Exploring the Role of the Prefrontal Cortex in Decision-Making
1 other identifier
interventional
444
1 country
1
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 4, 2025
CompletedFirst Submitted
Initial submission to the registry
July 10, 2025
CompletedFirst Posted
Study publicly available on registry
July 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
July 23, 2025
July 1, 2025
2.3 years
July 10, 2025
July 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
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.
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.
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.
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.
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)
During study visit; at baseline, up to two hours before the 20-minute stimulation period
Negative Affect measured by PANAS (baseline)
During study visit; at baseline, up to two hours before the 20-minute stimulation period
Positive Affect measured by PANAS (after stimulation)
During study visit; after stimulation, up to 1 hour
Negative Affect measured by PANAS (after stimulation)
During study visit; after stimulation, up to 1 hour
Storytelling (baseline)
During study visit; at baseline, up to two hours before the 20-minute stimulation period
- +1 more secondary outcomes
Other Outcomes (2)
Verbal intelligence measured by Wortschatztest (WST)
During study visit; at baseline, up to two hours before the 20-minute stimulation period
Number of (participants with) adverse effects
During study visit; after stimulation, up to 1 hour
Study Arms (4)
Active Stimulation (Healthy)
EXPERIMENTALHealthy adults aged 20 to 40 or 60 to 75 years.
Sham Stimulation (Healthy)
SHAM COMPARATORHealthy adults aged 20 to 40 or 60 to 75 years.
Active Stimulation (Patient)
EXPERIMENTALPatients with mild to moderate depression aged 20 to 40 or 60 to 75 years.
Sham Stimulation (Patient)
SHAM COMPARATORPatients with mild to moderate depression aged 20 to 40 or 60 to 75 years.
Interventions
Participants receive anodal HD-tDCS targeting the left or right DLPFC (F3/F4).
Participants receive sham HD-tDCS targeting the left or right DLPFC (F3/F4). The device mimics the sensation of stimulation without delivering active current.
Participants receive anodal HD-tDCS targeting the left DLPFC (F3) and cathodal stimulation targeting the right DLPFC (F4).
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.
Eligibility Criteria
You may qualify if:
- 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
- Non-smoker
You may not qualify if:
- History of neurological disorders
- History of psychiatric disorders
- Use of psychotropic medication
- Presence of magnetizable implants
- Alcohol or drug dependence
- 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
- Intake of benzodiazepines or antipsychotic medication
- psychiatric disorders other than depression (e.g., psychosis, mania, personality disorders) or depression with organic cause
- Presence of magnetizable implants
- Alcohol or drug dependence
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Bernlead
- ki:elementscollaborator
Study Sites (1)
University of Bern, Department of Old Age Psychiatry and Psychotherapy
Bern, 3000, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica Peter, PhD
University of Bern
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Participants and experimentors are blinded to the intervention. The principal investigator managing randomization and code assignment is unblinded. Outcomes assessors remain blinded during data collection but will be unblinded after data collection is completed for final analysis.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2025
First Posted
July 23, 2025
Study Start
March 4, 2025
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
July 23, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ANALYTIC CODE
- Time Frame
- Data will be shared at the end of the study on a platform of the University of Bern (Boris Portal).