Mood DisorderstDCSDeMOStimNCT06110559
Use of tDCS Applied to the Orbitofrontal Cortex to Improve Risky Decision-making in a Clinical Population
A study testing Active transcranial direct current stimulation (tDCS) in people with Mood Disorders and Depression, run by Centre Hospitalier St Anne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mood Disorders, Depression, Suicide
- What is being tested?
- Active transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteFrance
- Study dates
- 16 Apr 2021to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Fabrice JOLLANT, MD PhD contact
France1 site, 1 recruiting
- Recruiting
GHU Paris Psychiatrie et Neurosciences - Hôpital Sainte-Anne - CMME
Paris, 75014
Michel DANON, MD, +33625201929, m.danon@ghu-paris.fr
Philip GORWOOD, MD PhD, p.gorwood@ghu-paris.fr
About this study
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
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.
Read the 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.
- Conditions
- Mood Disorders, Depression, Suicide
- Being tested
- Active transcranial direct current stimulation (tDCS), Sham transcranial direct current stimulation (tDCS)
- Keywords
- Endophenotype, Transcranial Direct Current Stimulation, Cognition
- Medical subject headings
- Mood Disorders, Depression, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| tDCS active comparator | Experimental | Active transcranial Direct Current Stimulation (tDCS): Stimulation of 1.5 mA for 30 minutes. Receives: 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. Receives: Device: Sham transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: Day 1 (end of study)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start16 Apr 2021
- Primary completion15 May 2024 (estimated)
- Study completion15 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel DANON, MD, Principal investigator, GHU Paris Pyschiatrie & Neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110559
- Sponsor's protocol ID
- D20-P041
- Acronym
- tDCSDeMOStim
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06110559
- Acronym / sponsor ID
- tDCSDeMOStim / D20-P041
- Conditions
- Mood Disorders, Depression, Suicide
- Keywords
- Endophenotype, Transcranial Direct Current Stimulation, Cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| tDCS active comparator | Experimental | Device: Active transcranial direct current stimulation (tDCS)Active transcranial Direct Current Stimulation (tDCS): Stimulation of 1.5 mA for 30 minutes. |
| tDCS sham comparator | Sham comparator | Device: Sham transcranial direct current stimulation (tDCS)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | tDCS active comparator |
| 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. | Device | tDCS sham comparator |
Primary outcome
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.
5 secondary outcomes
To assess whether the change in decision-making under tDCS stimulation is independent of emotional changes (sadness).
Time frame: 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)
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)
To assess whether tDCS stimulation of the OFC improves reduces susceptibility to interference compared to placebo stimulation.
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
Related trials for Mood Disorders
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Recruiting
MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
Schizophrenia Spectrum Disorders, Psychotic Affective Disorders
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
Active, not recruiting
AI Mental Health Tool vs. Psychoeducation Control
Depressive Disorder, Depressive Symptoms
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice JOLLANT, MD PhD contact
Michel DANON, MD principal investigator
GHU Paris Pyschiatrie & Neurosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active transcranial direct current stimulation (tDCS) in people with Mood Disorders and Depression, run by Centre Hospitalier St Anne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel DANON, MD (+33625201929, m.danon@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Day 1 (end of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.