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

March 30, 2023 updated by: Stephen Porges, Indiana University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Brewster, Massachusetts, United States, 02631
        • Latham Centers School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Safe and Sound Protocol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effect of Intervention on Autonomic regulation
Time Frame: Change from 1 week pre-intervention RSA to 1 month post-intervention
Respiratory sinus arrhythmia (RSA)
Change from 1 week pre-intervention RSA to 1 month post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effect of Intervention on Heart period
Time Frame: Change from 1 week pre-intervention heart period to 1 month post-intervention
heart period
Change from 1 week pre-intervention heart period to 1 month post-intervention
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
Change from 1 week pre-intervention Filtered Words to 1 month post-intervention
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
Change from 1 week pre-intervention Competing Words to 1 month post-intervention
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)
Change from 1 week pre-intervention BBC Sensory Scales to 1 month post-intervention
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
Change from 1 week pre-intervention DARE (latency) to 1 month post-intervention
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
Change from 1 week pre-intervention DARE (accuracy) to 1 month post-intervention
Effect of Intervention on Prosody
Time Frame: Change from 1 week pre-intervention Prosody to 1 month post-intervention
Analyses of vocal recordings
Change from 1 week pre-intervention Prosody to 1 month post-intervention
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)
Change from 1 week pre-intervention DBC to 1 month post-intervention
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
Change from 1 week post-intervention LPP to 1 month post-intervention
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
Change from 1 week pre-intervention oxytocin to 1 month post-intervention
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
Change from 1 week pre-intervention vasopressin to 1 month post-intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stability of Autonomic regulation
Time Frame: Change from 6 months pre-intervention RSA to 1 week pre-intervention
Respiratory sinus arrhythmia (RSA)
Change from 6 months pre-intervention RSA to 1 week pre-intervention
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)
Change from 1 week pre-intervention RSA to 1 week post-intervention
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)
Change from 1 week post-intervention RSA to 1 month post-intervention
Stability of Heart period
Time Frame: Change from 6 months pre-intervention heart period to 1 week pre-intervention
heart period
Change from 6 months pre-intervention heart period to 1 week pre-intervention
Immediate effects of intervention on Heart period
Time Frame: Change from 1 week pre-intervention heart period to 1 week post-intervention
heart period
Change from 1 week pre-intervention heart period to 1 week post-intervention
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
Change from 1 week post-intervention heart period to 1 month post-intervention
Stability of Auditory processing
Time Frame: Change from 6 months pre-intervention Filtered Words to 1 week pre-intervention
Filtered Words subtest of SCAN
Change from 6 months pre-intervention Filtered Words to 1 week pre-intervention
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
Change from 1 week pre-intervention Filtered Words to 1 week post-intervention
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
Change from 1 week post-intervention Filtered Words to 1 month post-intervention
Stability of Auditory processing
Time Frame: Change from 6 months pre-intervention Competing Words to 1 week pre-intervention
Competing Words subtest of SCAN
Change from 6 months pre-intervention Competing Words to 1 week pre-intervention
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
Change from 1 week pre-intervention Competing Words to 1 week post-intervention
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
Change from 1 week post-intervention Competing Words to 1 month post-intervention
Stability of Sensory Sensitivities
Time Frame: Change from 6 months pre-intervention BBC Sensory Scales to 1 week pre-intervention
BBC Sensory Scales (questionnaire)
Change from 6 months pre-intervention BBC Sensory Scales to 1 week pre-intervention
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
Change from 6 months pre-intervention DARE latency to 1 week pre-intervention
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
Change from 1 week pre-intervention DARE latency to 1 week post-intervention
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
Change from 1 week post-intervention DARE latency to 1 month post-intervention
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
Change from 6 months pre-intervention DARE accuracy to 1 week pre-intervention
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
Change from 1 week pre-intervention DARE accuracy to 1 week post-intervention
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
Change from 1 week post-intervention DARE accuracy to 1 month post-intervention
Stability of Prosody
Time Frame: Change from 6 months pre-intervention prosody to 1 week pre-intervention
Analyses of vocal recordings
Change from 6 months pre-intervention prosody to 1 week pre-intervention
Immediate effects of intervention on Prosody
Time Frame: Change from 1 week pre-intervention prosody to 1 week post-intervention
Analyses of vocal recordings
Change from 1 week pre-intervention prosody to 1 week post-intervention
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
Change from 1 week post-intervention prosody to 1 month post-intervention
Stability of Disruptive behavior
Time Frame: Change from 6 months pre-intervention DBC to 1 week pre-intervention
Developmental Behavior Checklist (DBC) (questionnaire)
Change from 6 months pre-intervention DBC to 1 week pre-intervention
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)
Change from 1 week pre-intervention DBC to 1 week post-intervention
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)
Change from 1 week post-intervention DBC to 1 month post-intervention
Stability of Oxytocin
Time Frame: Change from 6 months pre-intervention oxytocin to 1 week pre-intervention
oxytocin levels derived from salivary sample
Change from 6 months pre-intervention oxytocin to 1 week pre-intervention
Stability of Vasopressin
Time Frame: Change from 6 months pre-intervention vasopressin to 1 week pre-intervention
vasopressin levels derived from salivary sample
Change from 6 months pre-intervention vasopressin to 1 week pre-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Latham Centers

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephen W Porges, PhD, Indiana University/Kinsey Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 8, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 8, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1609337519

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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