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

NCT07490379 | Not Yet Recruiting

• 2 other identifiers: RC25_03442026-A00335-46
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Depression; Direct transcranial direct current stimulation; Nursing follow-up; Implementation; Care pathway

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• 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.

  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).

  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).

  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.

  2 months

Study Arms (2)

tDCS at the hospital

ACTIVE COMPARATOR

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; Other: tDCS sessions (D1-D10); Other: Semi-structured interviews with patients

Performing tDCS at home

EXPERIMENTAL

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; Other: tDCS sessions (D1-D10); Other: Monitoring tDCS appropriation; Other: Semi-structured interviews with patients

Interventions

Distribution of study questionnaires OTHER

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

Performing tDCS at home; tDCS at the hospital

tDCS sessions (D1-D10) OTHER

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

Performing tDCS at home; tDCS at the hospital

Monitoring tDCS appropriation OTHER

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

Performing tDCS at home

Semi-structured interviews with patients OTHER

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.

Performing tDCS at home; tDCS at the hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Direction Générale de l'Offre de Soins: collaborator
• Nantes University Hospital: lead
• Sooma Medical: collaborator

Study Sites (6)

Clinique Mirambeau

Anglet, France

Location

CH Georges Mazurelle

La Roche-sur-Yon, France

Location

CHU de Nantes

Nantes, France

Location

CHU de Nîmes

Nîmes, France

Location

CH Le Rouvray

Sotteville-lès-Rouen, France

Location

CH Léon-Jean Grégory - Thuir

Thuir, France

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Damiens Choneau

CONTACT

02 53 48 28 35; bp-prom-regl@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 24, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 10, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

FR (6)