NCT07490379

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression

Interventions

Type	Name	Description
OTHER	Distribution of study questionnaires	The questionnaires will be administered to patients at DO, D10, and M2. MADRS/RSES/EQ-5D-5L/BDI/CRQ
OTHER	tDCS sessions (D1-D10)	Protocol: 2 mA, 30 min, 10 working days (Monday to Friday), 2 sessions/day
OTHER	Monitoring tDCS appropriation	During visits to the hospital, the nurse ensures that the patient knows how to use the device correctly.
OTHER	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.

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-12-10
• Completion: 2028-02-01
• First posted: 2026-03-24
• Last updated: 2026-03-31

Locations

6 sites across 1 country: France