Depressive Disorder, Major Depressive DisorderNCT07080489
Exploring the Role of the Prefrontal Cortex in Decision-Making
A study testing Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/F4 and Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/ kathodal F4 in people with Depressive Disorder, Major Depressive Disorder and Healthy Volunteer, run by University of Bern at 1 site in Switzerland.
Trial summary
The goal of this study is to examine whether high-definition transcranial direct current stimulation (HD-tDCS) can influence decision-making for emotionally valenced content in younger and older adults, with or without major depression. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Major Depressive Disorder, Healthy Volunteer, Aging
- What is being tested?
- Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/F4 and Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/ kathodal F4
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 444 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Mar 2025to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written Informed Consent
- Age between 20-40 or 60-75 years
- Fluent in German
- Normal or corrected-to-normal vision
- No color blindness
- Right-handed
Show all 13Show fewer
- Non-smoker
- Written Informed Consent
- Diagnosed with mild to moderate depression
- Age between 20-40 or 60-75 years
- Fluent in German
- Normal or corrected-to-normal vision
- No color blindness
Who cannot join
- History of neurological disorders
- History of psychiatric disorders
- Use of psychotropic medication
- Presence of magnetizable implants
- Alcohol or drug dependence
- Intake of benzodiazepines or antipsychotic medication
Show all 9Show fewer
- psychiatric disorders other than depression (e.g., psychosis, mania, personality disorders) or depression with organic cause
- Presence of magnetizable implants
- Alcohol or drug dependence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University of Bern, Department of Old Age Psychiatry and Psychotherapy
Bern, 3000
Jessica Peter, PhD, +41 58 630 89 03, jessica.peter@unibe.ch
About this study
The goal of this study is to examine whether high-definition transcranial direct current stimulation (HD-tDCS) can influence decision-making for emotionally valenced content in younger and older adults, with or without major depression.
The main questions are:
Read more
In healthy adults, does brain stimulation modulate how people respond to emotionally valenced content during a decision-making task? What happens in the brain during modulation? Do these effects differ between younger and older adults?
In adults with depression, does brain stimulation help shift attention towards positive content during the task? What happens in the brain? Are these effects moderated by age (younger vs. older adults)?
The investigators will compare participants who receive real stimulation to those who receive sham (placebo) stimulation.
Participants will:
Receive high-definition transcranial direct current stimulation (HD-tDCS) of the dorsolateral prefrontal cortex (DLPFC)
Perform a decision-making task involving emotionally valenced words
Complete the task while undergoing a brain scan using ultra-high field 7 Tesla magnetic resonance imaging (MRI) to measure brain activity
Read the detailed description
This study investigates whether non-invasive brain stimulation influences decision-making in four groups: younger adults (20-40 years) and older adults (60-75 years), healthy or with mild to moderate major depression. Participants with personality disorders or psychosis will be excluded.
The study builds on evidence that the dorsolateral prefrontal cortex (DLPFC) plays a key role in evaluating emotionally-valenced material and decision-making. The investigators will examine whether modulation of this region through high-definition transcranial direct current stimulation (HD-tDCS) affects responses to emotionally valenced information. Stimulation will be administered differently across groups based on theoretical models of hemispheric function in mood regulation.
To explore the effect of stimulation at neurotransmitter level, the investigators will use ultra-high field 7 Tesla magnetic resonance spectroscopy (MRS) to measure Gamma-aminobutyric acid (GABA) / Glutamate concentrations in regions of interest at baseline and after stimulation. This allows to examine whether changes in inhibitory/excitatory neurotransmitters are linked to altered emotional processing and decision making.
By combining brain stimulation, ultra-high field neuroimaging, and spectroscopy, this study examines how changes in brain network activity and neurotransmitter levels relate to decision-making in health and disease. The inclusion of both younger and older adults allows the investigators to explore age-related differences in these processes.
This project aims to provide mechanistic insights into decision-making in health and disease and to support the development of targeted neuromodulation therapies that could modulate emotional processing.
- Being tested
- Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/F4, Sham high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/F4, Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/ kathodal F4, Sham high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/ kathodal F4
- Keywords
- UHF fMRI, DLPFC, fMRI, HD-tDCS, Cognitive Control, Noninvasive Brain Stimulation, Depression, Aging
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/F4Device
Participants receive anodal HD-tDCS targeting the left or right DLPFC (F3/F4).
Sham high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/F4Device
Participants receive sham HD-tDCS targeting the left or right DLPFC (F3/F4). The device mimics the sensation of stimulation without delivering active current.
Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/ kathodal F4Device
Participants receive anodal HD-tDCS targeting the left DLPFC (F3) and cathodal stimulation targeting the right DLPFC (F4).
Sham high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/ kathodal F4Device
Participants receive sham HD-tDCS targeting the left DLPFC (F3) and right DLPFC (F4). The device mimics the sensation of stimulation without delivering active current.
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation (Healthy) | Experimental | Healthy adults aged 20 to 40 or 60 to 75 years. Receives: Device: Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/F4 |
| Sham Stimulation (Healthy) | Sham comparator | Healthy adults aged 20 to 40 or 60 to 75 years. Receives: Device: Sham high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/F4 |
| Active Stimulation (Patient) | Experimental | Patients with mild to moderate depression aged 20 to 40 or 60 to 75 years. Receives: Device: Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/ kathodal F4 |
| Sham Stimulation (Patient) | Sham comparator | Patients with mild to moderate depression aged 20 to 40 or 60 to 75 years. Receives: Device: Sham high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/ kathodal F4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood-oxygen-level-dependent (BOLD) signal changes during task-based functional magnetic resonance imaging (fMRI)
Blood-oxygen-level-dependent (BOLD) signal changes will be measured using ultra-high field functional magnetic resonance imaging (fMRI) during a cognitive decision-making task designed to engage prefrontal cortex regions associated with cognitive control and decision making. Structural T1-weighted and T2-weighted images will also be acquired for anatomical localization and normalization. Primary regions of interest (ROIs) include the dorsolateral prefrontal cortex (DLPFC), subgenual anterior cingulate cortex (sgACC), amygdala, and hippocampus.
Measured: During study visit; measured continuously during the 20-minute stimulation period
GABA concentration (baseline)
Magnetic resonance spectroscopy (MRS) will be used to measure Gamma-aminobutyric acid (GABA) concentrations in regions of interest at baseline. The goal is to examine stimulation-related neutransmitter changes.
Measured: During study visit; during a 9-minute magnetic resonance spectroscopy (MRS) session performed up to 10 minutes prior to the 20-minute stimulation period
GABA concentration (after stimulation)
Magnetic resonance spectroscopy (MRS) will be used to measure Gamma-aminobutyric acid (GABA) concentrations in regions of interest after HD-tDCS. The goal is to examine stimulation-related neutransmitter changes.
Measured: During study visit; within 1 minute after the 20-minute stimulation period, during a 9-minute MRS scan
Glutamate concentration (baseline)
Magnetic resonance spectroscopy (MRS) will be used to measure Glutamate concentrations in regions of interest at baseline. The goal is to examine stimulation-related neutransmitter changes.
Measured: During study visit; during a 9-minute magnetic resonance spectroscopy (MRS) session performed up to 10 minutes prior to the 20-minute stimulation period
Glutamate concentration (after stimulation)
Magnetic resonance spectroscopy (MRS) will be used to measure Glutamate concentrations in regions of interest after HD-tDCS. The goal is to examine stimulation-related neutransmitter changes.
Measured: During study visit; within 1 minute after the 20-minute stimulation period, during a 9-minute MRS scan
Secondary outcomes (6)
Positive Affect measured by PANAS (baseline)
Positive Affect will be assessed using the Positive Affect subscale of the Positive and Negative Affect Schedule (PANAS). This subscale includes 10 items reflecting positive emotions. Each item is rated on a 5-point Likert scale. The sum score ranges from 10 to 50, with higher scores indicating greater levels of positive affect.
Measured: During study visit; at baseline, up to two hours before the 20-minute stimulation period
Negative Affect measured by PANAS (baseline)
Negative Affect will be assessed using the Negative Affect subscale of the Positive and Negative Affect Schedule (PANAS). This subscale includes 10 items reflecting negative emotions. Each item is rated on a 5-point Likert scale. The sum score ranges from 10 to 50, with higher scores indicating greater levels of negative affect.
Measured: During study visit; at baseline, up to two hours before the 20-minute stimulation period
Positive Affect measured by PANAS (after stimulation)
Positive Affect will be assessed using the Positive Affect subscale of the Positive and Negative Affect Schedule (PANAS). This subscale includes 10 items reflecting positive emotions. Each item is rated on a 5-point Likert scale. The sum score ranges from 10 to 50, with higher scores indicating greater levels of positive affect.
Measured: During study visit; after stimulation, up to 1 hour
Negative Affect measured by PANAS (after stimulation)
Negative Affect will be assessed using the Negative Affect subscale of the Positive and Negative Affect Schedule (PANAS). This subscale includes 10 items reflecting negative emotions. Each item is rated on a 5-point Likert scale. The sum score ranges from 10 to 50, with higher scores indicating greater levels of negative affect.
