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

October 31, 2023 updated by: Centre Hospitalier St Anne

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75014
        • Recruiting
        • GHU Paris Psychiatrie et Neurosciences - Hôpital Sainte-Anne - CMME
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michel DANON, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: tDCS active comparator
Active transcranial Direct Current Stimulation (tDCS): Stimulation of 1.5 mA for 30 minutes.
Device: Active transcranial direct current stimulation (tDCS)

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.
Sham Comparator: tDCS 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)

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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.
Time Frame: Day 1 (end of study)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To assess whether tDCS stimulation of the OFC improves reduces susceptibility to interference compared to placebo stimulation.
Time Frame: Day 1 (end of study)
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.
Time Frame: Day 1 (end of study)
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)
To assess whether the change in decision-making under tDCS stimulation is independent of emotional changes (sadness).
Time Frame: Day 1 (end of study)
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)
To assess whether the change in decision-making under tDCS stimulation is independent (STAI:State-Trait Anxiety Inventory)
Time Frame: Day 1 (end of study)

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)
Time Frame: Day 1 (end of study)

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier St Anne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michel DANON, MD, GHU Paris Pyschiatrie & Neurosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D20-P041

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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