNS sham treatment	tVNS	-
tVNS treatment	tVNS	-

Primary Outcome Measures

Name	Time	Method
Social Responsiveness Scale, 2nd Edition (SRS-2)	pre-post 12 week intervention period	Identifies the presence and severity of social impairments in child participants by parent report