An interventional study of tDCS in MDD, Severe Depression and Major Depressive Episode, sponsored by Technical University of Munich. Recruiting at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Technical University of Munich · Not applicable, Interventional, and Treatment
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.
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.
What participants will do Training \& setup: Participants receive standardized instruction from trained staff and a portable tDCS device with a cap and sponge electrodes. Correct placement and skin preparation are well demonstrated.
Home treatment (4 weeks): 20 sessions (5 per week) at home, each 30 minutes at 2 mA. The device gives step-by-step prompts; current ramps up/down to improve comfort.
Check-ins \& questionnaires:
Participants complete brief weekly questionnaires and have check-ins every 2 weeks. After finishing the 4-week program, there is a 2-week follow-up with a final assessment.
Usual care:
Ongoing medications or psychotherapy may continue unchanged and is not standardized in this pilot-study.
What the study measures:
Feasibility (primary objective): Is the at-home maintenance treatment after acute inpatient treatment well tolerated by patients? Improvements in MADRS and self reporting questionnaires as BDI-II.
Adherence:
How many of the 20 planned sessions each participant actually completes.
Safety:
Number and type of adverse events (AEs) and any device-related issues.
Preliminary effectiveness:
Whether maintenance or improvements hold up during treatment and follow-up are assessed using standardized self-rated and clinician-rated questionnaires.
Adverse effects:
Typical sensations can include mild tingling, redness, or a light headache; serious events are uncommon. Participants can pause or stop at any time and contact the team for support.
Data handling and privacy The app stores anonymized session data (e.g., time and completion of sessions) so the team can monitor progress.No personal identifiers are transmitted between the app and the stimulator. Access to study data is restricted to the clinical team via a secure portal.
Why this pilot matters Before running a large, controlled trial, we need to confirm that a home-based tDCS program is practical to deliver, acceptable to participants, and shows early signs of maintaining post-acute clinical benefits. Results from this pilot will guide decisions about a future randomized, posssibly sham-controlled study with a longer follow-up focused on relapse prevention.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 30 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Transcranial Direct Current Stimulation (tDCS) at home, 20 sessions, 2mA (5 days/week, for 4 weeks) as at home maintenance treatmentafter successfull ECT, rTMS or Esketamine treatment.
Device: tDCS
Description: Transcranial Direct Current Stimulation delivered at an intensity of 2 mA over electrodes at F3/F4 (bifrontal, over DLPFC), for 30 minutes a day, Monday to Friday, for a total 20 sessions.
Feasibility, number of completed sessions
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.
Time frame: 4 weeks from baseline
Depressive Symptoms assessed with MADRS
Major Depression psychiatric symptoms assessed with the Montgomery Asberg Depression Rating Scale (MADRS). MADRS values are interpreted as follows: 0-6 = No depression, 07-19 = mild, 20-34 = moderate, 35-60 = severe. Outcome is the Difference in MADRS Score from baseline to post-treatment visit at week four and at week six (follow up phase)
Time frame: MADRS: Measured in week one, week two, week four during treatment phase and in week six during the follow up phase.
BDI II
Major Depression psychiatric symptoms assessed with the Beck Depression Inventory (BDI-II). Outcome values are interpreted as follows: 0-13 = Minimal depression, 14-19 = Mild depression, 20-28 = Moderate depression, 29-63 = Severe depression
Time frame: 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
Typical adverse events may include mild tingling or redness.
Time frame: Adverse events are monitored weekly: Baseline (pre-treatment), week 1, 2, 3, 4 and during follow up (week 6)
Analysis of monitored technical parameters
Safety will be assessed not only by adverse events but also by device- and app-logged technical parameters that reflect safe delivery in the home setting. such as electrode-scalp contact quality as well as device/app error codes and battery-related interruptions; and the need for make-up sessions attributable to technical causes.
Time frame: These parameters will be assessed daily during treatment period, i.e. tDCS treatment day 1-20 automatically
Plan to share: Yes — All anonymised study outcomes will be shared, including questionnaire, physiological, and device data.
Supporting information: Study protocol, Icf, Analytic code
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