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At-Home tDCS as Maintenance Therapy

NCT07269964 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-08

No results posted yet for this study

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 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.

Conditions

  • MDD
  • Severe Depression
  • Major Depressive Episode

Interventions

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.

Sponsors & Collaborators

  • Technical University of Munich

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2026-08-29
Completion
2026-11-29

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07269964 on ClinicalTrials.gov