Behavior and Behavior MechanismsNCT05027854
Brain Network Mechanisms Causally Underlying Human Decisions Revealed by Brain Stimulation and Functional MRI
A study testing TMS or tES in people with Behavior and Behavior Mechanisms, run by Christian Ruff.
Trial summary
We will examine how stimulation of specific brain areas with transcranial magnetic stimulation (TMS) or transcranial electric stimulation (tES) changes specific aspects of behavior and brain activity, in order to test hypotheses about brain behavior relationships (basic research). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior and Behavior Mechanisms
- What is being tested?
- TMS or tES
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,800 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 30 Sep 2025
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- between 18 and 80 years of age (whereby for most studies the majority of recruited participants will be between 18 and 40 years of age)
- right-handedness and/or one specific gender (male or female) can be inclusion criteria to reduce variation in the data.
Who cannot join
- inability to understand the instructions and insufficient knowledge of the project language
- Internal electronic and/or metallic objects in the head, neck, or shoulders (e.g. artificial cochleae, deep brain stimulators, medical pumps, shrapnel, metallic splinters due to accidents during metal welding)
- One or more epileptic fits in the participant or a first-degree relative
- Vascular, traumatic, tumoral, infectious, or metabolic brain damage
- Use of medication that significantly alters cortical excitability
- Acute sleep deprivation or withdrawal from alcohol
- pregnancy
- to reduce bias, students of psychology or economics can be excluded if there is a possibility that they are familiar with the relevant paradigm.
Trial locations and contacts
No sites are listed yet.
About this study
We will examine how stimulation of specific brain areas with transcranial magnetic stimulation (TMS) or transcranial electric stimulation (tES) changes specific aspects of behavior and brain activity, in order to test hypotheses about brain behavior relationships (basic research).
- Conditions
- Behavior and Behavior Mechanisms
- Being tested
- TMS or tES, sham TMS or tES
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMS or tESOther
Transcranial magnetic or electric stimulation
sham TMS or tESOther
Sham transcranial magnetic or electric stimulation
| Study group | Role | What they receive |
|---|---|---|
| Stimulation | Experimental | TMS or tES, depending on experiment Receives: Other: TMS or tES |
| Sham | Sham comparator | Corresponding sham TMS or tES Receives: Other: sham TMS or tES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed of Behaviour
Reaction time in miliseconds
Measured: 0-60 minutes after stimulation
Accuracy of Behaviour
Accuracy in percent correct
Measured: 0-60 minutes after stimulation
Cognitive Function driving Behaviour
Parameter of Model describing cognitive function governing behaviour
Measured: 0-60 minutes after stimulation
Brain activity
BOLD contrast in fMRI data
Measured: 0-60 minutes after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior and Behavior MechanismsStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Ruff
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian Ruff, University of Zurich
- Investigators
- Christian Ruff, PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027854
- Sponsor's protocol ID
- 2020-01490
- Status last verified
- Aug 2021
- First submitted
- 16 Aug 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Network Mechanisms Causally Underlying Human Decisions Revealed by Brain Stimulation and Functional MRI
- ClinicalTrials.gov ID
- NCT05027854
- Acronym / sponsor ID
- 2020-01490
- Conditions
- Behavior and Behavior Mechanisms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Christian RuffUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 30 Aug 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.
We will examine how stimulation of specific brain areas with transcranial magnetic stimulation (TMS) or transcranial electric stimulation (tES) changes specific aspects of behavior and brain activity, in order to test hypotheses about brain behavior relationships (basic research).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulation | Experimental | Other: TMS or tESTMS or tES, depending on experiment |
| Sham | Sham comparator | Other: sham TMS or tESCorresponding sham TMS or tES |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- between 18 and 80 years of age (whereby for most studies the majority of recruited participants will be between 18 and 40 years of age)
- right-handedness and/or one specific gender (male or female) can be inclusion criteria to reduce variation in the data.
Key exclusion criteria (8 listed)
- inability to understand the instructions and insufficient knowledge of the project language
- Internal electronic and/or metallic objects in the head, neck, or shoulders (e.g. artificial cochleae, deep brain stimulators, medical pumps, shrapnel, metallic splinters due to accidents during metal welding)
- One or more epileptic fits in the participant or a first-degree relative
- Vascular, traumatic, tumoral, infectious, or metabolic brain damage
- Use of medication that significantly alters cortical excitability
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 |
|---|---|---|
| TMS or tESTranscranial magnetic or electric stimulation | Other | Stimulation |
| sham TMS or tESSham transcranial magnetic or electric stimulation | Other | Sham |
Primary outcome
Speed of Behaviour
Time frame: 0-60 minutes after stimulation
Reaction time in miliseconds
Accuracy of Behaviour
Time frame: 0-60 minutes after stimulation
Accuracy in percent correct
Cognitive Function driving Behaviour
Time frame: 0-60 minutes after stimulation
Parameter of Model describing cognitive function governing behaviour
Brain activity
Time frame: 0-60 minutes after stimulation
BOLD contrast in fMRI data
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Christian Ruff, PhD principal investigator
University of Zurich
Questions about this trial
What is this clinical trial studying?
A study testing TMS or tES in people with Behavior and Behavior Mechanisms, run by Christian Ruff.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Ruff, PhD (+41 44 634 50 67, christian.ruff@econ.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speed of Behaviour (time frame: 0-60 minutes after stimulation). The study lists 4 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 30 Aug 2021.