An interventional study of Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/F4 and Sham high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/F4 in Depressive Disorder, Major Depressive Disorder, Healthy Volunteer and Aging, sponsored by University of Bern. Recruiting at 1 site in Switzerland. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by University of Bern · Not applicable, Interventional, and Basic science
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
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.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's planned enrollment of 444 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →University of Bern is the lead sponsor of 209 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (Healthy):
Exclusion Criteria (Healthy):
Inclusion Criteria (Patient):
Exclusion Criteria (Patient):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy adults aged 20 to 40 or 60 to 75 years.
Device: Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/F4
Healthy adults aged 20 to 40 or 60 to 75 years.
Device: Sham high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/F4
Patients with mild to moderate depression aged 20 to 40 or 60 to 75 years.
Device: Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/ kathodal F4
Patients with mild to moderate depression aged 20 to 40 or 60 to 75 years.
Device: Sham high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/ kathodal F4
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.
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.
Time frame: 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.
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
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.
Time frame: 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.
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
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.
Time frame: During study visit; within 1 minute after the 20-minute stimulation period, during a 9-minute MRS scan
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During study visit; after stimulation, up to 1 hour
Verbal intelligence measured by Wortschatztest (WST)
The Wortschatztest (WST) is a standardized test assessing verbal intelligence by measuring vocabulary knowledge in German. It is administered to account for participants' baseline language ability, helping to control for individual differences in German word knowledge that may affect performance in the decision-making task. The maximum possible score is 42, with higher scores indicating better vocabulary knowledge.
Time frame: During study visit; at baseline, up to two hours before the 20-minute stimulation period
Number of (participants with) adverse effects
Participants report adverse effects using the Adverse Effects Questionnaire. They indicate the presence and severity of possible adverse effects related to transcranial direct current stimulation (tDCS), including headache, neck pain, scalp pain, tingling, itching, burning, drowsiness, and concentration difficulties. Severity is rated on a scale from none, mild, moderate, to strong. Participants also report the perceived duration of each sensation and whether they attribute it to the stimulation. Open responses for any additional sensations are collected.
Time frame: During study visit; after stimulation, up to 1 hour
Plan to share: Yes
Supporting information: Analytic code
Time frame: Data will be shared at the end of the study on a platform of the University of Bern (Boris Portal).
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Dec 2027, 33 months after the start.
Of 647 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 55. This study's planned 33 months is close to that.
Counting every sponsor, half of 687 studies reached it within 33 months; a quarter within 17 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
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