- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04761471
Oscillations in Reward-guided Behavior
Investigating the Role of Brain Oscillations in Reward-guided Behavior
While people are reading, talking or playing computer games, their brain cells elicit electrical signals so they could perform these actions. The firing of these cells is not random but is organized in a temporal pattern, such that a group of cells are simultaneously active at a particular frequency. The researchers can read the frequency of brain signals and identify their location using different brain-imaging tools like EEG and fMRI. These methods are applied to healthy individuals and do not pose any danger.
The investigators of this project would like to use these techniques to study the brain signals, while healthy participants are making the decisions choosing between 2 rewards, e.g., 2 food items. Participants who have depression show different behavior while performing decision-making tasks and the investigation of processes that underlie them will lead to a better understanding of this disease.
Furthermore, there is another category of tools, which help to study the brain. This category includes electrical stimulation, which mimics the electrical pattern that brain cells elicit. Application of external electrical stimulation can enhance this pattern or disrupt it and this process will affect the behavior of a person. Recent investigations have led to the development of a new stimulation technique that allows targeting deep brain regions. The investigators of this project want to apply this method to change the performance of healthy participants in the tasks on decision-making. If this experiment is successful, then stimulation can be used as a therapy for participants with depression.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Schweiz
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Zurich, Schweiz, Switzerland, 8057
- ETH Zurich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
General Inclusion Criteria:
- signed informed consent
- Age 18-40 years
- Normal physical and mental status (i.e. no neurological, musculoskeletal, neuromuscular, cognitive, or psychiatric disorders)
- If a participant already took part in the experiment with the same decision-making task
Exclusion Criteria for TI electrical stimulation:
- pregnancy
- epilepsy
- head traumas
- implants (cochlear, neurostimulators, cardiac pacemakers, medication infusion device)
- metal in the brain or skull
- work in the metal industry
- scars or inflammations on the regions, where the stimulation electrodes are placed
- administration of antipsychotic or anti-epileptic medication
- hearing problems or ringing in the ears
- syncope or fainting spells in the last 5 years
- severe side-effects after transcranial magnetic stimulation (TMS) or electrical stimulation if participant underwent it before
- the inability to comply with magnetic resonance imaging (MRI) inclusion criteria if participant underwent it before
Exclusion Criteria for MRI experiments:
- pregnancy
- claustrophobia
- history of brain surgery
- family member that suffers from epilepsy
- suffering from medication abuse for more than a year or drug intake
- taking medications for medical reasons for more than a month
- receiving of depot injections
- one or more of the following materials in the body: metallic objects (e.g., dental implants, a metallic splinter in the eye, but not braces); wire, pacemaker or implanted defibrillator; artificial heart valves; vascular grafts; bio-stimulator or nerve stimulator; aneurysm or intracranial clip; cochlear implant; other prostheses or orthoses; implanted medication pump (insulin or pain pump); medicated patch (e.g., nitro-patch, pain patch, nicotine patch, hormone patch, motion sickness patch); other implants; tattoo or jewelry
- history of any of these illnesses: brain thrombosis, stroke, traumatic brain injury, meningitis, heart attack, prolonged loss of consciousness, migraine, epilepsy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: TI stimulation
Temporal interference (TI) stimulation is a type of low-intensity transcranial electrical stimulation with alternating current (tACS).
In case of TI stimulation, 2 electric fields in kHz range are delivered to 4 electrodes, which are placed on the surface of the skull, to modulate neural oscillations.
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Participants will undergo transcranial electrical stimulation, which will be delivered with low current amplitudes (<= 2 mA) established with international safety guidelines for electrical stimulation. Threshold for the current amplitude will be established by participants themselves, such that they cannot distinguish when stimulation is applied and not applied. Duration of stimulation will not last longer than 30 minutes. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Accuracy
Time Frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
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Accuracy will be collected with a keyboard and a mouse
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Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
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Reaction time
Time Frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
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Reaction time will be collected with a keyboard and a mouse
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Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
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Fixations
Time Frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
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Fixations of the gaze on the screen will be recorded with an eye-tracker.
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Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
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Saccades
Time Frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
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Saccades (a type of the eye movement) will be recorded with an eye-tracker.
