A Dose-Response Study of the Cognitive and Physiological Effects of tDCS to the DLPFC
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change in Accuracy and Reaction Time in Attention and Working Memory
研究概览
简要总结
To determine the cognitive and neurophysiological dose-response relationships of anodal tDCS to the left DLPFC as a function of absolute current intensity, individualized E-field intensity, and stimulation duration.
详细描述
To determine the cognitive and neurophysiological dose-response relationships of anodal tDCS to the left DLPFC as a function of absolute current intensity, individualized E-field intensity, and stimulation duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female outpatients 18-55 years of age
- •A diagnosis of ADD/ADHD or meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
- •Patient will be either off stimulant medications or, if undergoing treatment with stimulants, will be asked to discontinue two days prior to the experiment, under physician-guided protocol, and allowed to resume afterwards. Subjects may resume stimulant use between the two study visits so long as they discontinue use two days prior to the second study visit. If fatigue is problematic in subjects discontinuing medication, they will be allowed to continue with the study if they are able to follow the suggested taper plan (50% of the dose day one, 25% dose day 2, stop day of visit (day 3)).
- •If on non-stimulant medications, dose must have been stable for at least 4 weeks.
排除标准
- •Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.
- •Active substance dependence (except for tobacco).
- •Pregnant or nursing females.
- •Inability to participate in testing procedures.
- •Inclusion Criteria (Healthy Control)
- •1. Male and female outpatients 18-55 years of age
- •Exclusion Criteria (Healthy Control)
- •Diagnosis of psychiatric of neurological disorder
- •Ongoing treatment with any psychotropic medications.
- •Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.
- •Active substance dependence (except for tobacco).
- •Pregnant or nursing females.
- •Inability to participate in testing procedures.
研究组 & 干预措施
ADHD
Patients with ADHD.
干预措施: Transcranial Direct Current Stimulation (Device)
Healthy Control
Volunteers without Neuropsychiatric Disorders.
干预措施: Transcranial Direct Current Stimulation (Device)
结局指标
主要结局
Change in Accuracy and Reaction Time in Attention and Working Memory
时间窗: Change Before and After Stimulation on Each of the Four Visits, Average of 2-6 Weeks
Measured using Eriksen Flanker Task (EFT)
次要结局
- Amplitude of Electroencephalogram (EEG) Event Related Potentials(Change Before and After Stimulation on Each of the Four Visits, Average of 2-6 Weeks)
研究者
Joan A Camprodon, MD MPH PhD
Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation
Massachusetts General Hospital