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

N/ANot Yet RecruitingNCT07490379

Nantes University Hospital66 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Depression

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 * High risk of suicide as assessed by the psychiatrist * Addiction and substance use: Current substance use disorder other than nicotine or caffeine * Current psychiatric comorbidity that may interfere with participation in the study, as assessed by the investigator. * 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) * Medical comorbidities: Severe and/or progressive somatic pathology as assessed by the patient's referring psychiatrist. * Reduced ability to participate: * Major cognitive impairment or sensory deficit preventing understanding of instructions * Inability to operate the tDCS device or lack of safe conditions at home, as assessed by the investigator. * 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

Outcomes

Primary Outcomes

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.

Time frame: 2 months

Secondary Outcomes

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.

Time frame: 2 Months

Evaluate the remission rate in each of the two arms immediately after treatment and at M2.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 2 months

Analyse the financial impact of the rollout of tDCS at home (budget impact analysis over 5 years)

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 2 months

Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Implementation Costs (microcosting).

Time frame: 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.

Time frame: 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)

Time frame: 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)

Time frame: 2 months

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

Overview

Conditions

Interventions

Eligibility

Locations (6)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts