Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study

NCT02231892 | Completed Results DMC FDA Device

• 2 other identifiers: 99991418614-DA-N186
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Keywords

Repetitive TMS (rTMS); Parameter Development; Cognitive Tasks; MRI (Magnetic Resonance Imaging)

Outcome Measures

Primary Outcomes (2)

• Behavioral Outcome Measure

  Behavioral effects of INTENSITY (Sham/100%MT/110%MT) and demand for cognitive control, DEMAND (High/Medium/Low), were planned to be quantified via correct response time (RT) and trial accuracy using R Project for Statistical Computing (package afex, function mixed (Singmannet al, 2015)). RT data were planned to be submitted to a linear mixed model with a random intercept per subject and fixed effects of INTENSITY and DEMAND. Accuracy data were planned to be submitted to a generalized linear mixed model with a binomial distribution and logit link function with a random intercept per subject and fixed effects of INTENSITY and DEMAND. During the Behavioral phase of the study, this data was collected before TMS, immediately after TMS, and 1 hour after TMS. During the MRI phase of the study, this data was only collected before TMS and immediately after TMS.

  3x per session in Behavioral phase (before TMS, immediately after TMS, and 1 hour after TMS), and 2x per session in MRI Phase (before TMS and immediately after TMS).

• Imaging Outcome Measures

  These measures include resting state (seed-based functional connectivity), Arterial Spin labeling (ASL), and MRI Spectroscopy (MRS). 1. Seed based - correlation coefficient changes 2. ASL - % change 3. MRS - % change

  Twice per session in MRI Phase (pre-TMS and immediately post-TMS)

Study Arms (2)

Real TMS

EXPERIMENTAL

rTMS (frequency and intensity)

Device: TMS

Sham TMS

SHAM COMPARATOR

Sham setting on coil

Device: TMS

Interventions

TMS DEVICE

HAC coil (real rTMS or sham rTMS)

Real TMS; Sham TMS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 \< 10.5 g/dl, white blood cell count (WBC) \< 2400/microl, liver function tests (LFTs) \> 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.

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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

Location

Limitations and Caveats

Data collection closed 9/17/2019. Data have not yet been analyzed due to personnel turnover. There are currently no resources to complete data analysis. Data were transferred to a repository protocol for future analysis when resources are available.

Results Point of Contact

• Title: Dr. Elliott Stein
• Organization: National Institute on Drug Abuse

estein@mail.nih.gov

443-740-2650

Study Officials

• Elliot Stein, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Model Details: Within-subject design with each subject completing up to 10 rTMS sessions.

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 4, 2014
• Study Start: September 3, 2014
• Primary Completion: January 3, 2019
• Study Completion: September 18, 2019
• Last Updated: February 24, 2020
• Results First Posted: February 24, 2020

Record last verified: 2019-09-18

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)