Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study

Completed · Not applicable · Has a placebo group

Conditions studied: Healthy Volunteer

In brief

Background: \- Brain stimulation called repetitive transcranial magnetic stimulation (rTMS) may help people quit drugs. Researchers want to study how it works in healthy people first. Objective: \- To learn how to use rTMS to stimulate a brain area and to see how it affects brain function and thinking. Eligibility: \- Healthy, right-handed adults ages 18-55. Design: * Participants will be screened under another protocol. * They will have 4-11 study visits. * To start each visit, participants will have: * Physical exam. * Urine sample. * Breath tests for alcohol and cigarette smoke. * Questions about drug use and medications. * Visit 1: participants will have: * Single TMS pulses on the head to determine the right strength. They will wear earplugs and a cap. A wire coil will be placed on the head and an electrical current will go through it. Participants may perform simple muscle movements. They will repeat the procedures wearing another coil, in a helmet. * A few TMS pulses to show how rTMS feels. * A practice thinking task, maybe in a scanner that looks and sounds like a magnetic resonance imaging (MRI) scanner but does not take pictures. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. The participant will lie on a table that slides in and out of the cylinder. * They may have a real MRI scan. * Visits 2-11, participants will: * Complete two questionnaires. * Get varied rTMS stimulation. Their heart rate and blood pressure may be monitored. * Have their vital signs checked. * They may perform thinking tasks at a computer, in a mock scanner, or in an MRI scanner. They may just lie still in the MRI scanner.

Key facts

Study ID: NCT02231892
Run by: National Institute on Drug Abuse (NIDA)
People needed: 104
Starts: 2014-09-03
Expected to finish: 2019-09-18
Last updated by the study team: 2020-02-24

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

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.
Justification: Stroke or head trauma can lower the seizure threshold, and are therefore contra-indications for TMS. Fainting episodes or syncope of unknown cause could indicate an undiagnosed condition associated with seizures.
Screening tool: TMS adult safety questionnaire, Medical History.
First-degree family history of any neurological disorder with a potentially hereditary basis, including migraines, epilepsy, or multiple sclerosis.
Justification: Neurological disorders can lower the seizure threshold, and are therefore contra-indications for TMS. First-degree family history of certain neurological disorders with a hereditary component increases the risk of the subject having an undiagnosed condition that is associated with lowered seizure threshold.
Screening tool: TMS adult 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, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head that precludes MRI scanning.
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 adult safety screening, MRI safety screening, Medical History.
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 adult 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 contra-indicated for TMS.
Screening tools: MRI safety screening questionnaire, Medical history, Medical Assessments: Urine toxicology analyzes for presence of a broad range of prescription and nonprescription drugs.
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 subjects with depression, bipolar disorder, mania or hypomania, there is a small chance that TMS can trigger (hypo)manic symptoms.
Screening tools: Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID) Screen Patient Questionnaire. Potential diagnoses will be further evaluated by a counsellor.
Meet current Diagnostic and Statistical Manual (DSM) V criteria for moderate to severe substance use disorder (excluding nicotine), 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 impact on seizure threshold and is therefore contra-indicated for TMS.
Screening tools: SCID Screen Patient Questionnaire. Potential diagnoses will be further evaluated by a counsellor, Drug Use Survey (DUS), Substance Use Disorder Evaluation, Medical Assessments: urine qualitative drug screen is performed for methadone, benzodiazepines, cocaine, amphetamine/methamphetamine, opiates, barbiturates, and tetrahydrocannabinol.
Have met DSM V criteria for moderate to severe substance use disorder (excluding nicotine, alcohol and cannabis) in the past, or have met DSM V criteria for moderate to severe substance use disorder for cannabis or alcohol in the past 5 years.
Justification: the population of interest here is a healthy control population with no present or past substance use disorder.
Screening tools: SCID Screen Patient Questionnaire. Potential diagnoses will be further evaluated by a counselor. Drug Use Survey (DUS), Substance Use Disorder Evaluation.
History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or any heart condition currently under medical care.

Where it is running

National Institute on Drug Abuse — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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