RecruitingNot ApplicableNCT07269964

At-Home tDCS as Maintenance Therapy

At-home tDCS as Maintenance Therapy Following Successful Treatment With rTMS, ECT, and Esketamine - A Pilot Study


Sponsor

Technical University of Munich

Enrollment

30 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a wearable brain stimulation device used at home can help people with depression or bipolar disorder stay well after they've responded to treatment. The device delivers a mild electrical current to the forehead (called tDCS) to support ongoing mental health. **You may be eligible if...** - You are 18 or older - You have been diagnosed with recurrent depression, severe depression, schizoaffective disorder (depressive type), or bipolar disorder (depressive episode) - Your doctor has recommended maintenance therapy after you responded well to an initial course of tDCS treatment - You are able to use a home device with guidance **You may NOT be eligible if...** - You have metal implants in your head or a pacemaker - You are currently in a severe depressive or manic episode - You have a seizure disorder or significant neurological condition - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEtDCS

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.


Locations(2)

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

München, Bavaria, Germany

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

München, Germany

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NCT07269964


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