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

NCT04526379 | Completed

• 1 other identifier: RC31/18/0335
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prader-Willi Syndrome

Keywords

Emotion; Cognition

Outcome Measures

Primary Outcomes (1)

• assessment of the level of emotional control

  composite score of emotional control level of children with PWS composed of scores of emotional lability

  day 0

Secondary Outcomes (5)

• Evaluation of behavioral disorders of children with PWS by CBCL (Child Behavior Checklist) scale

  month 6

• Evaluation of behavioral disorders of children with PWS by Hyperphagia Questionnaire

  month 6

• Evaluation of cognitive abilities of children with PWS

  2 days

• Test of evaluation of cognitive abilities

  2 days

• Evaluation of cognitive abilities

  2 days

Study Arms (2)

children with PWS

EXPERIMENTAL

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

Behavioral: Questionnaires; Device: t-VNS

non affected children

OTHER

Evaluation of cognitive abilities of children with PWS compared to a non-pathologic population of children by several cognitive tasks and neuropsychological tests

Behavioral: Questionnaires

Interventions

Questionnaires BEHAVIORAL

Evaluation of behavioral disorders of children with PWS by questionnaires

children with PWS; non affected children

t-VNS 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.

children with PWS

Eligibility Criteria

• Age: 9 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Identified psychiatric or behavioral disorders
• Severe visual or hearing impairment.
• Sleep apnea syndrome treated with non-invasive ventilation,
• Epileptic seizures
• Cardiac disorders.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital

Toulouse, France

Location

MeSH Terms

Conditions

Prader-Willi Syndrome

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Maithé TAUBER, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: August 25, 2020
• Study Start: September 7, 2020
• Primary Completion: December 7, 2020
• Study Completion: April 27, 2022
• Last Updated: August 23, 2023

Record last verified: 2023-08

Locations

FR (1)