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Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
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Blood oxygenation level dependent (BOLD)
Time Frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
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BOLD signal is measured with functional magnetic resonance imaging (fMRI) experiment.
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Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
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Brain oscillations in delta band
Time Frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
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Oscillations within the range from 0.5 Hz to 4 Hz will be measured with electroencephalography (EEG).
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Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
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Brain oscillations in theta band
Time Frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
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Oscillations within the range from 4 Hz to 8 Hz will be measured with EEG.
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Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
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Brain oscillations in alpha band
Time Frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
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Oscillations within the range from 8 Hz to 12 Hz will be measured with EEG.
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Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
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Brain oscillations in beta band
Time Frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
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Oscillations within the range from 12 Hz to 30 Hz will be measured with EEG.
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Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
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Brain oscillations in low gamma band
Time Frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
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Oscillations within the range from 30 Hz to 70 Hz will be measured with EEG.
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Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
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Brain oscillations in high gamma band
Time Frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
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Oscillations within the range from 70 Hz to 250 Hz will be measured with EEG.
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Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Safety outcome (Headache)
Time Frame: This outcome will be recorded after each experiment with TI stimulation. One experiment lasts around 2 hours. These experiments will be held with different participants throughout the whole study (around 3 years).
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Headache severity will be collected with a questionnaire that contains a scale on which participant can rate this side-effect: (1) absent, (2) mild, (3) moderate, (4) severe.
After this question, participant is asked to estimate relationship of this side-effect to intervention: (1) none, (2) remote, (3) possible, (4) probable, (5) definite.
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This outcome will be recorded after each experiment with TI stimulation. One experiment lasts around 2 hours. These experiments will be held with different participants throughout the whole study (around 3 years).
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Safety outcome (Scalp pain)
Time Frame: This outcome will be recorded after each experiment with TI stimulation. One experiment lasts around 2 hours. These experiments will be held with different participants throughout the whole study (around 3 years).
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Scalp pain severity will be collected with a questionnaire that contains a scale on which participant can rate this side-effect: (1) absent, (2) mild, (3) moderate, (4) severe.
After this question, participant is asked to estimate relationship of this side-effect to intervention: (1) none, (2) remote, (3) possible, (4) probable, (5) definite.
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This outcome will be recorded after each experiment with TI stimulation. One experiment lasts around 2 hours. These experiments will be held with different participants throughout the whole study (around 3 years).
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Safety outcome (Tingling)
Time Frame: This outcome will be recorded after each experiment with TI stimulation. One experiment lasts around 2 hours. These experiments will be held with different participants throughout the whole study (around 3 years).
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Tingling severity will be collected with a questionnaire that contains a scale on which participant can rate this side-effect: (1) absent, (2) mild, (3) moderate, (4) severe.
After this question, participant is asked to estimate relationship of this side-effect to intervention: (1) none, (2) remote, (3) possible, (4) probable, (5) definite.
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This outcome will be recorded after each experiment with TI stimulation. One experiment lasts around 2 hours. These experiments will be held with different participants throughout the whole study (around 3 years).
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Safety outcome (Itching)
Time Frame: This outcome will be recorded after each experiment with TI stimulation. One experiment lasts around 2 hours. These experiments will be held with different participants throughout the whole study (around 3 years).
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Itching severity will be collected with a questionnaire that contains a scale on which participant can rate this side-effect: (1) absent, (2) mild, (3) moderate, (4) severe.
After this question, participant is asked to estimate relationship of this side-effect to intervention: (1) none, (2) remote, (3) possible, (4) probable, (5) definite.
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This outcome will be recorded after each experiment with TI stimulation. One experiment lasts around 2 hours. These experiments will be held with different participants throughout the whole study (around 3 years).
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Safety outcome (Burning)
Time Frame: This outcome will be recorded after each experiment with TI stimulation. One experiment lasts around 2 hours. These experiments will be held with different participants throughout the whole study (around 3 years).
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Burning sensations will be collected with a questionnaire that contains a scale on which participant can rate this side-effect: (1) absent, (2) mild, (3) moderate, (4) severe.
