Exploring the Role of the Prefrontal Cortex in Decision-Making

NCT ID: NCT07080489

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

444 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-04

Study Completion Date

2027-10-31

Brief Summary

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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

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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.

Conditions

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Depressive Disorder, Major Depressive Disorder Healthy Volunteer Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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Active Stimulation (Healthy)

Healthy adults aged 20 to 40 or 60 to 75 years.

Group Type EXPERIMENTAL

Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/F4

Intervention Type DEVICE

Participants receive anodal HD-tDCS targeting the left or right DLPFC (F3/F4).

Sham Stimulation (Healthy)

Healthy adults aged 20 to 40 or 60 to 75 years.

Group Type SHAM_COMPARATOR

Sham high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/F4

Intervention Type DEVICE

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 Stimulation (Patient)

Patients with mild to moderate depression aged 20 to 40 or 60 to 75 years.

Group Type EXPERIMENTAL

Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/ kathodal F4

Intervention Type DEVICE

Participants receive anodal HD-tDCS targeting the left DLPFC (F3) and cathodal stimulation targeting the right DLPFC (F4).

Sham Stimulation (Patient)

Patients with mild to moderate depression aged 20 to 40 or 60 to 75 years.

Group Type SHAM_COMPARATOR

Sham high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/ kathodal F4

Intervention Type DEVICE

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.

Interventions

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Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/F4

Participants receive anodal HD-tDCS targeting the left or right DLPFC (F3/F4).

Intervention Type DEVICE

Sham high-definition transcranial direct current stimulation (HD-tDCS) - anodal 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.

Intervention Type DEVICE

Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/ kathodal F4

Participants receive anodal HD-tDCS targeting the left DLPFC (F3) and cathodal stimulation targeting the right DLPFC (F4).

Intervention Type DEVICE

Sham high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/ kathodal 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

Exclusion Criteria

* 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
* psychiatric disorders other than depression (e.g., psychosis, mania, personality disorders) or depression with organic cause
* Presence of magnetizable implants
* Alcohol or drug dependence
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ki:elements

UNKNOWN

Sponsor Role collaborator

University of Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessica Peter, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Locations

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University of Bern, Department of Old Age Psychiatry and Psychotherapy

Bern, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Maya D Yilmaz, M.Sc.

Role: CONTACT

+41 58 630 79 62

Facility Contacts

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Jessica Peter, PhD

Role: primary

+41 58 630 89 03

Other Identifiers

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2024-01010

Identifier Type: -

Identifier Source: org_study_id

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