Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression: A Home-Based Feasibility and Safety Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Feasibility (Recruitment)
研究概览
简要总结
The investigators propose a single-arm, open-label study to evaluate the effectiveness, safety, tolerability and feasibility of at-home transcranial direct current stimulation (tDCS) as a treatment for depression, particularly in cases where patients have not responded well to traditional therapies. Treatment will be delivered over a 2-week period with daily weekday treatments i.e., five tDCS sessions, each lasting 20 minutes, spaced by approximately 20-minute inter-session intervals, for a total of three hours a day. Participants will self-administer treatment at home under direct remote supervision. Pre- and post- treatment neurophysiological biomarkers sessions will also be carried out. The study aims to examine changes in mood, brain activity, and related clinical outcomes before, during, and after treatment, with the goal to provide more information that can be used for future studies.
PLEASE NOTE: THERE WILL BE 4 APPOINTMENTS THAT MUST OCCUR IN PERSON IN SAN DIEGO, CA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People between the ages of 18 and 85 at the time of screening.
- •Currently diagnosed with Major Depressive Disorder (MDD) as measured by the MINI and a MADRS score of ≥
- •Safe for TMS as measures by the TMS Adult Safety Screening (TASS).
- •Medical records confirming a history of failing to achieve clinical response to an adequate antidepressant trial as defined an Antidepressant Treatment History Form (ATHF) score ≥ 3 or ) or shown intolerance to at least two inadequate trials (score 1 or 2), without psychiatric illness due to a general medical condition.
- •Stable internet connection and a device compatible with Microsoft Teams.
排除标准
- •History of psychotic or bipolar disorder or depression with psychotic features;
- •Significant borderline personality disorder;
- •Significant comorbid obsessive-compulsive or post-traumatic stress:
- •Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal;
- •Clinically significant suicidality disorder;
- •Chronic depression (defined as of over 5 years duration);
- •Pregnancy or lactation, lack of adequate birth control in women of childbearing age;
- •History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent symptoms;
- •Unstable medical illness;
- •Contraindication to receiving tDCS (e.g., ferromagnetic implant, history of seizure, known brain lesion);
- •History of TMS (greater than 15 sessions) without a clinically meaningful response.; History of ketamine (greater than 4 sessions) without a clinically meaningful response;
- •Require a benzodiazepine with a dose > lorazepam 2 mg/day;
- •dermatological conditions contraindicating tDCS;
- •Non-correctable sensory impairments;
- •Inability to consent or participate as an outpatient
研究组 & 干预措施
Spaced Transcranial Direct Current Stimulation Treatment
tDCS, a non-invasive neuromodulation technique that applies low-intensity, direct electrical stimulation to the cortex via scalp electrodes, has been extensively researched as a potential treatment for MDD. tDCS enhances neuroplasticity, which is theorized to be responsible for its therapeutic effects and has been presented as a cost-effective solution for MDD. Preclinical evidence supports the potential advantage of spaced stimulation with tDCS to maximally engage neuroplasticity.
tDCS sessions will be self-administered at home under the supervision of a trained clinical research coordinator.
Each treatment day will consist of five tDCS sessions, each lasting 20 minutes, spaced by approximately 20-minute inter-session intervals, for a total of three hours per day.
Other Names:
- tDCS
- Soterix Medical miniCT
干预措施: Spaced Transcranial Direct Current Stimulation (tDCS) (Device)
结局指标
主要结局
Feasibility (Recruitment)
时间窗: From baseline clinical assessment prior to treatment to 12 weeks after last treatment.
Recruitment rate will be measured as the number of patients enrolled by the conclusion of the study, reported as a whole number.
Feasibility (Retention)
时间窗: From baseline clinical assessment prior to treatment, to 12 weeks after last treatment.
Retention rate will be measured as the percentage of enrolled patients who complete all study visits, reported as a percentage.
Feasibility (Adherence)
时间窗: From baseline clinical assessment prior to treatment, to 12 weeks after last treatment.
The proportion of completed sessions relative to the total prescribed sessions, expressed as a percentage.
Safety of at-home spaced tDCS
时间窗: From baseline clinical assessment prior to treatment, to 12 weeks after last treatment.
Safety will be measured by the number of serious adverse events (SAEs)
Tolerability to spaced tDCS
时间窗: From baseline clinical assessment prior to treatment, to 12 weeks after last treatment.
Tolerability will be measured by the number of adverse events (AEs).
次要结局
- Changes from pre-treatment depressive symptomatology in post-treatment(From baseline clinical assessment prior to treatment, to 12 weeks after last treatment.)
- Biomarker Discovery: Short-Interval Intracortical Inhibition (SICI) via TMS-EMG(From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment.)
- Biomarker Discovery: Intracortical Facilitation (ICF) via TMS-EMG(From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment.)
- Biomarker Discovery: Cortical Silent Period (CSP) via Transcranial Magnetic Stimulation-Electromyography (TMS-EMG)(From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment.)
- Biomarker Discovery: TMS-Evoked Potential (TEP) Component Amplitudes via TMS-EEG(From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment.)
- Biomarker Discovery: Resting-State Electroencephalography (rsEEG)(From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment.)
研究者
Jean-Philippe Miron
MD, PhD
University of California, San Diego