At-Home tDCS as Maintenance Therapy

NCT07269964 | Recruiting

• 1 other identifier: RWNM_tDCS_Maintenance
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Non Invasive Brain Stimulation (NIBS); tDCS; at-home treatment; tdcs at home; transcranial direct current stimulation

Outcome Measures

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.

  4 weeks from baseline

Secondary Outcomes (4)

• Depressive Symptoms assessed with MADRS

  MADRS: Measured in week one, week two, week four during treatment phase and in week six during the follow up phase.

• BDI II

  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

  Adverse events are monitored weekly: Baseline (pre-treatment), week 1, 2, 3, 4 and during follow up (week 6)

• Analysis of monitored technical parameters

  These parameters will be assessed daily during treatment period, i.e. tDCS treatment day 1-20 automatically

Study Arms (1)

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.

Device: tDCS

Interventions

tDCS DEVICE

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.

at home tdcs after ECT, rTMS or Esketamine treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (2)

Technical University of Munich, TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy, Munich,

München, Bavaria, 81675, Germany

ENROLLING BY INVITATION

Department of Psychiatry and Psychotherapy, Technical University of Munich, University Hospital

München, 81675, Germany

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Ulrike Vogelmann, Dr. med.

CONTACT

+4917661535471; ulrike.vogelmann@mri.tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.med.

Model Details: Single arm, pilot trial

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: December 8, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): August 29, 2026
• Study Completion (Estimated): November 29, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: IPD and supporting information will be made available immediately after the publication of study results, for an unrestricted duration.
• Access Criteria: The de-identified individual patient data, i.e., all IPD that underlie results in a publication, will be made accessible after its publication for non-commercial academic projects that have a legitimate research topic and a clearly stated hypothesis. In the event that the application is accepted, researchers will be asked to get the study approved by their institution's ethics board. The study principal investigator will subsequently provide the de-identified data sets via a safe data transfer system.

Locations

DE (2)