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StrokeNCT06920992

Cognitive Control Functions of the Human Thalamus

A study testing measuring cognitive flexibility including working memory and set-switching in people with Stroke, run by Kai Hwang 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

The goal of this research project is to investigate how brain lesions affect our ability to generate goal-directed behaviors - a cognitive function commonly referred to as cognitive control. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Stroke
What is being tested?
measuring cognitive flexibility including working memory and set-switching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
184 participants
Where
1 siteUnited States
Study dates
10 Mar 2020to 31 Dec 2025
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy adults age 18-35 without neurological or psychological disorders. No metal implants. No Claustrophobia.
  • Patients with focal lesions within the thalamus. Age 18 or older. No diagnosis of psychiatric disorders. No metal implants. No Claustrophobia.
  • Patients with focal lesions that spare the frontal and parietal cortices. Age 18 or older. No diagnosis of psychiatric disorders.
  • No metal implants. No Claustrophobia.

Who cannot join

  • claustrophobic Psychiatric conditions such as depression and ADHD. Implanted device such as cardia pacemakers and autodefbrillaotors, aneurysm, cochlear implants.
  • Not fluent in English.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The University of Iowa

    Iowa City, Iowa, 52246

Other trials in United States

About this study

Official title: Network Mechanisms of Cognitive Control

The goal of this research project is to investigate how brain lesions affect our ability to generate goal-directed behaviors - a cognitive function commonly referred to as cognitive control. To support goal-directed behaviors, the human brain must adaptively direct thoughts and actions depending on the current goals and contexts. Our principal hypothesis is that this cognitive capacity depends on a brain network architecture that can flexibly transmit, select, and inhibit information along neural pathways. Therefore, lesions and damages to critical brain network components will negatively affect behavior. To faithfully assess the structure and function of human brain networks and its disruption from brain lesions, investigators will recruit healthy adult human subjects and patients with brain lesions to participate in a multi-session study that includes cognitive behavioral tests, structural magnetic resonance imaging (MRI) using a 3 Tesla (3T) scanner, and electroencephalography (EEG) studies. During all testing sessions, subjects will perform cognitive tasks that assess their ability to select, maintain, and inhibit sensory information and generate motor responses. Their eye movements may be passively recorded during testings. 3T MRI allows for fast and high-resolution imaging of brain structures, enabling us to identify lesion loci. Investigators will use EEG to measure the electrophysiology of brain activities. All behavioral, EEG, and MRI data collected will be sent to the National Institute of Mental Health Data Archive (NDA) at the National Institute of Mental Health (NIMH).

Read the detailed description

There are 3 types of testing procedures, (cognitive behavioral testing, EEG, and MRI,) that investigators will describe in detail below. The types of procedures involved vary from participant to participant, depending on what kind of data investigators need and which procedure subjects agree to participate. The subject may participate in all testing procedures, (MRI, EEG, and behavioral,) two or three. The subject is also free to decline any of the testing procedures, equivalent to not participating in the research study. For each procedure, the testing time will never exceed 3 hours, so the maximum time commitment for the subject will be 9 hrs. For each subject, no more than two testing procedures will occur within 24 hours. When two testing procedures occur within the same 24-hour period, the time between the two testing procedures will be whatever is most convenient for the subject. The time between testing procedures that do not occur within the same 24-hour period will be whatever is most convenient for the subject, (this could mean weeks or months depending on the subject.) The specific procedure(s) the subject agrees to participate in will be checked on the consent form. The order which a subject will participate in these three types of procedures will also vary from subject to subject, which depends on the subject's schedule and the availability of the research facilities.

COGNITIVE BEHAVIORAL PROCEDURES: The type of cognitive task that will be administered aimed at measuring subject's ability to monitor internal goals and intentions, maintain and manipulate information in working memory, select task-relevant information, inhibit distractions, and organize action plans to accomplish these goals. These tasks involve the presentation of visual or auditory stimuli through a computer system, and the subjects must pay attention to the presented stimuli and make button press responses. Their eye movements may be monitored by a non-invasive eye-tracking device placed 1 to 2 feet in front of the participants. The eye-tracking device passively records the subject's eye gaze direction and no part of the device will be touching the subject, therefore, there will be no negative impact on the subject's comfort. The testing time for this procedure will be 1 to 3hrs.

