Home-based Transcranial Direct Current Stimulation (tDCS) for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Adult ADHD Self-Report Scale
研究概览
简要总结
The investigators are investigating whether home-based tDCS over the course of four weeks can improve ADHD symptom severity and improve dysexecutive functioning (cognitive control). Further, the investigators are investigating whether there is a dose-dependent response to tDCS.
详细描述
This mechanistic clinical trial will be the first of its kind to assess the clinical and cognitive efficacy of tDCS, and its relationship to physiological target engagement. It will also provide critical knowledge about tDCS dosing in a therapeutic context (i.e. 30 days of daily tDCS). Last, it will assess the feasibility and acceptability of home-based neuromodulation therapies for ADHD, reducing the most significant obstacle for the implementation of devices therapies (i.e. daily visits to the hospital for several weeks) and facilitating access to advanced therapeutics to a large population of patients with ADHD. An additional goal of the proposed study is to assess the feasibility and acceptability of home-based neuromodulation therapies for ADHD, reducing the most significant obstacle for the implementation of devices therapies (i.e. daily visits to the hospital for several weeks) and facilitating access to advanced therapeutics to a large population of patients with ADHD.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Soterix devices allow for effective and automated double-blinding.
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
- 否
入选标准
- •Male and female outpatients 18-65 years of age
- •A diagnosis of ADD/ADHD or meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
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.
- •Premorbid neurological conditions (including neurovascular and neurodegenerative diseases such as traumatic brain injury, stroke, Parkinson's, AD and other dementias) and severe psychiatric disorders (bipolar disorder, schizophrenia).
结局指标
主要结局
Adult ADHD Self-Report Scale
时间窗: Week 1 - Week 8 of Study
Investigators will assess changes to these questionnaires in reference to assigned stimulation group to assess changes to ADHD symptomatology across study duration.
P300 Amplitude during Erickson Flanker Task
时间窗: Week 1 - Week 8 of Study
P300, an electrophysiological feature theorized to represent executive functioning, has been previously shown to be notably diminished during the Erickson Flanker Task (EFT) . We will be administering this task to assess changes in P300 during the EFT, and if any changes are related to subjects' assigned condition.
Global Assessment of Functioning (GAF) Scale
时间窗: Week 1 - Week 8 of Study
investigators will use GAF scale to assess the potential feasibility of at-home tDCS for future research.
次要结局
未报告次要终点
研究者
Joan A Camprodon, MD MPH PhD
Division Chief - Neuropsychiatry & Neuromodulation
Massachusetts General Hospital