Home-based Transcranial Direct Current Stimulation (tDCS) for Major Depressive Disorders (MDD)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 34
- 试验地点
- 8
- 主要终点
- Percentage of incomplete and missed sessions (%)
研究概览
简要总结
This is an open label pilot feasibility telemedicine study. This pilot will involve a total of 37 at-home stimulation sessions (30-minutes each) of multichannel excitatory tDCS targeting the left dorsolateral prefrontal cortex (DLPFC) administered over 8 weeks, with a follow-up period of 4 weeks following the final stimulation session.
详细描述
This is an open label pilot feasibility telemedicine study. This pilot will involve a total of 37 at-home stimulation sessions (30-minutes each) of multichannel excitatory tDCS targeting the left dorsolateral prefrontal cortex (DLPFC) administered over 8 weeks, with a follow-up period of 4 weeks following the final stimulation session.
The main objective of the study is to assess the feasibility and safety of home-based tDCS for patients with MDD.
The treatment course will consist of an acute phase of 28 tDCS sessions, conducted daily (7 days per week) over 4 weeks.
Thereafter, participants will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:
- Three tDCS sessions applied once every other day.
- Three tDCS sessions applied once every third day.
- Three tDCS sessions applied once every fourth day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major Depressive Disorder
- •Currently experiencing a major depressive episode of at least four weeks' duration
- •MADRS score at least 20 at trial entry.
- •Taking at least one approved antidepressant medication (except bupropion).
- •Has a healthcare provider, and a companion who can help administer study treatments; and be able to connect frequently with study staff
- •Access to wireless internet (wifi) connection
排除标准
- •Any psychotic disorder.
- •Concurrent benzodiazepine medication.
- •High suicide risk
- •History of significant neurological disorder.
- •Skin lesions on the scalp at the proposed electrode sites.
- •Any antidepressant medications will be permitted (except bupropion) provided the medication dose has been unchanged for 4 weeks prior to trial entry.
- •Any cranial metal implants (excluding ≤1 mm thick epicranial titanium skull plates and dental fillings) or
- •Medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagus nerve stimulator);
- •Previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm.
- •Substance use disorder (including alcohol) within the past year.
结局指标
主要结局
Percentage of incomplete and missed sessions (%)
时间窗: From baseline to 4-week follow up across study subjects
Feasibility will be evaluated using home-based data as recorded in the Neuroelectrics portal. Range \[0,100\]. Higher is worse
Incidence of Serious Adverse Events (SAE)
时间窗: From baseline to 4-week follow up across study subjects
Safety will be assessed by number and type of side effects
Median percentage change in Montgomery-Asberg Depression Mood Rating Scale (MADRS) scores
时间窗: From baseline to 4-week follow up across study subjects
The primary efficacy measure for this study will be the median percent change from baseline to the end of the 4-week post-treatment follow-up period in the observer-rated Montgomery-Asberg Depression Mood Rating Scale (MADRS) (Montgomery and Asberg, 1979). Range \[0,100\]. Higher is worse
次要结局
- Change in the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) score(Change from baseline to 4-week follow-up in the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF))
- Change in the Quick Inventory of Depressive Symptomatology (QIDS-SR) score(Change from baseline to 4-week follow-up in the participant-rated Quick Inventory of Depressive Symptomatology (QIDS-SR))
- Response rate(From baseline to the 4-week follow-up)
- Median percentage change in Montgomery-Asberg Depression Mood Rating Scale (MADRS) scores(From baseline to the end of week 4 of treatment, and to the end of week 8 of treatment.)