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.
Men or women over the age of 18
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
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
Parallel
Distribution of study questionnaires
Other interventionThe questionnaires will be administered to patients at DO, D10, and M2. MADRS/RSES/EQ-5D-5L/BDI/CRQ
tDCS sessions (D1-D10)
Other interventionProtocol: 2 mA, 30 min, 10 working days (Monday to Friday), 2 sessions/day
Monitoring tDCS appropriation
Other interventionDuring visits to the hospital, the nurse ensures that the patient knows how to use the device correctly.
Semi-structured interviews with patients
Other interventionThe interviews will be conducted by telephone with patients participating in the study. The purpose of these interviews is to gather information for the qualitative aspect of the implementation.
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).
The scale ranges from 0 to 60, with 60 representing the worst possible outcome.
Evaluate the response to treatment by comparing the two arms immediately post-treatment and at M2 (6 weeks post-treatment). This will be assessed by the change in the total MADRS scale score.
The scale ranges from 0 to 60, with 60 representing the worst possible outcome.
Evaluate the remission rate in each of the two arms immediately after treatment and at M2.
Compare the change in patient self-reported depressive symptoms using the BDI-II (Beck Depression Inventory-II) in both study arms, measured immediately post-treatment and at M2 (6 weeks post-treatment).
The scale ranges from 0 to 3, where 3 representing the worst possible outcome.
Assess the impact of tDCS on self-esteem using the Rosenberg Self-Esteem Scale (RSES) in both study arms, measured immediately post-treatment and at M2 (6 weeks post-treatment).
The scale ranges from 1 to 4, where 1 indicates "strongly disagree" and 4 indicates "strongly agree.
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Nantes University Hospital
Lead sponsor
Direction Générale de l'Offre de Soins
Collaborator
Sooma Medical
Collaborator