The Characteristics of Prepulse Inhibition in Children and Adolescents Suffering From Attention Deficit Disorder: With and Without Medication.
试验速览
- 阶段
- 不适用
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Electromyography (EMG) of the right and the left Orbicularis oculi muscle will be recorded during the Prepulse inhibition test
研究概览
简要总结
The purpose of this study is to show that Prepulse inhibition test of acoustic startle response is an indicator of objective diagnostic characteristics of attention deficit disorder in children and adolescents.
by demonstrating that Prepulse inhibition test of acoustic startle response is impaired in children and adolescents suffering from attention deficit disorder in the relation to the normal function described in the literature.
The investigators will try to prove our hypothesis by an experiment that consists of two phases:
Phase I (about 25 minutes):
The patient will enter the room, will be asked to sit on a chair, and will be asked to look at a computer screen showing silent video of aquarium fish, then the patient will be connected to both the Prepulse inhibition test device and the Galvanic skin response device and pass the tests.
Phase II (about 25 minutes):
After completion of Phase I, each participant will receive his daily regular dose of methylphenidate and after an hour and a half from taking the drug, will repeat the tests, both the Prepulse inhibition test and the Galvanic skin response test.
Duration of the entire experiment is 140 minutes (two hours and twenty minutes).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 7-18
- •Diagnosed with attention deficit hyperactivity disorder according to Diagnostic and statistical manual of mental disorders, fifth edition- Clinical diagnostic interview was performed.
- •Receive drug therapy with methylphenidate doses ranging from 0.3 mg / kg to 1 mg / kg.
- •The participant is treated with methylphenidate at least two months prior to the experiment.
排除标准
- •Chronic neurological diseases.
- •Developmental delay.
- •Psychotic or major effective disorder (psychotic state now or in the past, schizophrenia, schizoaffective, depression, bipolar disorder)
- •Substance abuse.
- •Mental retardation.
- •Contraindicated for the treatment of methylphenidate.
- •Hearing problems.
- •Pregnancy week 20 and thereafter
结局指标
主要结局
Electromyography (EMG) of the right and the left Orbicularis oculi muscle will be recorded during the Prepulse inhibition test
时间窗: The outcome measure will be assessed imediatly during each test and the participants will be followed for the whole duration of the experiment, an expected average of 3 hours
次要结局
- Galvanic skin response will be measured by conductivity (Mv) units during the Prepulse inhibition test(The outcome measure will be assessed imediatly during each test and the participants will be followed for the whole duration of the experiment, an expected average of 3 hours)
研究者
ESSAM DAOD
Dr.
HaEmek Medical Center, Israel