Optimizing and Exploring TMS-EEG Techniques
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|ClinicalTrials.gov Identifier: NCT03789201|
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : September 27, 2019
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.
To better understand how to use transcranial magnetic stimulation plus electroencephalography (EEG) to study the brain of healthy adults.
Healthy adults ages 18 50
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:
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|
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.
We plan to recruit up to 500 healthy volunteers, aged 18 and over.
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.
- 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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
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
|Contact: Cynthia M Fioriti||(301) firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Eric M Wassermann, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|