At-Home tDCS as Maintenance Therapy

Recruiting now · Not applicable

Conditions studied: MDD, Severe Depression, Major Depressive Episode

In brief

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.

Key facts

Study ID

NCT07269964

Run by

Technical University of Munich

People needed

30

Starts

2024-10-01

Expected to finish

2026-11-29

Last updated by the study team

2025-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Department of Psychiatry and Psychotherapy, Technical University of Munich, University Hospital — München, Germany (enrolling)
• Technical University of Munich, TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy, Munich, — München, Bavaria, Germany

Full record on ClinicalTrials.gov

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