Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT06110559
Status:
UNKNOWN
Last Update Posted:
2023-11-02
First Post:
2023-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of tDCS Applied to the Orbitofrontal Cortex to Improve Risky Decision-making in a Clinical Population
Sponsor:
Centre Hospitalier St Anne
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
tDCSDeMOStim
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: