MDDMaintenanceDCNCT07269964
At-Home tDCS as Maintenance Therapy
A study testing tDCS in people with MDD and Severe Depression, run by Technical University of Munich at 2 sites in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MDD, Severe Depression, Major Depressive Episode
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Oct 2024to 29 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Enrolling by invitation
Technical University of Munich, TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy, Munich,
München, Bavaria, 81675
- Recruiting
Department of Psychiatry and Psychotherapy, Technical University of Munich, University Hospital
München, 81675
Ulrike Vogelmann, MD, +498941406882, ulrike.vogelmann@mri.tum.de
About this study
Official title: At-home tDCS as Maintenance Therapy Following Successful Treatment With rTMS, ECT, and Esketamine - A Pilot Study
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:
Read more
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.
Read the detailed description
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.
- Conditions
- MDD, Severe Depression, Major Depressive Episode
- Being tested
- tDCS
- Keywords
- Non Invasive Brain Stimulation (NIBS), tDCS, at-home treatment, tdcs at home, transcranial direct current stimulation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| at home tdcs after ECT, rTMS or Esketamine treatment | Active comparator | 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. Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks from baseline
Secondary outcomes (4)
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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: These parameters will be assessed daily during treatment period, i.e. tDCS treatment day 1-20 automatically
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Oct 2024
- Primary completion29 Aug 2026 (estimated)
- Study completion29 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, pilot trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrike Vogelmann, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269964
- Sponsor's protocol ID
- RWNM_tDCS_Maintenance
- Acronym
- MaintenanceDC
- Status last verified
- Nov 2025
- First submitted
- 8 Sep 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All anonymised study outcomes will be shared, including questionnaire, physiological, and device data.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- At-home tDCS as Maintenance Therapy Following Successful Treatment With rTMS, ECT, and Esketamine - A Pilot Study
- ClinicalTrials.gov ID
- NCT07269964
- Acronym / sponsor ID
- MaintenanceDC / RWNM_tDCS_Maintenance
- Conditions
- MDD, Severe Depression, Major Depressive Episode
- Keywords
- Non Invasive Brain Stimulation (NIBS), tDCS, at-home treatment, tdcs at home, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 29 Aug 2026 (estimated)
- Study completion
- 29 Nov 2026 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, pilot trial
| Arm | Type | Receives |
|---|---|---|
| at home tdcs after ECT, rTMS or Esketamine treatment | Active comparator | Device: tDCSTranscranial 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSDescription: 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. | Device | at home tdcs after ECT, rTMS or Esketamine treatment |
Primary outcome
Feasibility, number of completed sessions
Time frame: 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.
4 secondary outcomes
Depressive Symptoms assessed with MADRS
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
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
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
Time frame: These parameters will be assessed daily during treatment period, i.e. tDCS treatment day 1-20 automatically
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: Yes. All anonymised study outcomes will be shared, including questionnaire, physiological, and device data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with MDD and Severe Depression, run by Technical University of Munich at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ulrike Vogelmann, Dr. med. (+4917661535471, ulrike.vogelmann@mri.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility, number of completed sessions (time frame: 4 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.