Mechanism of Non-invasive Magnetic Stimulation (NCT03394066) | Clinical Trial Compass
RecruitingNot Applicable
Mechanism of Non-invasive Magnetic Stimulation
United States70 participantsStarted 2018-09-19
Plain-language summary
Background:
Transcranial magnetic stimulation (TMS) is form of non-invasive brain stimulation. It is approved to treat depression. TMS may help decrease drug craving. It is important to understand how TMS affects the brain. Such a better understanding would help to design ways to treat drug addiction.
Objectives:
To learn how TMS affects the brain when it stimulates an area in the front of the brain. Also, to see how the stimulation affects the area stimulated and other connected areas.
Eligibility:
Healthy, right-handed adults ages 18-60 who are non-drug users.
Design:
Participants will be screened under protocol 06-DA-N415.
Participants will have at least 3 visits. The first visit will last about 3 hours. All other visits will last up to 6 hours. Participants cannot use drugs or alcohol at least 24 hours before a visit. They cannot have more than half a cup of a caffeinated drink at least 12 hours before a visit.
Each visit will include a brief medical history update, urine test for drugs and pregnancy (if female), a breath test for alcohol and smoking, and questionnaires.
Participants will have a TMS orientation visit. A wire coil will be placed on the head. An electrical current will pass through the coil to create a magnetic pulse that stimulates the brain.
The other visits will include 2 sessions of TMS-MRI. Participants will lie on a table that slides into a cylinder. The TMS coil and the MRI coil will be placed over the head. Pictures will be taken of the brain with and without stimulation.
Participants will complete a questionnaire about how they feel before and after each TMS session and in a follow-up call 1-3 days after their last session.
Who can participate
Age range18 Years ā 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Be 18 - 60 years of age.
āJustification: Many neural processes change with age, and these changes could introduce unwanted variability in both behavioral and MRI signals. In addition, the risk of difficult-to-detect medical abnormalities such as silent cerebral infarcts increases with age.
ā-Screening tool: History.
ā. Be in good health.
ā. Right-handed.
Exclusion criteria
ā. Personal history of stroke, brain lesions, previous neurosurgery, any personal history of seizure or fainting episode of unknown cause, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than two days.
ā. First-degree family history of any form of epilepsy with a potentially hereditary basis.
ā. Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, -shunts, stimulators, cochlear implants, or electrodes) or any other metal object in the body that precludes either MRI scanning or TMS intervention.
What they're measuring
1
effects of TMS on fMRI blood oxygen level-dependent (BOLD) responses, TMS induced changes on resting state functional connectivity, and their associations with relevant structural connectivity revealed by DTI.
ā. Current use (any use in the past 4 weeks, chronic use within 6 past six months) of any investigational drug or of any medications with psychotropic, anti or pro-convulsive action.
ā. Lifetime history of major depressive disorder, schizophrenia, bipolar disorder, mania, or hypomania.
ā. Current use of nicotine or history more than about 20 cigarettes or 20 instances of nicotine use in lifetime or history of daily nicotine use.