Use of tDCS Applied to the Orbitofrontal Cortex to Improve Risky Decision-making in a Clinical Population

NCT06110559 | Unknown DMC

• 1 other identifier: D20-P041
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Mood Disorders; Depression; Suicide

Keywords

Endophenotype; Transcranial Direct Current Stimulation; Cognition

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• To assess whether the change in decision-making under tDCS stimulation is independent of emotional changes (sadness).

  Day 1 (end of study)

• To assess whether the change in decision-making under tDCS stimulation is independent (STAI:State-Trait Anxiety Inventory)

  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)

  Day 1 (end of study)

• To assess whether tDCS stimulation of the OFC improves reduces susceptibility to interference compared to placebo stimulation.

  Day 1 (end of study)

• To assess whether tDCS stimulation of the OFC improves cognitive inhibition compared to placebo stimulation.

  Day 1 (end of study)

Study Arms (2)

tDCS active comparator

EXPERIMENTAL

Active transcranial Direct Current Stimulation (tDCS): Stimulation of 1.5 mA for 30 minutes.

Device: Active transcranial direct current stimulation (tDCS)

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.

Device: Sham transcranial direct current stimulation (tDCS)

Interventions

Active transcranial direct current stimulation (tDCS) DEVICE

Description of the tDCS session: * Placement of conductive electrodes, attached to the scalp. The electrodes are placed in individual sponge cases moistened with a saline solution. A sponge towel is placed on the patient's shoulders to prevent any clothing from becoming damp. The electrodes are held in place by a dedicated net. * The anode is placed in the left supraorbital region (site Fp1 EEG 10/20 system). The cathode was placed in the right supraorbital region (site Fp2 EEG 10/20 system). * Patients received 1.5 mA stimulation for 30 minutes.

tDCS active comparator

Sham transcranial direct current stimulation (tDCS) DEVICE

Description of the tDCS session: * Placement of conductive electrodes, attached to the scalp. The electrodes are placed in individual sponge cases moistened with a saline solution. A sponge towel is placed on the patient's shoulders to prevent any clothing from becoming damp. The electrodes are held in place by a dedicated net. * The anode is placed in the left supraorbital region (site Fp1 EEG 10/20 system). The cathode was placed in the right supraorbital region (site Fp2 EEG 10/20 system). * Patients received effective stimulation of 1.5 mA for 30 seconds, after which the current was switched off. The entire session lasted 30 minutes, with 29 minutes and 30 seconds without stimulation.

tDCS sham comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (1)

GHU Paris Psychiatrie et Neurosciences - Hôpital Sainte-Anne - CMME

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Mood Disorders; Depression; Suicide

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Self-Injurious Behavior

Study Officials

• Michel DANON, MD

  GHU Paris Pyschiatrie & Neurosciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel DANON, MD

CONTACT

+33625201929; m.danon@ghu-paris.fr

Fabrice JOLLANT, MD PhD

CONTACT

jollantf@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 31, 2023
• Study Start: April 16, 2021
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: November 2, 2023

Record last verified: 2023-10

Locations

FR (1)