Development of Non-Invasive Brain Stimulation Techniques
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|ClinicalTrials.gov Identifier: NCT03351764|
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : July 1, 2022
Noninvasive brain stimulation (NIBS) may help diagnose and treat psychiatric and neurological illness. But there is not enough research on how to apply NIBS. This includes how strong to make it, where on the brain to apply it, and for how long. Researchers also want to see what the brain is doing when it receives NIBS.
To increase the effectiveness of NIBS.
Healthy native English speakers ages 18-65
Participants will be screened under another protocol with:
Medical and psychiatric history
All participants will start with a 2-hour visit for screening. (see below). They may learn how to do tasks that will be used later. After the screening session, they will be scheduled for an MRI session.
The next part of the study is 4 substudies. Each substudy includes up to 4 sessions. A session is usually 2-3 hours but can last up to 8 hours. Participants can join multiple substudies, but only 1 at a time. They can do only 1 session on a given day.
Each substudy includes the following:
Behavioral tests: Interviews; questionnaires; simple tasks; and tests of memory, attention, and thinking
Electromyography: Small sticky electrodes on the skin measure muscle activity.
Transcranial magnetic stimulation: A wire coil is held to the scalp. A brief electrical current passes through the coil and affects brain activity.
Magnetic resonance imaging (MRI): Participants lie on a table that slides into a machine that takes pictures of the brain. A coil is placed over the head. They will perform simple tasks while in the scanner. They may also get TMS.
Electroencephalography: Small electrodes on the scalp record brain waves.
Sponsoring Institution: National Institute of M
|Condition or disease||Intervention/treatment||Phase|
|Normal Physiology||Device: Sham TMS Device: TMS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Single Group Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Development of Non-Invasive Brain Stimulation Techniques|
|Actual Study Start Date :||January 11, 2018|
|Estimated Primary Completion Date :||January 1, 2029|
|Estimated Study Completion Date :||March 1, 2029|
these are within subject repeated measures studies across a number of conditions
non-invasive transcranial magnetic stimulation is used to temporarily modulation ongoing cortical activity
|Placebo Comparator: arm 2||
Device: Sham TMS
Subjects receive sham TMS via coil designed to produce the clicking sound of active TMS without delivering the magnetic field to the brain.
- behavioral performance (e.g., reaction time, accuracy) [ Time Frame: within session ]performance is compared across conditions
- TMS evoked potentials [ Time Frame: within session ]EEG evoked by TMS is compared across conditions
- Motor evoked potential amplitude [ Time Frame: within session ]EMG evoked by TMS is compared across conditions
- MRI activation (BOLD response) [ Time Frame: within session ]BOLD response is compared across conditions
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): NCT03351764
|Contact: Hannah S Gura||(301) email@example.com|
|Contact: Sarah H Lisanby, M.D.||(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:||Sarah H Lisanby, M.D.||National Institute of Mental Health (NIMH)|