- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04263766
The Role of Different Prefrontal Areas in Visual Metacognition
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants will complete a task on visual perception and receive TMS in order to assess which regions of the brain are important for confidence generation in perceptual tasks. The task will involve judging the identity of visual stimuli (oriented black-and-white gratings) and providing a confidence rating on the judgment that they performed.
The researchers will deliver TMS to several brain regions such as the anterior prefrontal cortex (aPFC), dorsolateral prefrontal cortex (DLPFC), and a control site. The researchers will then investigate participants' accuracy and confidence levels depending on where TMS was delivered. The researchers expect that aPFC TMS will decrease the metacognitive sensitivity of the participants, whereas DLPFC TMS will decrease their average confidence level. TMS will be delivered time locked to the onset of the stimulus and the researchers will investigate what is the critical period of involvement of a given region.
The TMS protocol is well within the established safety limits. Participants will be required to fill out screening and demographic forms delivered at the Center for Advanced Brain Imaging (CABI). In order to dose appropriately the TMS stimulation, it is necessary to perform motor threshold determination. Motor threshold (MT) is defined as the minimum magnetic flux needed to elicit a visual hand twitch (in the contralateral first dorsal interosseus muscle). MT is the standard in the field for determining the intensity of TMS for each individual to reduce seizure risk. The scalp region producing the largest hand twitch will be identified. At that scalp location, the lowest TMS intensity able to elicit 5 visible twitches in 10 trials at this site will be determined. Individual MT will be used to determine the intensity of stimulation for each individual, as recommended by safety guidelines. This procedure usually takes about 5 minutes and also serves the purpose of acquainting participants to TMS stimulation. In this study, the researchers will use intensities between 100 and 120% of MT, even though the safety guidelines allow for stimulation intensities of at least 130% of MT.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30332
- Center for Advance Brain Imaging
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- right-handed
- adults 18-40
- with normal or corrected-to-normal vision
Exclusion Criteria:
- history of seizures
- family history of epilepsy
- stroke
- severe headaches
- metal anywhere in the head (excluding the mouth)
- cardiac pacemakers
- current use of medication for neurological or psychiatric conditions
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 |
---|---|
Experimental: Healthy Adult Volunteers
The experiment has a within-subject design where each subject will receive TMS to different brain areas.
The analysis will involve comparing the effects of TMS to different regions.
|
TMS will be delivered to different brain areas in order to establish their contribution to visual metacognition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Confidence Difference With the 0 ms Condition
Time Frame: 6 months
|
The average confidence difference for each delay condition and the 0 ms condition for each group (DLPFC or vertex).
Confidence was self-reported together with the decision on a 4-point scale with the minimum score being one (not confident at all) and the highest score being four (very confident).
The range of the scale is 1 (not confident at all) to 4 (very confident).
|
6 months
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Average Mratio Difference With the 0 ms Condition
Time Frame: 6 month
|
The average Mratio difference for each delay condition and the 0 ms condition for each group (DLPFC or vertex).
The Mratio is derived from signal detection theoretical modeling of the observer's decision and confidence response.
It is the ratio of two measures: the observer's metacognitive sensitivity (meta-d', the ability to discriminate between correct and incorrect responses) and the observer's stimulus sensitivity (d', the ability to discriminate between the two stimulus classes).
The Mratio could be calculated from subjects' self-rated confidence together with task performance.
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6 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dobromir A. Rahnev, Ph.D., Georgia Institute of Technology
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H20033
- 5R01MH119189 (U.S. NIH Grant/Contract)
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
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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