An interventional study of Distribution of study questionnaires and tDCS sessions (D1-D10) in Depression, sponsored by Nantes University Hospital. Recruiting at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Other
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 66 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
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Psychiatric diagnosis:
Drug treatment:
o Failure of a maximum of 1 or 2 antidepressants taken successively or in combination for the current episode
Ability to understand and cooperate:
Exclusion Criteria:
Psychiatric or neurological diagnoses:
History or current treatment of neuromodulation
Medical contraindication to stimulation:
Limited ability to participate:
Inability to safely perform tDCS at home, as defined by at least one of the following:
Special legal or social situation:
In the control group, patients receive tDCS treatment at the hospital under nursing supervision. In the control group, patients receive tDCS treatment at the hospital under nursing supervision.
Other: Distribution of study questionnaires · Other: tDCS sessions (D1-D10) · Other: Semi-structured interviews with patients
As part of the home intervention group, patients undergo a self-administered tDCS treatment, but under remote nursing supervision via the SoomaDuo app (CE marked, used in accordance with the tDCS device). This device allows daily monitoring of treatment, automatic verification of stimulation parameters and complete traceability of compliance.
Other: Distribution of study questionnaires · Other: tDCS sessions (D1-D10) · Other: Monitoring tDCS appropriation · Other: Semi-structured interviews with patients
The questionnaires will be administered to patients at DO, D10, and M2. MADRS/RSES/EQ-5D-5L/BDI/CRQ
Protocol: 2 mA, 30 min, 10 working days (Monday to Friday), 2 sessions/day
During visits to the hospital, the nurse ensures that the patient knows how to use the device correctly.
The 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.
Time frame: 2 months
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.
Time frame: 2 Months
Evaluate the remission rate in each of the two arms immediately after treatment and at M2.
Time frame: 2 months
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.
Time frame: 2 months
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.
Time frame: 2 months
Study patients' quality of life using the EQ-5D-5L after tDCS treatment in each of the two arms immediately after treatment and at M2.
The scale ranges from 0 to 100, with 0 representing the worst possible outcome.
Time frame: 2 months
Assess the safety of the two tDCS administration modalities using the Comfort Rating Questionnaire (CRQ) in each of the two arms immediately after treatment.
The scale ranges from 0 to 10, with 10 representing the worst possible outcome.
Time frame: 10 Days
Compare efficiency from a collective perspective and over a two-month time horizon.
Incremental cost-utility ratio (cost per QALY) at 2 months.
Time frame: 2 months
Analyse the financial impact of the rollout of tDCS at home (budget impact analysis over 5 years)
Time frame: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Relevance
Qualitative analysis of data collected during semi-structured interviews with patients and their relatives regarding the suitability or unsuitability of the method of administering tDCS at home.
Time frame: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Acceptability
* Proportion of reasons for refusal among patients identified but not included following a log-based screening process, linked to a negative perception of tDCS. * Number of patients reporting discomfort during stimulation * Number of patients who withdrew after randomisation due to a negative experience of tDCS.
Time frame: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Fidelity
Ratio of the number of sessions completed to the number of sessions planned in each of the two groups. // Proportion of patients who discontinued the protocol before completion // Factors leading to deviations that resulted in the treatment being carried out over a longer period or in the tDCS stimulation treatment being discontinued.
Time frame: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Adoption
Proportion of individuals included among those identified. Description of the reasons for excluding patients who were identified but not included. Frequency of inclusions.
Time frame: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Implementation Costs (microcosting).
Time frame: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Feasibility
Number of patients who completed the full course of tDCS treatment.
Time frame: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain: Reach (Sociodemographic profile of the patients included)
Time frame: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Sustainability (Integration of the scheme into the facility's care programme)
Time frame: 2 months
Plan to share: Undecided
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Nantes University Hospital