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

This study is currently recruiting participants.
Verified November 2017 by Stephen Porges, Indiana University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03101826
First Posted: April 5, 2017
Last Update Posted: November 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Latham Centers
Information provided by (Responsible Party):
Stephen Porges, Indiana University
  Purpose

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 the effectiveness of the Listening Project Protocol (LPP) in decreasing the atypical features of the SES in adolescents with PWS. We hypothesize that individuals who complete the LPP will have improved vagal regulation of the heart, improved middle ear muscle regulation, increased voice intonation and improved ability to accurately detect the emotions of others.


Condition Intervention
Prader-Willi Syndrome Behavioral: Listening Project Protocol

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
All participants will receive the active (filtered music) intervention.
Masking: None (Open Label)
Masking Description:
No masking.
Primary Purpose: Basic Science
Official Title: Optimizing the Social Engagement System in Prader-Willi Syndrome: Insights From the Polyvagal Theory

Resource links provided by NLM:


Further study details as provided by Stephen Porges, Indiana University:

Primary Outcome Measures:
  • Effect of Intervention on Autonomic regulation [ Time Frame: Change from 1 week pre-intervention RSA to 1 month post-intervention ]
    Respiratory sinus arrhythmia (RSA)


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • Stability of Autonomic regulation [ Time Frame: Change from 6 months pre-intervention RSA to 1 week pre-intervention ]
    Respiratory sinus arrhythmia (RSA)

  • Immediate effects of intervention on Autonomic regulation [ Time Frame: Change from 1 week pre-intervention RSA to 1 week post-intervention ]
    Respiratory sinus arrhythmia (RSA)

  • Short-term effects of intervention on Autonomic regulation [ Time Frame: Change from 1 week post-intervention RSA to 1 month post-intervention ]
    Respiratory sinus arrhythmia (RSA)

  • Stability of Heart period [ Time Frame: Change from 6 months pre-intervention heart period to 1 week pre-intervention ]
    heart period

  • Immediate effects of intervention on Heart period [ Time Frame: Change from 1 week pre-intervention heart period to 1 week post-intervention ]
    heart period

  • Short-term effects of intervention on Heart period [ Time Frame: Change from 1 week post-intervention heart period to 1 month post-intervention ]
    heart period

  • Stability of Auditory processing [ Time Frame: Change from 6 months pre-intervention Filtered Words to 1 week pre-intervention ]
    Filtered Words subtest of SCAN

  • Immediate effects of intervention on Auditory processing [ Time Frame: Change from 1 week pre-intervention Filtered Words to 1 week post-intervention ]
    Filtered Words subtest of SCAN

  • Short-term effects of intervention on Auditory processing [ Time Frame: Change from 1 week post-intervention Filtered Words to 1 month post-intervention ]
    Filtered Words subtest of SCAN

  • Stability of Auditory processing [ Time Frame: Change from 6 months pre-intervention Competing Words to 1 week pre-intervention ]
    Competing Words subtest of SCAN

  • Immediate effects of intervention on Auditory processing [ Time Frame: Change from 1 week pre-intervention Competing Words to 1 week post-intervention ]
    Competing Words subtest of SCAN

  • Short-term effects of intervention on Auditory processing [ Time Frame: Change from 1 week post-intervention Competing Words to 1 month post-intervention ]
    Competing Words subtest of SCAN

  • Stability of Sensory Sensitivities [ Time Frame: Change from 6 months pre-intervention BBC Sensory Scales to 1 week pre-intervention ]
    BBC Sensory Scales (questionnaire)

  • Stability of Latency to Affect recognition [ Time Frame: Change from 6 months pre-intervention DARE latency to 1 week pre-intervention ]
    Dynamic Affect Recognition Evaluation (DARE) - latency

  • Immediate effects of intervention on Latency to Affect recognition [ Time Frame: Change from 1 week pre-intervention DARE latency to 1 week post-intervention ]
    Dynamic Affect Recognition Evaluation (DARE) - latency

  • Short-term effects of intervention on Latency to Affect recognition [ Time Frame: Change from 1 week post-intervention DARE latency to 1 month post-intervention ]
    Dynamic Affect Recognition Evaluation (DARE) - latency

  • Stability of Accuracy of Affect recognition [ Time Frame: Change from 6 months pre-intervention DARE accuracy to 1 week pre-intervention ]
    Dynamic Affect Recognition Evaluation (DARE) - accuracy

