Home-based tDCS for depression: comparing treatment done at home vs in hospital

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial compares at-home versus hospital-based tDCS delivered over 20 sessions for adults with a depressive episode. Participants are randomized to home use with remote monitoring or to receive care in a hospital setting, with daily sessions proposed at 2 mA. Regular clinical monitoring and follow-up interviews help ensure safety and adherence. The primary goal is to show non-inferiority of home-based tDCS in reducing depressive symptoms at six weeks. Outcomes will include symptom change, safety monitoring, and feasibility data.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU de Nantes
  Nantes, France Recruiting
• Clinique Mirambeau
  Anglet, France Not yet recruiting
• CH Georges Mazurelle
  La Roche-sur-Yon, France Not yet recruiting
• CHU de Nîmes
  Nîmes, France Not yet recruiting
• CH Le Rouvray
  Sotteville-lès-Rouen, France Not yet recruiting
• CH Léon-Jean Grégory - Thuir
  Thuir, France Not yet recruiting

Study contacts

• Study coordinator: Damiens Choneau
• Email: bp-prom-regl@chu-nantes.fr
• Phone: 02 53 48 28 35

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.