Measured: During study visit; after stimulation, up to 1 hour
Storytelling (baseline)
Participants will be asked to verbally recall one positive and one negative autobiographical memory. Verbal responses will be audio recorded and analyzed using automated speech analysis. The analysis will be performed by ki:elements, an external provider specialized in speech analysis.
Measured: During study visit; at baseline, up to two hours before the 20-minute stimulation period
Storytelling (after stimulation)
Participants will be asked to verbally recall one positive and one negative autobiographical memory. Verbal responses will be audio recorded and analyzed using automated speech analysis. The analysis will be performed by ki:elements, an external provider specialized in speech analysis.
Measured: During study visit; after stimulation, up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start4 Mar 2025
- Primary completionDec 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of BernThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 444 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- ki:elements
- Responsible party
- Sponsor
- Investigators
- Jessica Peter, PhD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080489
- Sponsor's protocol ID
- 2024-01010
- Status last verified
- Aug 2026
- First submitted
- 10 Jul 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Role of the Prefrontal Cortex in Decision-Making
- ClinicalTrials.gov ID
- NCT07080489
- Acronym / sponsor ID
- 2024-01010
- Keywords
- UHF fMRI, DLPFC, fMRI, HD-tDCS, Cognitive Control, Noninvasive Brain Stimulation, Depression, Aging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 444 participants (estimated)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- ki:elements
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 23 Jul 2025 (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.
The goal of this study is to examine whether high-definition transcranial direct current stimulation (HD-tDCS) can influence decision-making for emotionally valenced content in younger and older adults, with or without major depression.
The main questions are:
In healthy adults, does brain stimulation modulate how people respond to emotionally valenced content during a decision-making task? What happens in the brain during modulation? Do these effects differ between younger and older adults?
In adults with depression, does brain stimulation help shift attention towards positive content during the task? What happens in the brain? Are these effects moderated by age (younger vs. older adults)?
The investigators will compare participants who receive real stimulation to those who receive sham (placebo) stimulation.
Participants will:
Receive high-definition transcranial direct current stimulation (HD-tDCS) of the dorsolateral prefrontal cortex (DLPFC)
Perform a decision-making task involving emotionally valenced words
Complete the task while undergoing a brain scan using ultra-high field 7 Tesla magnetic resonance imaging (MRI) to measure brain activity
Detailed description
This study investigates whether non-invasive brain stimulation influences decision-making in four groups: younger adults (20-40 years) and older adults (60-75 years), healthy or with mild to moderate major depression. Participants with personality disorders or psychosis will be excluded.
The study builds on evidence that the dorsolateral prefrontal cortex (DLPFC) plays a key role in evaluating emotionally-valenced material and decision-making. The investigators will examine whether modulation of this region through high-definition transcranial direct current stimulation (HD-tDCS) affects responses to emotionally valenced information. Stimulation will be administered differently across groups based on theoretical models of hemispheric function in mood regulation.
To explore the effect of stimulation at neurotransmitter level, the investigators will use ultra-high field 7 Tesla magnetic resonance spectroscopy (MRS) to measure Gamma-aminobutyric acid (GABA) / Glutamate concentrations in regions of interest at baseline and after stimulation. This allows to examine whether changes in inhibitory/excitatory neurotransmitters are linked to altered emotional processing and decision making.
By combining brain stimulation, ultra-high field neuroimaging, and spectroscopy, this study examines how changes in brain network activity and neurotransmitter levels relate to decision-making in health and disease. The inclusion of both younger and older adults allows the investigators to explore age-related differences in these processes.
This project aims to provide mechanistic insights into decision-making in health and disease and to support the development of targeted neuromodulation therapies that could modulate emotional processing.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation (Healthy) | Experimental | Device: Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/F4Healthy adults aged 20 to 40 or 60 to 75 years. |
| Sham Stimulation (Healthy) | Sham comparator | Device: Sham high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/F4Healthy adults aged 20 to 40 or 60 to 75 years. |
| Active Stimulation (Patient) | Experimental | Device: Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/ kathodal F4Patients with mild to moderate depression aged 20 to 40 or 60 to 75 years. |
| Sham Stimulation (Patient) | Sham comparator | Device: Sham high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/ kathodal F4Patients with mild to moderate depression aged 20 to 40 or 60 to 75 years. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written Informed Consent
- Age between 20-40 or 60-75 years
- Fluent in German
- Normal or corrected-to-normal vision
- No color blindness
Key exclusion criteria (9 listed)
- History of neurological disorders
- History of psychiatric disorders
- Use of psychotropic medication
- Presence of magnetizable implants
- Alcohol or drug dependence
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 high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/F4Participants receive anodal HD-tDCS targeting the left or right DLPFC (F3/F4). | Device | Active Stimulation (Healthy) |
| Sham high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/F4Participants receive sham HD-tDCS targeting the left or right DLPFC (F3/F4). The device mimics the sensation of stimulation without delivering active current. | Device | Sham Stimulation (Healthy) |
| Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/ kathodal F4Participants receive anodal HD-tDCS targeting the left DLPFC (F3) and cathodal stimulation targeting the right DLPFC (F4). | Device | Active Stimulation (Patient) |
| Sham high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/ kathodal F4Participants receive sham HD-tDCS targeting the left DLPFC (F3) and right DLPFC (F4). The device mimics the sensation of stimulation without delivering active current. | Device | Sham Stimulation (Patient) |
Primary outcome
Blood-oxygen-level-dependent (BOLD) signal changes during task-based functional magnetic resonance imaging (fMRI)
Time frame: During study visit; measured continuously during the 20-minute stimulation period
Blood-oxygen-level-dependent (BOLD) signal changes will be measured using ultra-high field functional magnetic resonance imaging (fMRI) during a cognitive decision-making task designed to engage prefrontal cortex regions associated with cognitive control and decision making. Structural T1-weighted and T2-weighted images will also be acquired for anatomical localization and normalization. Primary regions of interest (ROIs) include the dorsolateral prefrontal cortex (DLPFC), subgenual anterior cingulate cortex (sgACC), amygdala, and hippocampus.
GABA concentration (baseline)
Time frame: During study visit; during a 9-minute magnetic resonance spectroscopy (MRS) session performed up to 10 minutes prior to the 20-minute stimulation period
Magnetic resonance spectroscopy (MRS) will be used to measure Gamma-aminobutyric acid (GABA) concentrations in regions of interest at baseline. The goal is to examine stimulation-related neutransmitter changes.
GABA concentration (after stimulation)
Time frame: During study visit; within 1 minute after the 20-minute stimulation period, during a 9-minute MRS scan
Magnetic resonance spectroscopy (MRS) will be used to measure Gamma-aminobutyric acid (GABA) concentrations in regions of interest after HD-tDCS. The goal is to examine stimulation-related neutransmitter changes.
Glutamate concentration (baseline)
Time frame: During study visit; during a 9-minute magnetic resonance spectroscopy (MRS) session performed up to 10 minutes prior to the 20-minute stimulation period
Magnetic resonance spectroscopy (MRS) will be used to measure Glutamate concentrations in regions of interest at baseline. The goal is to examine stimulation-related neutransmitter changes.
Glutamate concentration (after stimulation)
Time frame: During study visit; within 1 minute after the 20-minute stimulation period, during a 9-minute MRS scan
Magnetic resonance spectroscopy (MRS) will be used to measure Glutamate concentrations in regions of interest after HD-tDCS. The goal is to examine stimulation-related neutransmitter changes.
6 secondary outcomes
Positive Affect measured by PANAS (baseline)
Time frame: During study visit; at baseline, up to two hours before the 20-minute stimulation period
Negative Affect measured by PANAS (baseline)
Time frame: During study visit; at baseline, up to two hours before the 20-minute stimulation period
Positive Affect measured by PANAS (after stimulation)
Time frame: During study visit; after stimulation, up to 1 hour
Negative Affect measured by PANAS (after stimulation)
Time frame: During study visit; after stimulation, up to 1 hour
Storytelling (baseline)
Time frame: During study visit; at baseline, up to two hours before the 20-minute stimulation period
Storytelling (after stimulation)
Time frame: During study visit; after stimulation, up to 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Yes
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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.
Jessica Peter, PhD principal investigator
University of Bern
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 high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/F4 and Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/ kathodal F4 in people with Depressive Disorder, Major Depressive Disorder and Healthy Volunteer, run by University of Bern at 1 site in Switzerland.
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 13 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 31 Aug 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maya D Yilmaz, M.Sc. (+41 58 630 79 62, maya.yilmaz@unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood-oxygen-level-dependent (BOLD) signal changes during task-based functional magnetic resonance imaging (fMRI) (time frame: During study visit; measured continuously during the 20-minute stimulation period). The study lists 5 primary outcomes in all. 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 31 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.