RecruitingNot ApplicableNCT07490379

Comparison of the Efficacy of Transcranial Direct Current Stimulation at Home Versus in Hospital Settings in Patients With Depressive Episodes

CAPUCINOO - Comparison of the Efficacy of Transcranial Direct Current Stimulation at Home Versus in Hospital Settings in Patients With Depressive Episodes: Non-inferiority Study, the Impact of Nursing Follow-up and Implementation of the Care Pathway


Sponsor

Nantes University Hospital

Enrollment

66 participants

Start Date

Jul 31, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Distribution of study questionnaires, Monitoring tDCS appropriation, and others for people with depression. The study is currently recruiting participants at 6 locations.

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

OTHERDistribution of study questionnaires

The questionnaires will be administered to patients at DO, D10, and M2. MADRS/RSES/EQ-5D-5L/BDI/CRQ

OTHERtDCS sessions (D1-D10)

Protocol: 2 mA, 30 min, 10 working days (Monday to Friday), 2 sessions/day

OTHERMonitoring tDCS appropriation

During visits to the hospital, the nurse ensures that the patient knows how to use the device correctly.

OTHERSemi-structured interviews with patients

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.


Locations(6)

Clinique Mirambeau

Anglet, France

CH Georges Mazurelle

La Roche-sur-Yon, France

CHU de Nantes

Nantes, France

CHU de Nîmes

Nîmes, France

CH Le Rouvray

Sotteville-lès-Rouen, France

CH Léon-Jean Grégory - Thuir

Thuir, France

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NCT07490379


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