Exploring the Relationship Between Brain Asymmetry and Attention

Background:

People tend to pay more attention to one side of space than the other and this may be due to differences in the structure and function of the two sides of the brain. We are interested in whether we can detect those difference with magnetic resonance imaging (MRI), transcranial magnetic stimulation (TMS), and electroencephalography (EEG).

Objective:

The purpose of the study is to understand how differences in brain structure may cause people to pay more attention to one side than the other.

Eligibility:

Healthy adults ages 18-35

Design:

Participants will be screened with a neurological exam.

Participants will have 2-3 visits for a total duration of about 7/8 hours.

Women of childbearing age must have a negative pregnancy test before each MRI scan.

Visits may include:

Physical exam

Tests of attention, and thinking

TMS. A brief electrical current will pass through a wire coil on the scalp. Participants will hear a click and may feel a pull. They may be asked to tense muscles or do tasks.

Magnetic resonance imaging (MRI) scan for a maximum of 1 hour. Participants will lie on a table that slides into a cylinder in a strong magnetic field. They will do tasks on a computer screen or lie still. They will get earplugs for loud noise.

EEG for no longer than 5 hours, with most lasting 3 hours. Gel and a cap with electrodes will be placed on the scalp. They will record brain waves while the participant gets TMS or does nothing.

Questions about participants dominant hand and about the MRI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective

The goal of this protocol to explore correlations between lateralized individual differences in visual attentional preference and hemispheric asymmetries in functional connectivity between the frontal and parietal visual attention areas. To measure functional connectivity, resting state functional MRI and electroencephalographic (EEG) potentials evoked with transcranial magnetic stimulation (TMS) will be used. Protocol research will also attempt to validate the TMS-evoked EEG potentials against fMRI resting state functional connectivity.

Study Population

Up to 80 right-handed and right-eyed healthy volunteers, aged 18-35

Design

TMS evoked EEG potentials (TEPs) and fMRI will be used to measure functional connectivity between the posterior parietal cortex and the frontal visual attention area. Various tasks will be used to quantify attention and explore their relationship with asymmetries in functional connectivity. A qualitative comparison between the value of fMRI and TEPs for predicting attentional bias will be made.

Outcome Measures

  • Behavioral measures of attention
  • TEP measures of functional connectivity
  • fMRI measures of functional connectivity

Study Type

Interventional

Enrollment (Actual)

45

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 Locations

    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

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 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:
  • Age 18 and older
  • Able to provide consent

For some sub-studies, we may limit participation by handedness or eye dominance.

EXCLUSION CRITERIA:

  • Any current major neurological or psychiatric disorder, such as, (but not limited to) stroke, Parkinson disease, Alzheimer disease, schizophrenia or major depression
  • Findings on neurological examination indicative of significant brain disease
  • Individuals with significant health problems, such as cardiovascular disease, malignancy, or connective tissue disorder
  • History of seizure, defined as a diagnosis by a health care provider of one or more epileptic seizures or an anecdotal history which, in the opinion of the PI, is suggestive of epileptic seizure. Any individual who answers other than negatively to the question, Have you ever had an epileptic seizure on screening will be questioned directly by the PI
  • Current oral use of a medication that lowers the seizure threshold such as neuroleptics, beta lactams, isoniazid, metronidazole, tricyclic or other antidepressants, or prescription stimulants
  • Individuals regularly taking medications that cause significant psychomotor activation or depression, e.g., stimulants and CNS depressant drugs such as benzodiazepines, will be excluded.
  • For MRI studies: Any metal in the body which would make having an MRI scan unsafe, such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, any individual who was a welder or metal worker. Participants will also be excluded if they are uncomfortable in small closed spaces (i.e. claustrophobia) or are not able to lie comfortably on their back for up to two hours
  • Pregnancy or plans to become pregnant in the next two months
  • Members of the Behavioral Neurology Unit, NINDS
  • Use of illegal drugs in the past year
  • Consumption of more than 7 alcoholic drinks a week for females or 14 alcoholic drinks a week for males.

There is no general exclusion for NIH employees. Inclusion/exclusion criteria will be checked before enrollment in each sub-study to ensure that participants remain eligible.

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Volunteers
thematic permission to use non-invasive techniques regarded as having minimal risk in healthy individuals, such as, MRI, EEG, EMG, low-frequency stimulation (= 1 Hz), electrical stimulation of the skin to mimic the somatosensory artifact of TMS, and behavioral tests
attempt to use TMS EEG to measure connectivity between cortical areas
compare measurements to established functional connectivity measures; e.g., EEG coherence and fMRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory sub-studies under this protocol will answer questions about how to optimize EEG recordings of the cortical response to TMS.
Time Frame: 20 visits
Response to TMS
20 visits

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Actual)

February 28, 2019

Primary Completion (Actual)

October 24, 2022

Study Completion (Actual)

October 24, 2022

Study Registration Dates

First Submitted

December 27, 2018

First Submitted That Met QC Criteria

December 27, 2018

First Posted (Actual)

December 28, 2018

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 24, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 190036
  • 19-N-0036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

.Data sharing at an independent subject level may not be feasible.

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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