- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04526379
Study of Emotion and Cognition Abilities of Children With PWS and Proposition of an Innovative Remediation (PRACOM1)
August 22, 2023 updated by: University Hospital, Toulouse
Communication in Prader-Willi Syndrome: Study of Emotional Control Related to Behavioral Disorders, Their Daily Repercussions and Examination of an Innovative Therapy: Transcutaneous Electrical Nerve Stimulation of the Vagus Nerve - PRACOM1
The present project project is divided in two parts.
The primary aim of the part 1 of this study is to evaluate emotional control abilities of children with Prader-Willi syndrome (PWS) aged from 9 to 15 years and to study repercussions of this supposed lack of abilities on cognitive capacities and behavioral troubles.
The study also evaluate influence of the emotional symptomatology of patients on quality of parents' life and on the care of parents and scholar/institutional caregivers.
In the second part of this study, the study evaluate the feasibility and the tolerance to a non-invasive device supposed to reduce emotional symptoms in this disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Prader-Willi Syndrome (PWS) is a rare genetic disorder involving a variety of clinical, behavioral and cognitive symptoms.
83 to 97% of patients have episodes of temper tantrum, associated with an important emotional lability.
These different cognitive and behavioral limitations are barriers to the social integration of patients.
The PWS also has repercussions on well-being and quality of life of the family.
Thus, the present project focuses on the characteristics of emotional control related to the anger of children with PWS and its behavioral, cognitive and social implications.
In addition, at a therapeutic level, our project assumes that transcutaneous electrical nerve stimulation (t-VNS), a non-invasive, safe and inexpensive method, could be effective in reducing the severity of behavioral disorders such as temper tantrums while improving cognitive performance and social communication in the PWS.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- 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
- Name: Maithé TAUBER, MD
- Phone Number: 0561777204
- Email: Tauber.m@chu-toulouse.fr
Study Locations
-
-
-
Toulouse, France
- University Hospital
-
-
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
Ages Eligible for Study
9 years to 15 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age from 9 to 15 years old
- Prader-Willi syndrome with identified genotype.
- No psychiatric disorder neither PWS.
- Severe global symptomatology attested by a CGI-S score
Exclusion Criteria:
- Identified psychiatric or behavioral disorders
- Severe visual or hearing impairment.
- Sleep apnea syndrome treated with non-invasive ventilation,
- Epileptic seizures
- Cardiac disorders.
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: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: children with PWS
Evaluation of cognitive abilities of children with PWS by several cognitive tasks and neuropsychological tests.
|
Evaluation of behavioral disorders of children with PWS by questionnaires
Evaluation of the influence of 6 month-stimulation by t-VNS on emotional, cognitive, and behavioral/clinical characteristics of 12 children with PWS on 30 PWS patients included.
|
Other: non affected children
Evaluation of cognitive abilities of children with PWS compared to a non-pathologic population of children by several cognitive tasks and neuropsychological tests
|
Evaluation of behavioral disorders of children with PWS by questionnaires
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
assessment of the level of emotional control
Time Frame: day 0
|
composite score of emotional control level of children with PWS composed of scores of emotional lability
|
day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of behavioral disorders of children with PWS by CBCL (Child Behavior Checklist) scale
Time Frame: month 6
|
CBCL (Child Behavior CheckList) scale: is a questionnaire comprising 1) an adaptive functioning scale (activities, social and school spheres), 2) a syndrome scale (social withdrawal, anxiety / depression, somatic complaints, social problems, thinking problems, attention problems, behavior problems and aggressiveness; total of internalized problems and total of externalized problems), 3) a DSM-oriented scale (Lengua et al., 2001; anxiety, attention problems / hyperactivity, behavior problems, depression, opposition / mistrust, social problems / immaturity, somatization).
(duration = 20 ') - there is no minimum and maximum values as this is an evaluation of behavioral disorders
|
month 6
|
Evaluation of behavioral disorders of children with PWS by Hyperphagia Questionnaire
Time Frame: month 6
|
HQ-CT (Hyperphagia Questionnaire) scale: The HQ-CT (Hyperphagia Questionnaire for Use in Prader-Willi Syndrome Clinical Trials, Fehnel et al., 2015, appendix 10) is a scale derived from the Dykens hyperphagia questionnaire (Dykens et al., 2007).
The specificity of the Dykens questionnaire makes it a favored tool in the international literature in the evaluation of the eating behavior of patients with PWS (Crain, 2010).
The HQ-CT was created specifically to assess the eating behavior of these patients in clinical trials.
It consists of 9 items for which a person taking care of the patient (family or caregiver) indicates the frequency and severity of the behavior described on a 5-point Likert scale (with 1 = absence of the behavior and 5 = very frequent behavior or severe) (⍺ = .91).
(duration = 5 ') - so 1 is the minimum value and 5 the maximum value and higher scores mean a worse outcome
|
month 6
|
Evaluation of cognitive abilities of children with PWS
Time Frame: 2 days
|
emotional language task
|
2 days
|
Test of evaluation of cognitive abilities
Time Frame: 2 days
|
multimodal emotional recognition test MERT
|
2 days
|
Evaluation of cognitive abilities
Time Frame: 2 days
|
WISC-V
|
2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maithé TAUBER, MD, University Hospital, Toulouse
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)
September 7, 2020
Primary Completion (Actual)
December 7, 2020
Study Completion (Actual)
April 27, 2022
Study Registration Dates
First Submitted
March 3, 2020
First Submitted That Met QC Criteria
August 24, 2020
First Posted (Actual)
August 25, 2020
Study Record Updates
Last Update Posted (Actual)
August 23, 2023
Last Update Submitted That Met QC Criteria
August 22, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Disease
- Congenital Abnormalities
- Overnutrition
- Nutrition Disorders
- Overweight
- Genetic Diseases, Inborn
- Intellectual Disability
- Abnormalities, Multiple
- Chromosome Disorders
- Obesity
- Syndrome
- Prader-Willi Syndrome
Other Study ID Numbers
- RC31/18/0335
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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