  • Immediate effects of intervention on Accuracy of Affect recognition [ Time Frame: Change from 1 week pre-intervention DARE accuracy to 1 week post-intervention ]
    Dynamic Affect Recognition Evaluation (DARE) - accuracy

  • Short-term effects of intervention on Accuracy of Affect recognition [ Time Frame: Change from 1 week post-intervention DARE accuracy to 1 month post-intervention ]
    Dynamic Affect Recognition Evaluation (DARE) - accuracy

  • Stability of Prosody [ Time Frame: Change from 6 months pre-intervention prosody to 1 week pre-intervention ]
    Analyses of vocal recordings

  • Immediate effects of intervention on Prosody [ Time Frame: Change from 1 week pre-intervention prosody to 1 week post-intervention ]
    Analyses of vocal recordings

  • Short-term effects of intervention on Prosody [ Time Frame: Change from 1 week post-intervention prosody to 1 month post-intervention ]
    Analyses of vocal recordings

  • Stability of Disruptive behavior [ Time Frame: Change from 6 months pre-intervention DBC to 1 week pre-intervention ]
    Developmental Behavior Checklist (DBC) (questionnaire)

  • Immediate effects of intervention on Disruptive behavior [ Time Frame: Change from 1 week pre-intervention DBC to 1 week post-intervention ]
    Developmental Behavior Checklist (DBC) (questionnaire)

  • Short-term effects of intervention on Disruptive behavior [ Time Frame: Change from 1 week post-intervention DBC to 1 month post-intervention ]
    Developmental Behavior Checklist (DBC) (questionnaire)

  • Stability of Oxytocin [ Time Frame: Change from 6 months pre-intervention oxytocin to 1 week pre-intervention ]
    oxytocin levels derived from salivary sample

  • Stability of Vasopressin [ Time Frame: Change from 6 months pre-intervention vasopressin to 1 week pre-intervention ]
    vasopressin levels derived from salivary sample


Estimated Enrollment: 25
Actual Study Start Date: November 1, 2017
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Filtered Music Intervention
All participants will participate in pre-intervention assessments (6 months, 1 week prior) and post-intervention assessments (1 week, 1 month post). The Filtered Music Intervention (i.e., Listening Project Protocol) will last for 1 hour per day, for 5 consecutive days.
Behavioral: Listening Project Protocol
The filtered music intervention will consist of listening to computer-altered acoustic stimulation, designed to modulate the frequency band of vocal music passed to the participant. The frequency characteristics of the acoustic stimulation are selected to emphasize the relative importance of specific frequencies in conveying the information embedded in human speech Modulation of the acoustic energy within the frequencies of human voice, similar to an exaggerated vocal prosody, are hypothesized to recruit and modulate the neural regulation of the middle ear muscles and to functionally reduce sound hypersensitivities and improve auditory processing.
Other Name: Safe and Sound Protocol

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants must be current residents at Latham Centers (LC) School in Brewster MA
  2. Participants must meet criteria for Prader-Willi Syndrome
  3. Participants must be between ages 13 - 25 years
  4. Participants must have normal hearing
  5. Participants must have normal vision (or corrected vision)

Exclusion Criteria:

  1. Individuals with current (or a history of) heart disease
  2. Individuals who are hearing-impaired
  3. Individuals who are being treated for seizure disorder
  4. Individuals who do not read/speak English
  5. Individuals who are sight-impaired without correction
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101826


Contacts
Contact: Patrice Carroll, MSW 508-896-5776 PCarroll@lathamcenters.org
Contact: Keri Heilman, PhD keri_heilman@med.unc.edu

Locations
United States, Massachusetts
Latham Centers School Recruiting
Brewster, Massachusetts, United States, 02631
Contact: Patrice Carroll, MSW         
Sponsors and Collaborators
Indiana University
Latham Centers
Investigators
Principal Investigator: Stephen W Porges, PhD Indiana University/Kinsey Institute
  More Information

Publications:
Responsible Party: Stephen Porges, Distinguished University Scientist, Indiana University
ClinicalTrials.gov Identifier: NCT03101826     History of Changes
Other Study ID Numbers: 1609337519
First Submitted: March 23, 2017
First Posted: April 5, 2017
Last Update Posted: November 15, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stephen Porges, Indiana University:
Polyvagal Theory
Respiratory Sinus Arrhythmia
Heart rate
Social Behavior
Arginine Vasopressin
Dichotic Listening Tests
Oxytocin
Hyperacusis
Affect
Auditory perception
Sound spectrography

Additional relevant MeSH terms:
Syndrome
Prader-Willi Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders