At-home tDCS as Maintenance Therapy Following Successful Treatment With rTMS, ECT, and Esketamine - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Feasibility, number of completed sessions
研究概览
简要总结
The primary purpuse of this pilot study is to find out whether a home-based transcranial direct current stimulation (tDCS) program is feasible and well tolerated as maintenance therapy and whether there are early signs that it helps maintain the clinical clinical benefits achieved during successful acute inpatient treatment.
Participant population:
Adults (18+) with depressive disorder who had already improved/stabilized after acute treatment at our clinic (esketamine, repetitive transcranial magnetic stimulation , or electroconvulsive therapy).
Main questions:
Feasibility: Do participants reliably complete the home program and stay in the study?
Preliminary effectiveness: Do improvements of depressive symptoms hold up over the 4-week treatment and 2-week follow-up (based on self-report and clinician-rated scales)?
Participants receive standardized instruction from trained staff and a portable tDCS device (with cap and small sponge electrodes) and complete 20 home sessions over 4 weeks (5 per week), each 30 minutes at a very low current (2 mA); the device gently ramps current up/down for comfort.
During treatment, participants use a smartphone app with step-by-step guidance and reminders; sessions are automatically logged. They will also fill out short weekly self-rating questionnaires and join brief phone check-ins every 2 weeks.
Where:
Department and Outpatient Clinic of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Technical University of Munich
Safety & data privacy:
The device monitors electrode contact and pauses automatically if contact is poor. Typical sensations can include mild tingling or redness. The app stores anonymized session data so the care team can track progress; no personal data are exchanged between the app and the stimulator, and access is via a secure clinical portal.
详细描述
Study type Open-label pilot clinical study.
Primary purpose To determine whether a home-based transcranial direct current stimulation (tDCS) maintenance program is feasible and well tolerated, and whether there are early signs that it helps maintain the clinical benefits achieved during successful acute inpatient treatment for depression.
Location Department and Outpatient Clinic of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Technical University of Munich
Participants Adults (≥18 years) with a depressive disorder who already improved or stabilized after acute treatment in our hospital (such as esketamine, repetitive transcranial magnetic stimulation, or electroconvulsive therapy). Participants must be able to give informed consent. People in an acute crisis, with high suicide risk, or with medical reasons that make tDCS unsafe (e.g., certain implants near the head, significant skin disease at the electrode sites) are not included.
What is tDCS? tDCS uses a very low, constant electrical current delivered through two small sponge electrodes on a soft cap to gently modulate brain activity in areas linked to mood regulation. The at-home device ramps the current up and down gradually for comfort, and automatically pauses if contact with the skin is not adequate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Adults (≥18 years).
- •Diagnosis according to ICD-10: recurrent depressive disorder, severe depressive disorder, schizoaffective disorder (depressive episode) or bipolar affective disorder (depressive episode).
- •Clear indication for maintenance therapy after successful acute treatment (esketamine, rTMS, or ECT) with remission/improvement of symptoms.
- •Capacity to provide informed consent, confirmed in a physician-led consent discussion.
排除标准
- •Currently in the acute treatment phase of an affective disorder and non-response to previous treatments.
- •Currently clinically relevant Axis II disorders.
- •Suicidal risk, including suicidal ideation.
- •Contraindications for tDCS: e.g., skin disease at electrode sites, cochlear implants.
- •Neurological, somatic, or psychiatric comorbidities that could compromise validity or safety.
结局指标
主要结局
Feasibility, number of completed sessions
时间窗: 4 weeks from baseline
Feasibility: This is an open-label, single-arm pilot designed to determine whether a home-based tDCS maintenance program can be delivered reliably, safely, and acceptably after successful acute inpatient treatment. It's important to assess feasibility in order to observe whether participants can complete the 4-week, self-administered regimen with remote support and whether the procedure is well tolerated in a real-world home setting. Establishing feasibility is essential to ensure that a larger trial would be both deliverable and acceptable. Feasibility is determined by the number of tDCS sessions completed by patients. It is considered achieved at 75% protocol adherence, i.e., when 15 tDCS sessions are delivered.
Feasibility, number of completed sessions
时间窗: 4 weeks from baseline
Feasibility: This is an open-label, single-arm pilot designed to determine whether a home-based tDCS maintenance program can be delivered reliably, safely, and acceptably after successful acute inpatient treatment. It's important to assess feasibility in order to observe whether participants can complete the 4-week, self-administered regimen with remote support and whether the procedure is well tolerated in a real-world home setting. Establishing feasibility is essential to ensure that a larger trial would be both deliverable and acceptable. Feasibility is determined by the number of tDCS sessions completed by patients. It is considered achieved at 75% protocol adherence, i.e., when 15 tDCS sessions are delivered.
次要结局
- Depressive Symptoms assessed with MADRS(MADRS: Measured in week one, week two, week four during treatment phase and in week six during the follow up phase.)
- BDI II(Measured at day 1 (baseline), week two (after completing ten at home sessions), week four(after completing full treatment) and followup at week 6.)
- Safety based on the number of adverse events(Adverse events are monitored weekly: Baseline (pre-treatment), week 1, 2, 3, 4 and during follow up (week 6))
- Analysis of monitored technical parameters(These parameters will be assessed daily during treatment period, i.e. tDCS treatment day 1-20 automatically)
- Depressive Symptoms assessed with MADRS(MADRS: Measured in week one, week two, week four during treatment phase and in week six during the follow up phase.)
- BDI II(Measured at day 1 (baseline), week two (after completing ten at home sessions), week four(after completing full treatment) and followup at week 6.)
- Safety based on the number of adverse events(Adverse events are monitored weekly: Baseline (pre-treatment), week 1, 2, 3, 4 and during follow up (week 6))
- Analysis of monitored technical parameters(These parameters will be assessed daily during treatment period, i.e. tDCS treatment day 1-20 automatically)
研究者
Ulrike Vogelmann
Dr.med.
Technical University of Munich