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Protocol Details

Optimizing and Exploring TMS-EEG Techniques

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

19-N-0036

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 35

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

TMS-Evoked Potential;
TMS;
fMRI;
Behavior;
Electroencephalogram (EEG)

Recruitment Keyword(s)

None

Condition(s)

Normal Physiology

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Device: TMS EEG
Device: TMS fMRI

Supporting Site

National Institute of Neurological Disorders and Stroke

Background:

Transcranial magnetic stimulation (TMS) activates brain cells. When this happens, the cells produce brain waves. These can be recorded with electrodes on the scalp. This can tell us about how TMS works and how the brain functions. Researchers want to learn more about the technique by testing healthy adults.

Objective:

To better understand how to use transcranial magnetic stimulation plus electroencephalography (EEG) to study the brain of healthy adults.

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.

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Eligibility

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Eric M. Wassermann, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)



Amelia G. Stapleton
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10 RM 7D48
10 CENTER DR
BETHESDA MD 20814
(301) 496-0220
amelia.stapleton@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT03789201

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