Clinical trial NCT06110559: Use of tDCS Applied to the Orbitofrontal Cortex to Improve Risky Decision-making in a Clinical Population
Official title: Use of tDCS (Transcranial Direct Current Stimulation) Applied to the Orbitofrontal Cortex to Improve Risky Decision-making in a Clinical Population: a Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mood Disorders
Depression
Suicide
Keywords: Endophenotype
Transcranial Direct Current Stimulation
Cognition
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective monocentric interventional randomised controlled trial vs placebo (sham tDCS) in 2 parallel groups.

An interim analysis focusing on the primary objective will be performed when at least 50% of the total expected sample has completed the study.
Primary purpose: TREATMENT

Brief summary: Decision-making is a complex cognitive function that has been the subject of extensive scientific research in the fields of cognitive and computational neuroscience. It relies on a cerebral network that encompasses cortico-subcortical pathways. The orbitofrontal cortex (OFC) plays a significant role in decision-making by assigning values to guide choices. Risky decision-making is observed in several psychiatric pathologies, including depression and bipolar disorder, and it may constitute an endophenotype of suicide. In the project presented here, we propose to use transcranial direct current stimulation (tDCS) to target decision-making in patients suffering from mood disorders.

Detailed description: The primary objective is to assess the ability of tDCS applied to the orbitofrontal cortex to improve decision-making, as measured by the Iowa Gambling Task, compared to a placebo stimulation in patients suffering from mood disorders.

The secondary objectives are as follows:

* To assess whether the evolution of decision-making under tDCS stimulation is independent of emotional changes (sadness, anxiety).
* To evaluate if tDCS stimulation of the orbitofrontal cortex improves motor inhibition, assessed using the D2-test, compared to a placebo stimulation.
* To determine if tDCS stimulation of the orbitofrontal cortex reduces sensitivity to interference, assessed with the Stroop test, compared to a placebo stimulation.
* To evaluate if tDCS stimulation of the orbitofrontal cortex enhances cognitive inhibition, measured by the Go-no go test, compared to a placebo stimulation.

This is a prospective monocentric interventional randomised controlled trial with two parallel groups, one receiving active treatment with tDCS and the other receiving a placebo (sham tDCS). The randomization will be performed in variable-sized blocks and will be stratified based on the current mood state (current depression versus current euthymia). It is a single-blind study where the patients and the outcome assessor are blinded to the type of treatment received.

Recruitment will take place at "la Clinique des Maladies Mentales et de l'Encéphale de l'Hôpital Sainte-Anne" and will involve hospitalized patients as well as those in outpatient care. Pre-inclusion visit involve patient selection, verification of inclusion criteria, and the provision of information documents. Inclusion visit occur at least one day later, lasting for three hours. It involves the verification of both inclusion and exclusion criteria, obtaining informed consent, randomization, collecting socio-medical-demographic data, and conducting psychometric and neuropsychological assessments. Stimulation visit, also scheduled at least one day later and lasting three hours, encompass the measurement of primary and secondary evaluation criteria immediately before and after tDCS stimulation. A group guessing test concludes the study.

An interim analysis is planned, and an Independent Data Monitoring Committee (IDMC) will be established to oversee the data.

Eligibility criteria: Inclusion Criteria:

* Patients under consideration should either be receiving outpatient or inpatient care.
* Patients must be between the ages of 18 and 65, inclusive.
* According to DSM-5 criteria, patients should be diagnosed with either unipolar or bipolar depressive disorder. This includes individuals currently experiencing a characterized depressive episode with mild to moderate intensity, those in partial remission, or those in full remission.
* Patients must have provided informed consent.
* Patients should be enrolled in a social security plan.

Exclusion Criteria:

* Patient unwilling to participate in the research.
* Non-French-speaking individuals.
* Individuals deprived of liberty by judicial or administrative decision, such as those under guardianship or curatorship or involuntarily hospitalized.
* Pregnant or breastfeeding women.
* Current hypomanic or manic episode as per DSM-5 criteria due to motor agitation issues.
* Ongoing electroconvulsive therapy (ECT) treatment or within the last 6 months.
* Patients with active implantable medical devices.
* Epilepsy.

Primary outcomes:
measure: The study aims to assess the effectiveness of tDCS applied to the orbitofrontal cortex in enhancing decision-making abilities, as measured by the Iowa Gambling Task, when compared to placebo stimulation in patients with mood disorders.
timeFrame: Day 1 (end of study)
Secondary outcomes:
measure: To assess whether the change in decision-making under tDCS stimulation is independent of emotional changes (sadness).
timeFrame: Day 1 (end of study)
measure: To assess whether the change in decision-making under tDCS stimulation is independent (STAI:State-Trait Anxiety Inventory)
timeFrame: Day 1 (end of study)
measure: To assess whether tDCS stimulation of the OFC improves motor inhibition compared to placebo stimulation (Sustained-Attention test: d2-test)
timeFrame: Day 1 (end of study)
measure: To assess whether tDCS stimulation of the OFC improves reduces susceptibility to interference compared to placebo stimulation.
timeFrame: Day 1 (end of study)
measure: To assess whether tDCS stimulation of the OFC improves cognitive inhibition compared to placebo stimulation.
timeFrame: Day 1 (end of study)
Other outcomes:
Locations:
city: Paris
country: France
facility: GHU Paris Psychiatrie et Neurosciences - Hôpital Sainte-Anne - CMME
Study officials:
affiliation: GHU Paris Pyschiatrie & Neurosciences
name: Michel DANON, MD
role: PRINCIPAL_INVESTIGATOR
References: