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NCT03101826 · ClinicalTrials.gov registry record · NA
Optimizing the Social Engagement System in Prader-Willi Syndrome: Insights From the Polyvagal Theory
A NA study, sponsored by Indiana University.
- Terminated
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT03101826 is a NA study that was terminated before completion, run by Indiana University. The registered enrollment target is 5 participants.
The verdict
NCT03101826, a NA study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
The Polyvagal Theory focuses on how function and structure changed in the vertebrate autonomic nervous system during evolution. The theory is named for the vagus, a major cranial nerve that regulates bodily state. As a function of evolution, humans and other mammals have a "new" vagal pathway that links the regulation of bodily state to the control of the muscles of the face and head including the middle ear muscles. These pathways regulating body state, facial gesture, listening (i.e., middle ear muscles), and vocal communication collectively function as a Social Engagement System (SES). Because the Social Engagement System is an integrated system, interventions influencing one component of this system (e.g., middle ear muscles) may impact on the other components. Individuals with Prader-Willi Syndrome (PWS) exhibit many behaviors that are consistent with a compromised Social Engagement System. Atypical function of the Social Engagement System results in problems associated with state regulation (e.g., impulsivity, tantrums, and difficulty with change in routine), ingestion (e.g., difficulties in sucking at birth, hyperphagia), coordination of suck/swallow/breathe, intonation of vocalizations, auditory processing and hypersensitivity, and socialization. We propose to confirm that several features of the behavioral phenotype of PWS may be explained within the context of a dysfunctional SES (Specific Aim I), which may be partially rehabilitated via an intervention designed as a 'neural exercise' of the SES (Specific Aim II). Specific Aims: Aim I: To demonstrate that children with PWS have atypical regulation of the SES. We hypothesize these effects will be manifested by dampened vagal regulation of the heart (low parasympathetic tone); poor middle ear muscle regulation resulting in auditory hypersensitivities and poor auditory processing; lack of voice intonation (prosody), and difficulties in accurately detecting the emotions of others. Aim II: To demonstrate th
Interventions
- BEHAVIORAL Listening Project Protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2017-11-01 |
| Est. Completion | 2023-03-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03101826
The ClinicalTrials.gov registry entry for NCT03101826 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Listening Project Protocol is the first listed.
NCT03101826 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03101826 about?
NCT03101826 is a clinical study titled "Optimizing the Social Engagement System in Prader-Willi Syndrome: Insights From the Polyvagal Theory". The Polyvagal Theory focuses on how function and structure changed in the vertebrate autonomic nervous system during evolution. The theory is named for the vagus, a major cranial nerve that regulates bodily state. As a function of evolution, humans and other mammals have a "new" vagal pathway that l...
What is the current status of trial NCT03101826?
This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2017-11-01. Estimated completion is 2023-03-08.
What interventions are being tested in trial NCT03101826?
The interventions under investigation include: Listening Project Protocol (BEHAVIORAL).
Who is sponsoring clinical trial NCT03101826?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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