Clinical Trial: Optimizing the Social Engagement System in Prader-Willi Syndrome: Insights From the Polyvagal Theory

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Optimizing the Social Engagement System in Prader-Willi Syndrome: Insights From the Polyvagal Theory

Brief 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 regula

Detailed Summary:
Sponsor: Indiana University

Current Primary Outcome: Effect of Intervention on Autonomic regulation [ Time Frame: Change from 1 week pre-intervention RSA to 1 month post-intervention ]

Respiratory sinus arrhythmia (RSA)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Effect of Intervention on Heart period [ Time Frame: Change from 1 week pre-intervention heart period to 1 month post-intervention ]
    heart period
  • Effect of Intervention on Auditory processing [ Time Frame: Change from 1 week pre-intervention Filtered Words to 1 month post-intervention ]
    Filtered Words subtest of SCAN
  • Effect of Intervention on Auditory processing [ Time Frame: Change from 1 week pre-intervention Competing Words to 1 month post-intervention ]
    Competing Words subtest of SCAN
  • Effect of Intervention on Sensory Sensitivities [ Time Frame: Change from 1 week pre-intervention BBC Sensory Scales to 1 month post-intervention ]
    BBC Sensory Scales (questionnaire)
  • Effect of Intervention on Latency to Affect recognition [ Time Frame: Change from 1 week pre-intervention DARE (latency) to 1 month post-intervention ]
    Dynamic Affect Recognition Evaluation (DARE) - latency
  • Effect of Intervention on Accuracy of Affect recognition [ Time Frame: Change from 1 week pre-intervention DARE (accuracy) to 1 month post-intervention ]
    Dynamic Affect Recognition Evaluation (DARE) - accuracy
  • Effect of Intervention on Prosody [ Time Frame: Change from 1 week pre-intervention Prosody to 1 month post-intervention ]
    Analyses of vocal recordings
  • Effect of Intervention on Disruptive Behavior [ Time Frame: Change from 1 week pre-intervention DBC to 1 month post-intervention ]
    Developmental Behavior Checklist (DBC) (questionnaire)
  • Effect of Intervention on Social behavior [ Time Frame: Change from 1 week post-intervention LPP to 1 month post-intervention ]
    Listening Project Parent (LPP) Questionnaire
  • Effect of Intervention on Oxytocin [ Time Frame: Change from 1 week pre-intervention oxytocin to 1 month post-intervention ]
    oxytocin levels derived from salivary sample
  • Effect of Intervention on Vasopressin [ Time Frame: Change from 1 week pre-intervention vasopressin to 1 month post-intervention ]
    vasopressin levels derived from salivary sample


Original Secondary Outcome: Same as current

Information By: Indiana University

Dates:
Date Received: March 23, 2017
Date Started: May 2017
Date Completion: May 2019
Last Updated: March 29, 2017
Last Verified: March 2017