- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03789201
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
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Publications and helpful links
Helpful Links
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
- 190036
- 19-N-0036
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Clinical Trials on Normal Physiology
-
Massachusetts General HospitalRecruitingNormal PhysiologyUnited States
-
National Institute of Environmental Health Sciences...Not yet recruiting
-
National Institute of Neurological Disorders and...RecruitingNormal PhysiologyUnited States
-
National Institute of Neurological Disorders and...RecruitingNormal PhysiologyUnited States
-
National Institute of Neurological Disorders and...CompletedNormal PhysiologyUnited States
-
National Center for Complementary and Integrative...Completed
-
National Cancer Institute (NCI)CompletedNormal PhysiologyUnited States
-
Sunnybrook Health Sciences CentreNot yet recruitingNormal Physiology
-
National Institute of Neurological Disorders and...National Institute for Biomedical Imaging and Bioengineering (NIBIB)RecruitingNormal PhysiologyUnited States
-
National Institute of Mental Health (NIMH)RecruitingNormal PhysiologyUnited States
Clinical Trials on TMS EEG
-
National Institute of Neurological Disorders and...CompletedElectrical Stimulation of the BrainUnited States
-
Medical University of South CarolinaColumbia University; University of Wisconsin, Madison; University of Oklahoma; Defense...Not yet recruiting
-
Wave NeuroscienceRecruitingStress Disorders, Post-TraumaticUnited States
-
QuantalX NeuroscienceCompletedStroke | Healthy | Cognitive Impairment | Dementia | Fibromyalgia | Cognitive Decline | MCI | TBI | Adhd | PDD | Ptsd | ABDIsrael
-
Butler HospitalTerminatedMood Disorders | Bipolar Disorder | Bipolar Depression | Major Depressive EpisodeUnited States
-
Rennes University HospitalCompleted
-
University of ZurichCompletedAltered Waking States of Consciousness in Healthy HumansSwitzerland
-
University of Dublin, Trinity CollegeMotor Neurone Disease Association, UK; Irish Research Council, IE; Thierry Latran... and other collaboratorsRecruitingMultiple Sclerosis | Amyotrophic Lateral Sclerosis | Frontotemporal DementiaIreland
-
Shalvata Mental Health CenterUnknown