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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tVNS treatment | Experimental |
| |
| tVNS sham treatment | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tVNS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D011218 | Prader-Willi Syndrome |
| D012919 | Social Behavior |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D000096803 | Imprinting Disorders |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |