Exploring the Relationship Between Brain Asymmetry and Attention
2 other identifiers
interventional
45
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2018
CompletedFirst Posted
Study publicly available on registry
December 28, 2018
CompletedStudy Start
First participant enrolled
February 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2022
CompletedOctober 26, 2022
October 24, 2022
3.7 years
December 27, 2018
October 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Exploratory sub-studies under this protocol will answer questions about how to optimize EEG recordings of the cortical response to TMS.
Response to TMS
20 visits
Study Arms (1)
Healthy Volunteers
EXPERIMENTALthematic 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
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 and older
- Able to provide consent
- For some sub-studies, we may limit participation by handedness or eye dominance.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Links
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Eric M Wassermann, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2018
First Posted
December 28, 2018
Study Start
February 28, 2019
Primary Completion
October 24, 2022
Study Completion
October 24, 2022
Last Updated
October 26, 2022
Record last verified: 2022-10-24