Study of Emotion and Cognition Abilities of Children With PWS and Proposition of an Innovative Remediation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-07

Study Completion Date

2022-04-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prader-Willi Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The study consists of 2 parts. The first part compares 30 children with PWS compared to 30 control children without PWS. The second part will be based on 12 children with PWS who have undergone part 1.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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children with PWS

Evaluation of cognitive abilities of children with PWS by several cognitive tasks and neuropsychological tests.

Group Type EXPERIMENTAL

Questionnaires

Intervention Type BEHAVIORAL

Evaluation of behavioral disorders of children with PWS by questionnaires

t-VNS

Intervention Type DEVICE

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.

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

Group Type OTHER

Questionnaires

Intervention Type BEHAVIORAL

Evaluation of behavioral disorders of children with PWS by questionnaires

Interventions

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Questionnaires

Evaluation of behavioral disorders of children with PWS by questionnaires

Intervention Type BEHAVIORAL

t-VNS

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

9 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes