Home-based Non-invasive Brain Stimulation for Treatment-resistant Depression Feasibility, Efficacy and Biomarker of Treatment Response
Spain40 participantsStarted 2023-06-15
Plain-language summary
Depression has a yearly prevalence superior to 5%, but a 30% of patients cannot benefit of pharmacological treatment, resulting resistant to it.
Transcranial direct current stimulation, due to its reduced invasiveness and easy administration showed to be a useful technique to treat these cases, and it is now broadly used in clinical practice.
Moreover, thanks to technological advances, this treatment could be self-administered at home, reducing costs and improving scalability.
The aim of this study is to confirm the efficacy, safety and feasibility of a home-based intervention for treatment-resistant depression
To do this participants will perform a home-based tDCS intervention consisting of 30 minutes sessions, 5 days per week, for 4 weeks.
Results should provide critical knowledge regarding home-based therapies for the treatment of resistant depression and evidence on brain mechanisms underlying response to non-invasive brain stimulation.
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:
* Meet criteria and be diagnosed by a Psychiatrist for MDD, according to the Diagnostic and Statistical Manual of Mental Disorders
* Score at least 20 on the Montgomery-Åsberg Depression Rating Scale
* Be stable enough to participate in the study without risk for safety.
* Live with an adult with computer skills and willingness to learn how to use tDCS.
Exclusion criteria:
* Present other psychiatric conditions or neurological disorders
* Abuse of alcohol or drugs
* Pregnancy
* Present any contraindication for tDCS
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
Adherence
Timeframe: immediately after the intervention
2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]