At-Home tDCS as Maintenance Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTechnical University of Munich
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
tDCS
DeviceDescription: 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: at home tdcs after ECT, rTMS or Esketamine treatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 baselineSecondary outcomes
1
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.2
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 6.3
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)4
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 automaticallySponsors and contacts
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Source ClinicalTrials.gov