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tVNS in Children With Prader-Willi Syndrome

NCT04396470 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2021-05-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-31
Primary Completion
2021-05-31
Completion
2021-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04396470 on ClinicalTrials.gov