Actively Recruiting
At-home tDCS as Maintenance Therapy Following Successful Treatment With rTMS, ECT, and Esketamine - A Pilot Study
Led by Technical University of Munich · Updated on 2025-12-08
30
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a home-based transcranial direct current stimulation (tDCS) program as a maintenance therapy for adults with depressive disorders who have already improved or stabilized after acute inpatient treatment such as esketamine, repetitive transcranial magnetic stimulation (rTMS), or electroconvulsive therapy (ECT). This pilot study aims to determine if the home tDCS program is practical, well tolerated, and shows early signs of maintaining clinical benefits obtained from prior treatments. Participants receive a portable tDCS device with a cap and sponge electrodes to use at home for 20 sessions over 4 weeks, each session lasting 30 minutes at a low current of 2 mA, five times per week. The device gradually ramps the current up and down for comfort and automatically pauses if electrode contact is poor. Participants also use a smartphone app that provides guidance, reminders, and automatically logs sessions. Throughout the treatment, participants complete weekly self-rating questionnaires and have brief phone check-ins every two weeks, followed by a 2-week follow-up period after completing the 4-week program. During the study, researchers monitor how many treatment sessions participants complete, assess depressive symptoms using clinician-rated and self-reported scales such as MADRS and BDI-II, and track any adverse events or device-related issues. The device ensures safety by monitoring electrode contact and pausing if necessary. Data are stored anonymously in the app for clinical team review via a secure portal. The total participation includes 4 weeks of home treatment and a 2-week follow-up, focusing on feasibility, safety, adherence, and preliminary effectiveness of the tDCS maintenance program.
CONDITIONS
Brief Title
At-Home tDCS as Maintenance Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (18 years or older).
- Diagnosis of recurrent depressive disorder, severe depressive disorder, schizoaffective disorder (depressive episode), or bipolar affective disorder (depressive episode) according to ICD-10.
- Clear indication for maintenance therapy after successful acute treatment (esketamine, rTMS, or ECT) with remission or improvement of symptoms.
- Ability to provide informed consent confirmed by a physician-led discussion.
You will not qualify if you...
- Currently in the acute treatment phase of an affective disorder with non-response to previous treatments.
- Presence of clinically relevant Axis II disorders.
- Suicidal risk, including suicidal ideation.
- Contraindications for tDCS such as skin disease at electrode sites or cochlear implants.
- Neurological, somatic, or psychiatric comorbidities that could affect study validity or safety.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive standardized instruction on using the portable tDCS device, including correct electrode placement and skin preparation.
1 visit (in-person)
Duration - 4 weeks
Participants complete 20 at-home tDCS sessions over 4 weeks, with 5 sessions per week, each session lasting 30 minutes at 2 mA.
Weekly questionnaires and check-ins every 2 weeks during treatment
Duration - 2 weeks
Participants complete a 2-week follow-up period with a final assessment to evaluate maintenance of clinical benefits and safety.
1 final assessment visit
Trial Site Locations
Total: 2 locations
1
Technical University of Munich, TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy, Munich,
München, Bavaria, Germany, 81675
Enrolling by Invitation
2
Department of Psychiatry and Psychotherapy, Technical University of Munich, University Hospital
München, Germany, 81675
Actively Recruiting
Research Team
U
Ulrike Vogelmann, Dr. med.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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