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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression
• Intervention / Treatment: Other: Distribution of study questionnaires; Other: tDCS sessions (D1-D10); Other: Semi-structured interviews with patients; Other: Monitoring tDCS appropriation

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Damiens Choneau; Phone Number: +33 02 53 48 28 35; Email: bp-prom-regl@chu-nantes.fr

Study Locations

• France
  • Anglet, France
    • Clinique Mirambeau
    • Contact: Christophe DAUDET; Phone Number: +33 5 59 52 33 00; Email: cdaudet001@gmail.com
    • Principal Investigator: Christophe DAUDET
  • La Roche-sur-Yon, France
    • CH Georges Mazurelle
    • Contact: Cathy LONGUECHAUD; Phone Number: +33 2 51 09 72 72; Email: Cathy.longuechaud@ch-mazurelle.fr
    • Principal Investigator: Cathy LONGUECHAUD
  • Nantes, France
    • CHU de Nantes
    • Contact: Damiens CHONEAU; Phone Number: +33 2 44 76 83 70; Email: damiens.choneau@chu-nantes.fr
    • Principal Investigator: Damiens CHONEAU
  • Nîmes, France
    • CHU de Nîmes
    • Contact: Antoine GIRON; Phone Number: +33 6 29 84 30 73; Email: antoine.giron@chu-nimes.fr
    • Principal Investigator: Antoine GIRON
  • Sotteville-lès-Rouen, France
    • CH Le Rouvray
    • Contact: Marie-Laure MILLET; Phone Number: +33 2 32 95 68 25; Email: Marie-Laure.MILLET@ch-lerouvray.fr
    • Principal Investigator: Marie-Laure MILLET
  • Thuir, France
    • CH Léon-Jean Grégory - Thuir
    • Contact: Philippe RAYNAUD DE PRIGNY; Phone Number: +33 4 68 84 66 10; Email: Philippe.Raynaud@ch-thuir.fr
    • Principal Investigator: Philippe RAYNAUD DE PRIGNY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men or women over the age of 18

• Psychiatric diagnosis:

  • Presenting a depressive episode characterised according to DSM-5 criteria
  • MADRS score greater than or equal to 20, indicating moderate to severe depression
  • Indication and prescription of a course of tDCS treatment consisting of 20 sessions of 30 minutes at 2mA, at a rate of 2 sessions per day

• Drug treatment:

  o Failure of a maximum of 1 or 2 antidepressants taken successively or in combination for the current episode

• Psychiatric follow-up: Receiving medical follow-up by a psychiatrist or referring physician

• Ability to understand and cooperate:

  • Having a smartphone, computer or tablet (with internet connection and Bluetooth) to use the digital interface required to perform remote tDCS
  • Be deemed capable of understanding the nature of the study and participating in clinical follow-up
• Informed consent: Have given written consent to participate in the research, after receiving oral and written information about the study.
• Social affiliation: Be affiliated with a social security system

Exclusion Criteria:

• Psychiatric or neurological diagnoses:

  • Chronic psychotic disorders or history of schizophrenia
  • Progressive neurological disorders (unstabilised epilepsy, brain tumour, recent stroke, severe head injury)

• History or current treatment of neuromodulation

  • Any history of tDCS treatment, whether carried out in a clinical or research setting
  • Current treatment or history of rTMS and ECT sessions for the current episode
  • Presence of an active vagus nerve stimulation implant
• Presence of a high risk of suicide. A risk of suicide will be considered high if the score on item 10 of the MADRS scale ("Suicidal Thoughts") is 4 or higher, and/or if there is active suicidal ideation accompanied by clinically identified intent or a plan
• Addiction and substance use: Current substance use disorder other than nicotine or caffeine
• Psychiatric comorbidities that may interfere with study participation, including: understanding information, adherence to the protocol, and completing CBT sessions.
• Recent change in curative psychotropic treatment (antidepressant, mood stabiliser including lithium and anticonvulsants, mood-stabilising antipsychotic) in the month prior to inclusion.

• Medical contraindication to stimulation:

  • Presence of a metallic or electronic implant in the skull or chest (pacemaker, neurostimulator, cochlear implant)
  • Skin lesion, irritation or wound on the electrode contact areas
  • History of epileptic seizures not related to an identified cause or not stabilised for more than 12 months
  • Current pregnancy or breastfeeding
  • Women of childbearing age without effective contraception (hormonal or medical device)
• A severe and/or progressive somatic condition requiring ongoing medical care that would interfere with participation in the study.

• Limited ability to participate:

  • A significant cognitive impairment or sensory deficit that prevents understanding of instructions

  • Inability to safely perform tDCS at home, as defined by at least one of the following:

    • inability to understand or recall essential instructions regarding procedure and safety;
    • inability to perform, following initial guidance, the essential steps for setting up and starting the device;
    • lack of the minimum material conditions required at home to conduct the sessions.

• Special legal or social situation:

  • Patients under guardianship, curatorship or judicial protection
  • Privation of liberty by judicial or administrative decision, Presence of a functional limitation to the independent performance of tDCS

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: tDCS at the hospital; 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; 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: 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.
Experimental: Performing tDCS at home; 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; 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: 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.; Other: Monitoring tDCS appropriation; During visits to the hospital, the nurse ensures that the patient knows how to use the device correctly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 Months
Evaluate the remission rate in each of the two arms immediately after treatment and at M2.		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.	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.	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.	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.	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.	2 months
Analyse the financial impact of the rollout of tDCS at home (budget impact analysis over 5 years)		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.	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.	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.	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.	2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Implementation Costs (microcosting).		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.	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)		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)		2 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Direction Générale de l'Offre de Soins; Sooma Medical

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 10, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Implementation; Care pathway; Direct transcranial direct current stimulation; Nursing follow-up
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: RC25_0344; 2026-A00335-46 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No