N/A
N=104
Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study
Healthy Volunteer
Bottom Line
View on ClinicalTrials.gov: NCT02231892 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Behavioral Outcome Measure
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TMS (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute on Drug Abuse (NIDA)
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Behavioral Outcome Measure |
— | — |
| PRIMARY Imaging Outcome Measures |
— | — |
Summary
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.
Eligibility Criteria
- INCLUSION CRITERIA:
Subjects must:
- Be able to give valid informed consent
- Be 18 55 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 medical abnormalities such as silent cerebral infarcts increases with age.
- Screening tool: History. Government-issued forms of identification (e.g. driver s license, birth certificate) will be required when participant appears to be out of age range.
- Be in good health.
- Justification: Many illnesses may alter neural functioning as well as fMRI signals.
- Screening tools: Medical Assessment, Medical History and Physical Examination. Medical assessments include: Vital Signs, EKG, oral HIV test, height/weight measurements, urinalysis and blood sample. Tests on the blood sample include complete blood count (CBC), complete metabolic profile, thyroid-stimulating hormone (TSH), erythrocyte sedimentation rate (ESR), Serologic Test For Syphilis (STS) and HIV (if needed to confirm a positive salivary test for HIV). The following individual laboratory results will independently disqualify individuals: Cholesterol >250 mg/dl, Hemoglobin 3x normal, Human chorionic gonadotropin (HCG) positive, Casual serum glucose > 200 mg/dl, Urine protein > 1+. The medically accountable investigator (MAI) will retain discretion to exclude at less extreme values, depending on the clinical presentation. (Serum glucose over 140 mg/dl will be followed up with a fasting serum glucose assessment. Those with fasting glucose below 100 mg/dl may be considered for the protocol. Others will be rejected and referred for work-up.) MAI will make the final judgment on any questionable lab results.
- Right-handed.
- Justification: Using right-handed individuals will reduce variability in BOLD MRI data.
- Screening tool: Edinburgh Handedness Inventory.
- Estimated intelligence quotient (IQ) greater than or equal to 85
- Justification: Subjects must be able to perform a cognitively challenging task to a high standard.
- Screening tool: Wechsler Abbreviated Scale of Intelligence.
EXCLUSION CRITERIA
- 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 ma
Data sourced from ClinicalTrials.gov (NCT02231892). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.