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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- assessment of the level of emotional control
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Identified psychiatric or behavioral disorders
- •Severe visual or hearing impairment.
- •Sleep apnea syndrome treated with non-invasive ventilation,
- •Epileptic seizures
- •Cardiac disorders.
结局指标
主要结局
assessment of the level of emotional control
时间窗: day 0
composite score of emotional control level of children with PWS composed of scores of emotional lability
次要结局
- Test of evaluation of cognitive abilities(2 days)
- Evaluation of cognitive abilities(2 days)
- Evaluation of cognitive abilities of children with PWS(2 days)
- Evaluation of behavioral disorders of children with PWS by Hyperphagia Questionnaire(month 6)
- Evaluation of behavioral disorders of children with PWS by CBCL (Child Behavior Checklist) scale(month 6)