Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Change in N-Back Task
研究概览
简要总结
In the current study, the investigators aim to understand the role of transcranial direct current stimulation (tDCS) in improving executive function across neuropsychiatric populations known to have deficits in this cognitive domain.
详细描述
In the current study, the investigators aim to understand the role of transcranial direct current stimulation (tDCS) in improving executive function across neuropsychiatric populations known to have deficits in this cognitive domain. The investigators will select 8 relevant diagnostic categories: traumatic brain injury, major depressive disorder, bipolar disorder, schizophrenia, attention deficit hyperactivity disorder, borderline personality disorder and substance use disorder. The study will also include a cohort of healthy controls for comparison.
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
- Single (Participant)
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
- •Male and female outpatients 18-65 years of age
- •A diagnosis of traumatic brain injury, major depressive disorder, bipolar disorder, schizophrenia, attention deficit hyperactivity disorder, borderline personality disorder and substance use disorders 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, shunts, pacemakers, pregnancy.
- •Active substance dependence (except for tobacco and cannabis).
- •Pregnant or nursing females.
- •Inability to participate in testing procedures.
- •Additional exclusion criteria for healthy controls:
- •Diagnosis of psychiatric of neurological disorder
- •Ongoing treatment with any psychotropic medications.
研究组 & 干预措施
Traumatic Brain Injury
This group consists of individuals diagnosed with traumatic brain injury. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
干预措施: Transcranial Direct Current Stimulation (Device)
Major Depressive Disorder
This group consists of individuals diagnosed with major depressive disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
干预措施: Transcranial Direct Current Stimulation (Device)
Bipolar Disorder
This group consists of individuals diagnosed with bipolar disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
干预措施: Transcranial Direct Current Stimulation (Device)
Schizophrenia
This group consists of individuals diagnosed with schizophrenia. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
干预措施: Transcranial Direct Current Stimulation (Device)
Attention Deficit Hyperactivity Disorder
This group consists of individuals diagnosed with attention deficit hyperactivity disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
干预措施: Transcranial Direct Current Stimulation (Device)
Borderline Personality Disorder
This group consists of individuals diagnosed with borderline personality disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
干预措施: Transcranial Direct Current Stimulation (Device)
Substance Use Disorder
This group consists of individuals diagnosed with substance use disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
干预措施: Transcranial Direct Current Stimulation (Device)
Healthy Controls
This group consists of individuals diagnosed with healthy controls. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
干预措施: Transcranial Direct Current Stimulation (Device)
结局指标
主要结局
Change in N-Back Task
时间窗: Baseline to Post-Treatment, 1 Week
Working Memory Task
次要结局
- Change in Multi-Source Interference with International Affective Picture System Task(Baseline to Post-Treatment, 1 Week)
- Change in Stop Signal Task(Baseline to Post-Treatment, 1 Week)
- Change in Iowa Gambling Task(Baseline to Post-Treatment, 1 Week)
- Change in Delayed Discounting Task(Baseline to Post-Treatment, 1 Week)
- Change in Flanker Task(Baseline to Post-Treatment, 1 Week)
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