NCT04396470

tVNS in Children With Prader-Willi Syndrome

Transcutaneous Vagus Nerve Stimulation in Children With Prader-Willi Syndrome

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 8 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prader-Willi Syndrome
• Social Behavior

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-05-01
• Completion: 2021-07-01
• First posted: 2020-05-20
• Last updated: 2021-05-06