EEG PROCEDURES: In this procedure, subjects will have EEG recorded while concurrently monitoring behavior. Subjects are asked to sit in a testing room and have conventional EEG electrodes placed on their scalp with conducting paste. The experiments involve the presentation of images on a computer monitor, sounds through speakers or headphones. The tasks may be changed flexibly as required by our behavioral testing of the tasks (i.e., is this task too easy for subjects? Too hard? These are questions investigators can only answer once investigators begin piloting the task behaviorally), however the task will always be asking subjects to manipulate the simple or complex stimuli in mind and respond to the participants in a brief period of time. The task will get at our questions about cognitive control by engaging brain regions involved in memorizing stimuli, attending to stimuli, ignoring stimuli, and preparing responses. These are components of cognitive control that are of interest for this project. The subject is asked to respond to certain stimuli by pressing a button. All stimuli are presented at a comfortable level. Similar to the cognitive behavioral procedure, a non-invasive eye tracking device may record subject's eye movements during EEG recording. This eye-tracking device is non-invasive and no parts of the device will cause any discomfort or interfere with the EEG recording. An EEG recording session typically takes 1 to 3hrs. The subject is given breaks every 5- 10 minutes, but may request a break or stop the experiment at any time. After the testing, investigators will remove the electrodes, and provide shampoo and towels for subjects to wash off the EEG conducting paste. Investigators will provide a hairdryer.

MRI (3T) PROCEDURES: Before participants enter the magnet room, participants will be screened for contradictions (i.e., metal implant). If the subject also wears glasses that contain metal to correct their visual acuity to 20/40 or better, investigators will have the subject use plastic, MR-compatible glasses provided by the MRI center. If the subject knows their prescription it will expedite the process of finding lenses suitable for the participants. If not, a few minutes will be allocated to trying on the best fitting pair to approximate the vision required to view the screen within the MRI, which is positioned close to subjects' face. Brain anatomical MRI scans are collected. Brain anatomical MRI scans are collected to determine the location of brain structures. In MRI studies, subjects who have history of brain MRIs will be acclimated to the MRI environment in a mock scanner. This is performed at a dedicated setup at MRRF in PBDB. For comfort, foam pads are placed around the subject's head to limit head movement during the scan. A MRI scanning session takes about 40 - 60 minutes and the subject is given breaks every 5-10 minutes. The subject may request a break or stop the experiment at any time.

Conditions
Stroke
Being tested
measuring cognitive flexibility including working memory and set-switching
Keywords
Cognitive Control, Stroke, Thalamus
Medical subject headings
Stroke

What participants receive

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

  • measuring cognitive flexibility including working memory and set-switchingBehavioural

    A behavioral task that requires subjects to switch between stimulus- response contingencies based on a colored contextual cue. In addition, this task requires subjects to memorize a set of visual stimuli. Subjects will then be presented with a test set and will be asked to indicate whether any stimulus therein is not part of original memorized set. Three conditions will be measured, including EDS (extradimensional shift), IDS (intradimensionaly shift), and Stay (no switching).

Study groups in NCT06920992
Study groupRoleWhat they receive
Determine how the thalamus contributes to cognitive controlExperimentalWe conducted cognitive behavioral testing on cognitive flexibility using EEG, fMRI and behavioral experiments. The intervention for all three methods (EEG, fMRI, behavioral) were the same, subjects performed a cognitive flexibility task with three conditions: extradimensional shift, intradimensional shift, and no switching condition. With all three experiments we can measure the behavioral accuracy. With fMRI we can measure evoked fMRI response amplitude in the thalamus, with EEG we can measure scalp voltage signal in patients.
Receives: Behavioral: measuring cognitive flexibility including working memory and set-switching

What is being measured

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

  1. Cognitive Flexibility Performance as Measured by Accuracy, in the Unit of Percentage of Correct Responses

    The accuracy measure of the behavioral task will determine whether the hypothesized cognitive function of cognitive flexibility is implemented by a hierarchical cognitive control model instantiated in the human thalamus. A lower accuracy scale for the extradimensional shift condition (EDS) relative to other conditions would suggest increased difficulty in engaging in cognitive flexibility. The scale is from 0 to 100.

