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Comparison of the Efficacy of Transcranial Direct Current Stimulation at Home Versus in Hospital Settings in Patients With Depressive Episodes
Sponsor: Nantes University Hospital
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2026-06-01
Completion Date
2028-02-01
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
Distribution of study questionnaires
The questionnaires will be administered to patients at DO, D10, and M2. MADRS/RSES/EQ-5D-5L/BDI/CRQ
tDCS sessions (D1-D10)
Protocol: 2 mA, 30 min, 10 working days (Monday to Friday), 2 sessions/day
Monitoring tDCS appropriation
During visits to the hospital, the nurse ensures that the patient knows how to use the device correctly.
Semi-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