Reward-guided BehaviourNCT04761471
Oscillations in Reward-guided Behavior
A study testing TI transcranial electrical stimulation in people with Reward-guided Behaviour, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Reward-guided Behaviour
- What is being tested?
- TI transcranial electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2021to 4 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- pregnancy
- epilepsy
- head traumas
- implants (cochlear, neurostimulators, cardiac pacemakers, medication infusion device)
- metal in the brain or skull
- work in the metal industry
Show all 21Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Reward-guided Behaviour
- Being tested
- TI transcranial electrical stimulation
- Keywords
- Brain oscillations, Neural oscillations, Transcranial electrical stimulation tCS, Temporal Interference stimulation TI, Decision-making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TI transcranial electrical stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TI stimulation | Experimental | 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. Receives: Device: TI transcranial electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
Accuracy will be collected with a keyboard and a mouse
Measured: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
Reaction time
Reaction time will be collected with a keyboard and a mouse
Measured: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
Fixations
Fixations of the gaze on the screen will be recorded with an eye-tracker.
Measured: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
Saccades
Saccades (a type of the eye movement) will be recorded with an eye-tracker.
Measured: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
Blood oxygenation level dependent (BOLD)
BOLD signal is measured with functional magnetic resonance imaging (fMRI) experiment.
Measured: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
Brain oscillations in delta band
Oscillations within the range from 0.5 Hz to 4 Hz will be measured with electroencephalography (EEG).
Measured: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
Brain oscillations in theta band
Oscillations within the range from 4 Hz to 8 Hz will be measured with EEG.
Measured: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
Brain oscillations in alpha band
Oscillations within the range from 8 Hz to 12 Hz will be measured with EEG.
Measured: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
Brain oscillations in beta band
Oscillations within the range from 12 Hz to 30 Hz will be measured with EEG.
Measured: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
Brain oscillations in low gamma band
Oscillations within the range from 30 Hz to 70 Hz will be measured with EEG.
Measured: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
Brain oscillations in high gamma band
Oscillations within the range from 70 Hz to 250 Hz will be measured with EEG.
Measured: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Feb 2021
- Primary completion22 Nov 2022
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reward-guided BehaviourStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The same participants receive placebo/sham stimulation and active stimulation on different sessions separated with 1 week or within the same session. The sequence of sham/placebo and active stimulation will be randomized.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Polania, Swiss Federal Institute of Technology
- Investigators
- Rafael Polania, PhD, Principal investigator, ETH Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761471
- Sponsor's protocol ID
- TI_Reward
- Status last verified
- Dec 2023
- First submitted
- 5 Feb 2021
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Role of Brain Oscillations in Reward-guided Behavior
- ClinicalTrials.gov ID
- NCT04761471
- Acronym / sponsor ID
- TI_Reward
- Conditions
- Reward-guided Behaviour
- Keywords
- Brain oscillations, Neural oscillations, Transcranial electrical stimulation tCS, Temporal Interference stimulation TI, Decision-making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 21 Feb 2021 (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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The same participants receive placebo/sham stimulation and active stimulation on different sessions separated with 1 week or within the same session. The sequence of sham/placebo and active stimulation will be randomized.
| Arm | Type | Receives |
|---|---|---|
| TI stimulation | Experimental | Device: TI transcranial electrical stimulationTemporal 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- pregnancy
- epilepsy
- head traumas
- implants (cochlear, neurostimulators, cardiac pacemakers, medication infusion device)
- metal in the brain or skull
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 |
|---|---|---|
| TI transcranial electrical stimulationParticipants 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. | Device | TI stimulation |
Primary outcome
Accuracy
Time frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
Accuracy will be collected with a keyboard and a mouse
Reaction time
Time frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
Reaction time will be collected with a keyboard and a mouse
Fixations
Time frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
Fixations of the gaze on the screen will be recorded with an eye-tracker.
Saccades
Time frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
Saccades (a type of the eye movement) will be recorded with an eye-tracker.
Blood oxygenation level dependent (BOLD)
Time frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
BOLD signal is measured with functional magnetic resonance imaging (fMRI) experiment.
Brain oscillations in delta band
Time frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
Oscillations within the range from 0.5 Hz to 4 Hz will be measured with electroencephalography (EEG).
Brain oscillations in theta band
Time frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
Oscillations within the range from 4 Hz to 8 Hz will be measured with EEG.
Brain oscillations in alpha band
Time frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
Oscillations within the range from 8 Hz to 12 Hz will be measured with EEG.
Brain oscillations in beta band
Time frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
Oscillations within the range from 12 Hz to 30 Hz will be measured with EEG.
Brain oscillations in low gamma band
Time frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
Oscillations within the range from 30 Hz to 70 Hz will be measured with EEG.
Brain oscillations in high gamma band
Time frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.
Oscillations within the range from 70 Hz to 250 Hz will be measured with EEG.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Rafael Polania, PhD principal investigator
ETH Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TI transcranial electrical stimulation in people with Reward-guided Behaviour, run by Swiss Federal Institute of Technology 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 0 inclusion and 21 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: finished, as of the sponsor's last update on 13 Dec 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: Continuously while participants perform a cognitive task (circa 2 hours) with and without TI stimulation.). The study lists 11 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 13 Dec 2023.