Brain Network Mechanisms Causally Underlying Human Decisions Revealed by Brain Stimulation and Functional MRI

August 23, 2021 updated by: Christian Ruff
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 Overview

Status

Not yet recruiting

Study Type

Interventional

Enrollment (Anticipated)

1800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stimulation
TMS or tES, depending on experiment
Transcranial magnetic or electric stimulation
Sham Comparator: Sham
Corresponding sham TMS or tES
Sham transcranial magnetic or electric stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speed of Behaviour
Time Frame: 0-60 minutes after stimulation
Reaction time in miliseconds
0-60 minutes after stimulation
Accuracy of Behaviour
Time Frame: 0-60 minutes after stimulation
Accuracy in percent correct
0-60 minutes after stimulation
Cognitive Function driving Behaviour
Time Frame: 0-60 minutes after stimulation
Parameter of Model describing cognitive function governing behaviour
0-60 minutes after stimulation
Brain activity
Time Frame: 0-60 minutes after stimulation
BOLD contrast in fMRI data
0-60 minutes after stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Christian Ruff, PhD, University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

September 30, 2025

Study Completion (Anticipated)

September 30, 2025

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

August 23, 2021

First Posted (Actual)

August 30, 2021

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2020-01490

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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