After this question, participant is asked to estimate relationship of this side-effect to intervention: (1) none, (2) remote, (3) possible, (4) probable, (5) definite.
|
This outcome will be recorded after each experiment with TI stimulation. One experiment lasts around 2 hours. These experiments will be held with different participants throughout the whole study (around 3 years).
|
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Safety outcome (Discomfort)
Time Frame: This outcome will be recorded after each experiment with TI stimulation. One experiment lasts around 2 hours. These experiments will be held with different participants throughout the whole study (around 3 years).
|
Discomfort sensations will be collected with a questionnaire that contains a scale on which participant can rate this side-effect: (1) absent, (2) mild, (3) moderate, (4) severe.
After this question, participant is asked to estimate relationship of this side-effect to intervention: (1) none, (2) remote, (3) possible, (4) probable, (5) definite.
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This outcome will be recorded after each experiment with TI stimulation. One experiment lasts around 2 hours. These experiments will be held with different participants throughout the whole study (around 3 years).
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Safety outcome (Nausea)
Time Frame: This outcome will be recorded after each experiment with TI stimulation. One experiment lasts around 2 hours. These experiments will be held with different participants throughout the whole study (around 3 years).
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Nausea sensations will be collected with a questionnaire that contains a scale on which participant can rate this side-effect: (1) absent, (2) mild, (3) moderate, (4) severe.
After this question, participant is asked to estimate relationship of this side-effect to intervention: (1) none, (2) remote, (3) possible, (4) probable, (5) definite.
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This outcome will be recorded after each experiment with TI stimulation. One experiment lasts around 2 hours. These experiments will be held with different participants throughout the whole study (around 3 years).
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Safety outcome (Fatigue)
Time Frame: This outcome will be recorded after each experiment with TI stimulation. One experiment lasts around 2 hours. These experiments will be held with different participants throughout the whole study (around 3 years).
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Fatigue sensations will be collected with a questionnaire that contains a scale on which participant can rate this side-effect: (1) absent, (2) mild, (3) moderate, (4) severe.
After this question, participant is asked to estimate relationship of this side-effect to intervention: (1) none, (2) remote, (3) possible, (4) probable, (5) definite.
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This outcome will be recorded after each experiment with TI stimulation. One experiment lasts around 2 hours. These experiments will be held with different participants throughout the whole study (around 3 years).
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Safety outcome (Acute mood change)
Time Frame: This outcome will be recorded after each experiment with TI stimulation. One experiment lasts around 2 hours. These experiments will be held with different participants throughout the whole study (around 3 years).
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Acute mood change will be collected with a questionnaire that contains a scale on which participant can rate this side-effect: (1) absent, (2) mild, (3) moderate, (4) severe.
After this question, participant is asked to estimate relationship of this side-effect to intervention: (1) none, (2) remote, (3) possible, (4) probable, (5) definite.
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This outcome will be recorded after each experiment with TI stimulation. One experiment lasts around 2 hours. These experiments will be held with different participants throughout the whole study (around 3 years).
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Safety outcome (Phosphenes)
Time Frame: This outcome will be recorded after each experiment with TI stimulation. One experiment lasts around 2 hours. These experiments will be held with different participants throughout the whole study (around 3 years).
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Phosphenes/light sensations will be collected with a questionnaire that contains a scale on which participant can rate this side-effect: (1) absent, (2) mild, (3) moderate, (4) severe.
After this question, participant is asked to estimate relationship of this side-effect to intervention: (1) none, (2) remote, (3) possible, (4) probable, (5) definite.
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This outcome will be recorded after each experiment with TI stimulation. One experiment lasts around 2 hours. These experiments will be held with different participants throughout the whole study (around 3 years).
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Safety outcome (Sleeplessness)
Time Frame: This outcome will be recorded after each experiment with TI stimulation. One experiment lasts around 2 hours. These experiments will be held with different participants throughout the whole study (around 3 years).
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Sleeplessness will be collected with a questionnaire that contains a scale on which participant can rate this side-effect: (1) absent, (2) mild, (3) moderate, (4) severe.
After this question, participant is asked to estimate relationship of this side-effect to intervention: (1) none, (2) remote, (3) possible, (4) probable, (5) definite.
|
This outcome will be recorded after each experiment with TI stimulation. One experiment lasts around 2 hours. These experiments will be held with different participants throughout the whole study (around 3 years).
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Collaborators and Investigators
Investigators
- Principal Investigator: Rafael Polania, PhD, ETH Zurich
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TI_Reward
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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