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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS active comparator | Experimental | Active transcranial Direct Current Stimulation (tDCS): Stimulation of 1.5 mA for 30 minutes. |
|
| tDCS sham comparator | Sham Comparator | Sham transcranial Direct Current Stimulation (tDCS): Effective stimulation of 1.5 mA for 30 seconds, then the current is switched off. The complete session lasts 30 minutes, with 29 minutes and 30 seconds without stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active transcranial direct current stimulation (tDCS) | Device | Description of the tDCS session:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The primary outcome measure is the net score on the Iowa Gambling Task over 100 selections. This score represents the difference between the number of selections from low-risk and long-term advantageous decks and the number of selections from high-risk and long-term disadvantageous decks during 100 selections. This score ranges from -100 to 100, and the lower the score, the riskier the decision-making. This measurement will be taken immediately before and after tDCS stimulation. | Day 1 (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| To assess whether the change in decision-making under tDCS stimulation is independent of emotional changes (sadness). | PANAS : Positive and Negative Affect Schedule. Positive Affect Score range from 10 - 50, with higher scores representing higher levels of positive affect Negative Affect Score range from 10 - 50, with lower scores representing lower levels of negative affect. | Day 1 (end of study) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michel DANON, MD | Contact | +33625201929 | m.danon@ghu-paris.fr | |
| Fabrice JOLLANT, MD PhD | Contact | jollantf@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Michel DANON, MD | GHU Paris Pyschiatrie & Neurosciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GHU Paris Psychiatrie et Neurosciences - Hôpital Sainte-Anne - CMME | Recruiting | Paris | 75014 | France |
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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.
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The patients and the outcome assessor are blinded to the type of treatment received.
Each patient, at the end of the study, will be asked to guess whether the treatment received was active or sham.
|
| Sham transcranial direct current stimulation (tDCS) | Device | Description of the tDCS session:
|
|
| To assess whether the change in decision-making under tDCS stimulation is independent (STAI:State-Trait Anxiety Inventory) | STAI score range from 20 to 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80). These measurements will be taken immediately before and after tDCS stimulation. | Day 1 (end of study) |
| To assess whether tDCS stimulation of the OFC improves motor inhibition compared to placebo stimulation (Sustained-Attention test: d2-test) | d2-test: the test taker is required to scan the lines and cross out all occurrences of the letter 'd' with two dashes while ignoring all other characters. During the test, the subject must delete as many 'd2' as possible in 20 seconds per line (there are 14 lines on the sheet). This measurement will be taken immediately before and after tDCS stimulation. | Day 1 (end of study) |
| To assess whether tDCS stimulation of the OFC improves reduces susceptibility to interference compared to placebo stimulation. | Emotional stroop task : Difference in reaction time. The higher the score, the greater the susceptibility to interference. This measurement will be taken immediately before and after tDCS stimulation. | Day 1 (end of study) |
| To assess whether tDCS stimulation of the OFC improves cognitive inhibition compared to placebo stimulation. | Go-no go task : Commission error rate. The lower the score, the more effective cognitive inhibition is. This measurement will be taken immediately before and after tDCS stimulation. | Day 1 (end of study) |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D003863 | Depression |
| D013405 | Suicide |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D016728 | Self-Injurious Behavior |
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