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New treatment option for Healthy Volunteers
Official title Mechanism of Non-invasive Magnetic Stimulation
ClinicalTrials.gov ID: NCT03394066
What this study is testing
- What it's testing
- Background: Transcranial magnetic stimulation (TMS) is form of non-invasive brain stimulation. It is approved to treat depression.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- people must be:
- 18 - 60 years of age. -Justification: Many neural processes change with age, and these changes could introduce unwanted variability in both...
- In good health.
- Justification: Many illnesses may alter neural functioning as well as fMRI signals.
- Screening tools: Vital Signs, height/weight measurements, Medical History, Physical Examination, and lab tests. Labs may include, but are not limited...
You likely can't join if
- Personal history of stroke, brain lesions, previous neurosurgery, any personal history of seizure or fainting episode of unknown cause, or head...
- Justification: Stroke or head trauma can lower the seizure threshold and are therefore contraindications for TMS. Fainting episodes or syncope of...
- Screening tool: TMS safety questionnaire and History and Physical including a neurological exam.
- First-degree family history of any form of epilepsy with a potentially hereditary basis.
- Justification: First-degree family history of epilepsy with a hereditary component increases the risk of the participant having an undiagnosed...
- Screening tool: TMS safety screening, Medical History.
See the full eligibility criteria
Who can join
- people must be:
- 18 - 60 years of age. -Justification: 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...
- In good health.
- Justification: Many illnesses may alter neural functioning as well as fMRI signals.
- Screening tools: Vital Signs, height/weight measurements, Medical History, Physical Examination, and lab tests. Labs may include, but are not limited to: CBC, Hemoglobin A1C, CMP, ESR, and salivary HIV (blood may be...
- Right-handed.
- Justification: Using right-handed individuals will reduce variability in BOLD MRI data.
- Screening tool: self-report.
What rules you out
- 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...
- Justification: Stroke or head trauma can lower the seizure threshold and are therefore contraindications for TMS. Fainting episodes or syncope of unknown cause could indicate an undiagnosed condition associated with...
- Screening tool: TMS safety questionnaire and History and Physical including a neurological exam.
- First-degree family history of any form of epilepsy with a potentially hereditary basis.
- Justification: First-degree family history of epilepsy with a hereditary component increases the risk of the participant having an undiagnosed condition that is associated with lowered seizure threshold.
- Screening tool: TMS safety screening, Medical History.
- Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, -shunts...
- Justification: Any metal around the head is a contraindication for both MRI and TMS, as both methods involve exposure to a relatively strong magnetic field.
- Screening tool: TMS safety screening, MRI safety screening, Medical History.
- Any contraindications to MRI or TMS.
- Justification: There are additional contraindications that would exclude participation in MRI or TMS (e.g., claustrophobia).
- Screening tool: MRI safety screening, TMS Safety Screening, and mock scanner trial (if deemed necessary).
- Noise-induced hearing loss or tinnitus.
- Justification: individuals with noise-induced hearing problems may be particularly vulnerable to the acoustic noise generated by TMS and MRI equipment.
- Screening tools: TMS safety screening.
- 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.
- Justification: The use of certain medications or drugs can lower seizure threshold and is therefore contraindicated for TMS.
- Screening tools: MRI safety screening questionnaire and Medical history. A Urine toxicology that analyzes for presence of a broad range of prescription and nonprescription drugs may also be completed per the NIDA IRP...
- Lifetime history of major depressive disorder, schizophrenia, bipolar disorder, mania, or hypomania.
- Justification: The population of interest here is a healthy control population with no psychiatric disorders. In people with depression, bipolar disorder, mania or hypomania, there is a small chance that TMS can trigger...
- Screening tools: a mental health screening questionnaire and /or a semi-structured or structured psychiatric interview such as the Structured Clinical Interview for the DSM (SCID) or clinician assessment. Potential...
- 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.
- Justification: The population of interest here is a healthy control population with no substance use disorder and therefore a minimal nicotine exposure history in the control group is required.
- Screening tools: Self-report and CO \< 6. A commercial urine cotinine test may also be used, with the expectation that results correspond to non-smoker status for the specific test being used, typically corresponding to...
- Meet current DSM-5 criteria for any substance use disorder, smoke daily, or urine toxicology positive for any illicit substance inconsistent with history given.
- Justification: The population of interest here is a healthy control population with no substance use disorder. Current use of illicit substances could lower seizure threshold and is therefore contraindicated for TMS.
- Screening tools: a drug use survey (DUS) and urine qualitative drug screen for common drugs of abuse. SUD may also be evaluated in a structured/semi-structured psychiatric interview such as the SCID and follow up with a...
- Have met DSM-5 criteria for any substance use disorder in the past.
- Justification: the population of interest here is a healthy control population with no present or past substance use disorder.
- Screening tools: a drug use survey (DUS) and/or a structured/semi-structured psychiatric interview such as the SCID and follow up with a mental health professional).
- Pregnant individuals or those with reproductive potential who are sexually active and not using an acceptable form of contraception.
- Justification: it is unknown whether TMS or MRI poses a risk to fetuses.
- Screening tool: Medical assessments (urine pregnancy test) at the beginning of each visit that involves TMS or MRI.
- Participation in a TMS session less than two weeks ago.
- Justification: in order to limit exposure to TMS, we will not enroll people who have received TMS less than two weeks ago.
- Screening tool: TMS safety screening questionnaire, and/or medical history.
- History of learning disability, current ADHD or cognitive impairment
- Justification: Cognitive impairment and learning disabilities are associated with alterations in brain regions and may introduce significant variably into the data.
- Screening tool: self-report of special education classes, history of specific learning disability or mental retardation, and medical history. A validated IQ test such as Wechsler Abbreviated Scale of Intelligence (WASI)...
- Non-English Speaking
- Justification: There is no direct benefit to participants in this study, and some of the study procedures involve more than minimal risk. To include non-English speakers, we would have to translate the consent and other...
- Screening tool: self-report.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.