Pilot Study Investigating the Effects of Cathodal Transcranial Direct Current Stimulation (tDCS) on Executive Functions of Patients With Autism Without Mental Retardation. TRANSFEX Study
试验速览
- 阶段
- 不适用
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Cognitive dysexecutive functions
研究概览
简要总结
It's an interventional, prospective and monocentric pilot study concerning adult patients with autism without mental retardation.
The primary outcome is to assess the effects of cathodal transcranial direct current stimulation (tDCS) on the left dorsolateral prefrontal cortex (DLPFC) on the executive functions of patients with autism without mental retardation or with Asperger syndrome.
The secondary outcomes are to evaluate the safety of this treatment and to evaluate its impact on impaired social communication and on restricted or repetitive behaviors.
详细描述
The patients concerned by the study are aged 20 to 50 years old. They meet ICD-10 criteria for autism without mental retardation or Asperger syndrome and they have adaptive capacity and autonomy complaints. They stable treatments for at least 4 weeks prior and during all the study and no history of tDCS. Women of childbearing age with no adequate contraception, pregnant or lactating women are excluded.
This is an interventional, prospective and monocentric pilot study. The patient is informed about the clinical study during the psychiatric consultation. The patient is provided with a cooling-off period of several days. During the inclusion visit, the executive functions of the patient are assessed (WSCT, Stroop, TMT A and B and verbal fluency test). If 2 pathological tests are found among all measured scores: administration of ISDC and EC2R (interview of the person accompanying) and planning of the first tDCS session 15 days later. If no pathological test is found : study exit.
The treatment consists in 10 sessions of cathodal tDCS applied over the left dorsolateral prefrontal cortex (DLPFC) at 2mA. Each session lasts 15 minutes. They are 2 sessions per day.
Ten days after the end of tDCS treatment, patients are assessed for executive functions and behavioral dysexecutive functions (EC2R and ISCD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With ICD-10 criteria for autism without mental retardation or Asperger syndrome;
- •Patient with adaptive capacity and autonomy complaints.
- •Patients with stable treatments for at least 4 weeks prior and during all the study;
- •Patient with no history of tDCS;
- •Patients affiliated to a social security system;
- •Patients who give their informed written consents;
- •For women of childbearing age: effective contraception; required (estrogen and progestogen or intra-uterine device or tubal ligation) for at least 1 month before starting treatment (a negative pregnancy test has been obtained).
排除标准
- •Skin disease, dementia, history of epileptic seizures, brain tumor or metallic implants/implanted electrical devices.
- •Patients who followed à cognitive remediation program during the last 6 months;
- •Subjects currently treated with magnetic or electrical stimulation techniques (e.g.: transcutaneous or root stimulation).
- •Women of childbearing age with no adequate contraception, pregnant or lactating women;
- •Patients participating or having participated in an interventional clinical trial within 30 days prior to the inclusion visit;
- •Subjects who are deprived of their liberty by decision of a judicial or administrative authority.
研究组 & 干预措施
treated arm
Patients received cathodal tDCS applied over the left dorsolateral prefrontal cortex at 2 mA during 15 minutes. They have 10 sessions in 5 consecutive days, 2 sessions per day.
干预措施: tDCS (Device)
结局指标
主要结局
Cognitive dysexecutive functions
时间窗: 30 days
Score changes in Wisconsin Card Sorting test between assessment at day 1(inclusion) and assessment at day 30 (end of the study).
次要结局
- Score changes in the tDCS adapted version of the Udvalg pour Kliniske Undersøgelser (UKU) Side Effect Rating Scale(30 days)
- Trail Making Test A and B(30 days)
- Verbal Fluency Test(30 days)
- Behavioral dysexecutive functions(30 days)
- Stroop Test(30 days)