NCT06920992

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2020

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

5.8 years

First QC Date

March 26, 2025

Last Update Submit

April 12, 2026

Conditions

Keywords

Cognitive ControlStrokeThalamus

Outcome Measures

Primary Outcomes (2)

  • Cognitive flexibility performance as measured by accuracy, in the unit of percent of accurate responses.

    Accuracy measure of the behavioral task will determine whether the hypothesized cognitive function of cognitive flexibility is impaired. Impairment will lead to below chance response.

    2 weeks

  • Cognitive flexibility function as measured by reaction time to cognitive switching manipulation, un the unit of seconds.

    The speed of cognitive switching can be measured by the reaction time to stimulus, in seconds.

    2 weeks

Study Arms (1)

Determine the effects of subcortical thalamic lesions

EXPERIMENTAL

There are 3 types of testing procedures, (cognitive behavioral testing, EEG, and MRI). 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.

Behavioral: Working memory and set-switching tasks

Interventions

A behavioral task that requires subjects to switch between stimulus- response contingencies based on a colored contextual cue. In addition, a behavioral task that 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.

Determine the effects of subcortical thalamic lesions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Iowa

Iowa City, Iowa, 52246, United States

Location

Related Publications (5)

  • 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.

    PMID: 37237103BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Compare patients with stroke with healthy comparisons
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 26, 2025

First Posted

April 10, 2025

Study Start

March 10, 2020

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations