Using Combined Neuroimaging Techniques and Clinical Measures to Assess Feasibility of tDCS as an Intervention in Adult ADD.
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Efficacy will be examined by the change in the CAARS questionnaire from the baseline visit to the determination visit in the treatment group compared to the control group.
研究概览
简要总结
This study aims at combining imaging techniques and clinical evaluations to assess clinical change as well as brain changes that occur as a result of brain stimulation in adult attention deficit disorder.
详细描述
This study will use clinical measures and cognitive tasks covering 3 different functional domains during functional magnetic resonance imaging (fMRI), ElectroEncephaloGram (EEG) and Ultrasound tagged near infrared spectroscopy (UT-NIRS), to assess functional brain changes as a result of a treatment protocol with Transcaranial direct current stimulation (tDCS) in adults suffering from attention deficit disorder (ADD).
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between the ages of 18-65(male and female)
- •Diagnosed as suffering from Attention-Deficit Hyperactivity Disorder according to the DSM IV
- •Patients taking medication for ADHD will give their consent to stop those medication 48 before entering the study and throughout the daily treatments.
- •Gave informed consent for participation in the study
- •If referred by the treating psychiatrist, he or she approves of the subjects participation in the study
排除标准
- •Suffering from other diagnosis on axis 1
- •History of drug or alcohol abuse during the last year
- •Inability to achieve satisfying level of communication with the subject
研究组 & 干预措施
patients
Stimulation using tDCS will be administered daily, 5 days a week for 4 weeks. each session will last 22 minutes during which the anode electrode will be positioned over the right Inferior Frontal Gyrus (IFG) and the Katode electrode over the right Orbito Frontal Gyrus (OFG).
干预措施: Transcranial Direct Current Stimulation (Device)
结局指标
主要结局
Efficacy will be examined by the change in the CAARS questionnaire from the baseline visit to the determination visit in the treatment group compared to the control group.
时间窗: 6 weeks
次要结局
- changes in functional activity after 4 weeks of tDCS treatment during response inhibition(6 weeks)