HealthyNCT04263766

The Role of Different Prefrontal Areas in Visual Metacognition

A study testing Transcranial magnetic stimulation in people with Healthy, run by Georgia Institute of Technology at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Transcranial magnetic stimulation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 1 siteUnited States
Study dates: 22 Feb 2022to 31 Aug 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

right-handed
adults 18-40
with normal or corrected-to-normal vision

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for Advance Brain Imaging
Atlanta, Georgia, 30332

Other trials in United States

About this study

The study will use transcranial magnetic stimulation (TMS) to investigate the causal role of different brain regions during visual perception. TMS is a well-established technique used by hundreds of labs in the world. The risks associated with the technique are well understood and can be minimized by strict adherence to established safety guidelines. In the proposed study, the investigators will use TMS to specifically address the topic of how metacognitive evaluation is supported by the two prefrontal areas: the dorsolateral prefrontal cortex (DLPFC) and the anterior prefrontal cortex (aPFC). The data will be collected from healthy adults and will ultimately deepen the investigator's understanding of the mechanisms behind the normal processes related to confidence generation and metacognition.

Read the 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.

Conditions: Healthy
Being tested: Transcranial magnetic stimulation
Keywords: Transcranial Magnetic Stimulation, Metacognition, Prefrontal Cortex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial magnetic stimulationOther
TMS will be delivered to different brain areas in order to establish their contribution to visual metacognition.

Study groups in NCT04263766
Study group	Role	What they receive
Healthy Adult Volunteers	Experimental	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. Receives: Other: Transcranial magnetic stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Average Confidence Difference With the 0 ms Condition
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).
Measured: 6 months
Average Mratio Difference With the 0 ms Condition
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.
Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Feb 202231 Aug 2022

First posted11 Feb 2020
Study start22 Feb 2022
Primary completion31 Aug 2022
Study completion31 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies 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: TMS manipulation. Within-subjects design. Each participant will receive TMS to three different sites: DLPFC, aPFC, and a control site.
Masking: None (open label)
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04263766
Sponsor's protocol ID: H20033
Other IDs: 5R01MH119189
Status last verified: Aug 2023
First submitted: 7 Feb 2020
Last updated: 15 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Role of Different Prefrontal Areas in Visual Metacognition
ClinicalTrials.gov ID: NCT04263766
Acronym / sponsor ID: H20033
Conditions: Healthy
Keywords: Transcranial Magnetic Stimulation, Metacognition, Prefrontal Cortex
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Georgia Institute of TechnologyUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 22 Feb 2022 (actual)
Primary completion: 31 Aug 2022 (actual)
Study completion: 31 Aug 2022 (actual)
First posted: 11 Feb 2020 (actual)
Results: Posted 15 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: TMS manipulation. Within-subjects design. Each participant will receive TMS to three different sites: DLPFC, aPFC, and a control site.

Arm	Type	Receives
Healthy Adult Volunteers	Experimental	Other: Transcranial magnetic stimulationThe 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.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

right-handed
adults 18-40
with normal or corrected-to-normal vision

Key exclusion criteria (7 listed)

history of seizures
family history of epilepsy
stroke
severe headaches
metal anywhere in the head (excluding the mouth)

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
Transcranial magnetic stimulationTMS will be delivered to different brain areas in order to establish their contribution to visual metacognition.	Other	Healthy Adult Volunteers

Primary outcome

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).
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.

Results and safety

Results posted to the registry on 15 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DLPFC Group	50	43
Vertex Group	26	19

Primary outcome: Average Confidence Difference With the 0 ms Condition

Time frame: 6 months. Mean (Standard Deviation). Unit: score on a scale (1-4)

Measure	DLPFC-200 ms n = 31	DLPFC-300 ms n = 31	DLPFC-400 ms n = 31	DLPFC-500 ms n = 31	Vertex-200 ms n = 16	Vertex-300 ms n = 16	Vertex-400 ms n = 16	Vertex-500 ms n = 16
Value	0.14 (0.15)	0.14 (0.15)	0.14 (0.14)	0.15 (0.17)	-0.01 (0.05)	-0.04 (0.08)	-0.04 (0.10)	-0.04 (0.11)

DLPFC-200 ms vs DLPFC-300 ms vs DLPFC-400 ms vs DLPFC-500 ms vs Vertex-200 ms vs Vertex-300 ms vs Vertex-400 ms vs Vertex-500 ms: p <.001, t-test, 2 sided
DLPFC-200 ms vs DLPFC-300 ms vs DLPFC-400 ms vs DLPFC-500 ms vs Vertex-200 ms vs Vertex-300 ms: p = 0.99, ANOVA
Vertex-200 ms vs Vertex-300 ms vs Vertex-400 ms vs Vertex-500 ms: p = 0.83, ANOVA

Population analysed: The analysis population is after the exclusion of subjects who have their 0 ms condition accuracy 3.5% lower than the average accuracy of all delay conditions

Primary outcome: Average Mratio Difference With the 0 ms Condition

Time frame: 6 month. Mean (Standard Deviation). Unit: Ratio

Measure	DLPFC-200 ms n = 31	DLPFC-300 ms n = 31	DLPFC-400 ms n = 31	DLPFC-500 ms n = 31	Vertex-200 ms n = 16	Vertex-300 ms n = 16	Vertex-400 ms n = 16	Vertex-500 ms n = 16
Value	0.014 (0.959)	0.087 (0.429)	0.043 (0.586)	0.070 (0.467)	-0.211 (0.453)	-0.170 (0.436)	0.043 (0.386)	0.077 (0.432)

DLPFC-200 ms vs DLPFC-300 ms vs DLPFC-400 ms vs DLPFC-500 ms vs Vertex-200 ms vs Vertex-300 ms vs Vertex-400 ms vs Vertex-500 ms: p >0.19, ANOVA

Population analysed: The analysis population is after the exclusion of subjects whose 0 ms condition accuracy is 3.5% lower than the average accuracy of all four delay conditions.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DLPFC Group	0 of 50 (0%)	0 of 50 (0%)	0 of 50
Vertex Group	0 of 26 (0%)	0 of 26 (0%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Dobromir A. Rahnev, Ph.D. principal investigator

Georgia Institute of Technology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial magnetic stimulation in people with Healthy, run by Georgia Institute of Technology at 1 site in United States.

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 3 inclusion and 7 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 15 Sep 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 United States. 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?

Yes. Results are posted in the registry (first posted 15 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Average Confidence Difference With the 0 ms Condition (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04263766.

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 15 Sep 2023.