Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Optimizing and Exploring TMS-EEG Techniques

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03789201
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Brief Summary:

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 50

Design:

Participants will be screened with a neurological exam.

Participants will have 1 20 visits of up to 8 hours each.

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

Visits may include:

Physical exam

Tests of memory, attention, and thinking

Electrical shocks from sticky disks with wires placed on the skin

Headphones that play white noise or a click

Muscle activity recorded by small disks attached to the skin

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 1 3 hours. 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 3 6 hours. Gel and a cap with electrodes will be placed on the scalp. They will record brain waves while the participant gets TMS, does a task, or does nothing.

Questions about participants dominant hand and about the MRI.


Condition or disease Intervention/treatment Phase
Normal Physiology Device: TMS EEG Device: TMS fMRI Not Applicable

Detailed Description:

Objective:

The goal of this thematic protocol is to optimize and develop the use of TMS-EEG as a method for measuring cortical connectivity and TMS-evoked EEG potentials. This protocol will also be used to train new members of our laboratory and pilot future hypothesis-driven studies. This protocol includes thematic permission to use non-invasive techniques regarded as having minimal risk in healthy individuals, such as, MRI, EEG, EMG, low-frequency stimulation (less than or equal to 1 Hz), electrical stimulation of the skin to mimic the somatosensory artifact of TMS, and behavioral tests.

Study Population:

We plan to recruit up to 500 healthy volunteers, aged 18 and over.

Design:

Exploratory sub-studies under this protocol will answer questions about how to optimize TMS- EEG and TMS-fMRI to obtain imaging or physiological outcomes. These studies will generally vary one parameter at a time in a systematic way and will use various statistical measures, such as effect size, to compare results obtained under different conditions.

Outcome Measures:

  • MRI/fMRI measures of anatomical and functional connectivity and activation
  • EEG measures of the response to TMS, connectivity between areas, and background activity
  • EMG measures of evoked muscle activity
  • Psychophysical and behavioral measures of brain system function

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Optimizing and Exploring TMS-EEG Techniques
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : August 12, 2029
Estimated Study Completion Date : January 31, 2038

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, lowfrequency stimulation(= 1 Hz), electrical stimulation of the skin to mimic thesomatosensory artifact of TMS, and behavioral tests
Device: TMS EEG
attempt to use TMS EEG to measure connectivity between cortical areas

Device: TMS fMRI
compare measurements to established functional connectivity measures; e.g., EEG coherence and fMRI




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789201


Contacts
Layout table for location contacts
Contact: Cynthia M Fioriti (301) 402-6921 cynthia.fioriti@nih.gov

Locations
Layout table for location information
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Layout table for investigator information
Principal Investigator: Eric M Wassermann, M.D. National Institute of Neurological Disorders and Stroke (NINDS)

Additional Information:
Layout table for additonal information
Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT03789201     History of Changes
Other Study ID Numbers: 190036
19-N-0036
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 5, 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
TMS-Evoked Potential
TMS
fMRI
Behavior
Electroencephalogram (EEG)