Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07490379
NA

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

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

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

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.

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