Comparison of the Efficacy of Transcranial Direct Current Stimulation at Home Versus in Hospital … (NCT07490379) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of the Efficacy of Transcranial Direct Current Stimulation at Home Versus in Hospital Settings in Patients With Depressive Episodes
France66 participantsStarted 2026-06-01
Plain-language summary
Transcranial direct current stimulation (tDCS) is a neuromodulation method that modulates brain activity using low-intensity electrical current. Used in the treatment of depression, it is easily adaptable for both caregivers and patients, with good tolerance, under appropriate supervision.
Allowing patients to perform tDCS at home could address issues of access to care (distance from home, overall cost of care, lack of healthcare professionals, difficulty travelling for physical/psychological reasons, etc.). Studies on tDCS have highlighted the importance of regular clinical monitoring to ensure compliance and safety, which are essential factors for therapeutic efficacy.
The main objective of this study is to demonstrate the non-inferiority of tDCS performed at home versus in hospital in terms of effectiveness in reducing depressive symptoms at 6 weeks post-treatment in patients with moderate to severe depression.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men or women over the age of 18
* Psychiatric diagnosis:
* Presenting a depressive episode characterised according to DSM-5 criteria
* MADRS score greater than or equal to 20, indicating moderate to severe depression
* Indication and prescription of a course of tDCS treatment consisting of 20 sessions of 30 minutes at 2mA, at a rate of 2 sessions per day
* Drug treatment:
o Failure of a maximum of 1 or 2 antidepressants taken successively or in combination for the current episode
* Psychiatric follow-up: Receiving medical follow-up by a psychiatrist or referring physician
* Ability to understand and cooperate:
* Having a smartphone, computer or tablet (with internet connection and Bluetooth) to use the digital interface required to perform remote tDCS
* Be deemed capable of understanding the nature of the study and participating in clinical follow-up
* Informed consent: Have given written consent to participate in the research, after receiving oral and written information about the study.
* Social affiliation: Be affiliated with a social security system
Exclusion Criteria:
* Psychiatric or neurological diagnoses:
* Chronic psychotic disorders or history of schizophrenia
* Progressive neurological disorders (unstabilised epilepsy, brain tumour, recent stroke, severe head injury)
* History or current treatment of neuromodulation
* Any history of tDCS treatment, whether carried out in a clinical or research setting
* Current trea…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the non-inferiority of tDCS administered at home compared to in-hospital treatment in terms of effectiveness in reducing depressive symptoms 6 weeks post-treatment, using the MADRS (Montgomery-Asberg Depression Rating Scale).