Role of Transcranial Direct Current Stimulation (tDCS) in Patients With Attention Deficit Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in scores obtained in ASRS scale.
研究概览
简要总结
The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is effective in the treatment attention deficit hyperactivity disorder (ADHD).
Randomized, double-blind Controlled Clinical Trial
Subjects Adults (between 18 and 59 years of age) with ADHD who meet the inclusion criteria and who agree to participate in the study Will recruit from advertisements and clinical referrals to a PRODAH
Active tDCS Anode - right DLPFC Cathode - left DLPFC Electric current is 2mA - Current is applied for 20 min
Sham tDCS Same assembly is used Current is applied for 30 sec
Both groups 5 stimulation sessions on consecutive days
Following tools at Baseline, 1st week, 2 st week, 3st week and 4st week Adult ADHD Self-Report Scale (ASRS) SDS - Sheehan Disability Scale CGI - Clinical Global Impression
详细描述
Randomized, double-blind Controlled Clinical Trial
Subjects Adults (between 18 and 59 years of age) with ADHD who meet the inclusion criteria and who agree to participate in the study Will recruit from advertisements and clinical referrals to a PRODAH
Active tDCS Anode - right DLPFC Cathode - left DLPFC Electric current is 2mA - Current is applied for 20 min
Sham tDCS Same assembly is used Current is applied for 30 sec
Both groups 5 stimulation sessions on consecutive days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 to 45 years
- •Established diagnosis of ADHD according to DSM V through clinical interview and diagnostic criteria applied by trained physicians.
- •ASRS greater than 21 in Part A or B
- •Consent form signed
- •Ability to read and interpret the self-applicable scales
排除标准
- •Medication change in the last month
- •The following comorbidities:
- •Depressive episode with BDI greater than 9
- •Anxiety Disorder with greater than 15 BAI
- •Bipolar Disorder with depressive symptoms, manic or hypomanic in the last 6 months
- •Schizophrenia and other psychotic disorders
- •dependence of substances
- •Mental retardation or dementia
- •Epilepsy or anticonvulsant use
- •Clinically significant medical condition
- •Contraindications for tDCS (metallic implants, cranioencefálica important anatomical change ...)
- •Exclusion criteria retrospectively: two fouls in a row dating to stimulation or three fouls in total days.
结局指标
主要结局
Change in scores obtained in ASRS scale.
时间窗: Autcome measure assesments: day 1 (pre-intervention), day 5 (post-intervention), 1 and 4 weeks later (accompaniment).
This scale is used to access symptoms improvement in ADHD patients, is a self repor scale.
次要结局
- Change in scores obtained in CGI scale.(Autcome measure assesments: day 1 (pre-intervention), day 5 (post-intervention), 1 and 4 weeks later (accompaniment).)
- Change in scores obtained in Sheehan disability scale(Autcome measure assesments: day 1 (pre-intervention), day 5 (post-intervention), 1 and 4 weeks later (accompaniment).)