    Measured: 2 weeks

  2. Measure of Thalamus Response to Cognitive Flexibility, in the Unit of fMRI BOLD Signal Increase Relative to no Stimulus Presentation.

    When subjects perform the cognitive flexibility task, we can then measure how strongly the medial thalamus responds to different task conditions. The signal scale will be in beta coefficients measured by fMRI BOLD response. This is a measurement of relative signal increase in response to the presented task. A higher beta value for the thalamus for the extradimensional shift condition would indicate thalamus involvement in cognitive flexibility. The scale is from -100 to 100

    Measured: 2 hours

Secondary outcomes (1)
  1. EEG Oscillations in the Theta Frequency Band, in the Unit of Signal Increase Relative to Recordings From no Stimulus Presentation.

    In stroke patients, we can measure their EEG response in the theta frequency band in response to the three cognitive flexibility conditions (EDS, IDS, Stay). The measure is percent signal change (%) from -100 to 100. We expect that there should be no difference in this measure, indicating that the brain structure is limiting patients' ability to engage in cognitive flexibility-related brain processes.

    Measured: 2hrs

Timeline

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

  1. First posted10 Apr 2025
  2. Study start10 Mar 2020
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

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
Compare patients with stroke with healthy comparisons
Masking
None (open label)
Enrolment
184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06920992
Sponsor's protocol ID
201808855
Other IDs
R01MH122613
Status last verified
Aug 2026
First submitted
26 Mar 2025
Last updated
15 Sep 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is a BESH study (https://grants.nih.gov/policy-and-compliance/policy-topics/clinical-trials/besh) and the investigators will not be publishing in ICMJE journals.

Publications

  • Shine JM, Lewis LD, Garrett DD, Hwang K. The impact of the human thalamus on brain-wide information processing. Nat Rev Neurosci. 2023 Jul;24(7):416-430. doi: 10.1038/s41583-023-00701-0. Epub 2023 May 26.

    PubMed 37237103
  • Cellier D, Petersen IT, Hwang K. Dynamics of Hierarchical Task Representations. J Neurosci. 2022 Sep 21;42(38):7276-7284. doi: 10.1523/JNEUROSCI.0233-22.2022.

    PubMed 35985836
  • Hwang K, Bruss J, Tranel D, Boes AD. Network Localization of Executive Function Deficits in Patients with Focal Thalamic Lesions. J Cogn Neurosci. 2020 Dec;32(12):2303-2319. doi: 10.1162/jocn_a_01628. Epub 2020 Sep 9.

    PubMed 32902335
  • Hwang K, Shine JM, Bruss J, Tranel D, Boes A. Neuropsychological evidence of multi-domain network hubs in the human thalamus. Elife. 2021 Oct 8;10:e69480. doi: 10.7554/eLife.69480.

    PubMed 34622776
  • Chen X, Leach SC, Hollis J, Cellier D, Hwang K. The thalamus encodes and updates context representations during hierarchical cognitive control. PLoS Biol. 2024 Dec 2;22(12):e3002937. doi: 10.1371/journal.pbio.3002937. eCollection 2024 Dec.

    PubMed 39621781

Questions about this trial

What is this clinical trial studying?

A study testing measuring cognitive flexibility including working memory and set-switching in people with Stroke, run by Kai Hwang 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 4 inclusion and 2 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 2026. 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 2026). 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?

Cognitive Flexibility Performance as Measured by Accuracy, in the Unit of Percentage of Correct Responses (time frame: 2 weeks). 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 NCT06920992, which also lists 5 linked publications.

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 2026.

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