tVNS in Children With Prader-Willi Syndrome

Prader-Willi Syndrome Clinical Trial

Official title:

Transcutaneous Vagus Nerve Stimulation in Children With Prader-Willi Syndrome

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04396470
• Other study ID #: 55936
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: July 2020
• Est. completion date: July 2021

Study information

• Verified date: May 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prader-Willi Syndrome
• Social Behavior
• Syndrome

Intervention

Device:
• tVNS
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Social Responsiveness Scale, 2nd Edition (SRS-2)	Identifies the presence and severity of social impairments in child participants by parent report	pre-post 12 week intervention period