Healthy VolunteerNCT02231892
Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study
A study testing TMS in people with Healthy Volunteer, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2014to 18 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Justifications: the risk of TMS for individuals with a heart condition is unknown.
- Screening tool: physical assessment (EKG), medical history.
- Pregnant women or women with reproductive potential who are sexually active and not using an acceptable form of contraception.
- Justification: it is unknown whether TMS poses a risk to fetuses.
- Screening tool: Medical assessments (urine pregnancy test) at the beginning of each visit that involves TMS or MRI.
- History of learning disability or current attention deficit hyperactivity disorder (ADHD)
- Justification: Subjects should be able to perform cognitive tasks to a high degree of accuracy, both in the MRI scanner and outside the scanner. Subjects with ADHD/LD may engage different neural circuitry even if they can perform the tasks.
- Screening tool: Wechsler Abbreviated Scale of Intelligence, Medical history, Adult ADHD Self-Report Scale.
- Participation in an rTMS session less than two weeks ago.
- Justification: in order to limit exposure to TMS, we will not enroll subjects who have received TMS less than two weeks ago.
- Screening tool: TMS safety screening questionnaire.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Drug Abuse
Baltimore, Maryland, 21224
About this study
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.
Read more
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.
Read the detailed description
Objective: To establish an effective repetitive transcranial magnetic stimulation (rTMS) protocol for stimulating circuits relevant for addiction. Specifically, we will develop stimulation parameters and outcome measures for rTMS of the anterior cingulate cortex (ACC) with a specialized TMS coil: the HAC coil (Brainsway Ltd.). Various parameters of rTMS stimulation (frequency and intensity) will be varied, and the sensitivity of behavioral tasks and MRI measures to this stimulation will be determined. The objective of this protocol is therefore to allow for the development, assessment and refinement of rTMS parameters for stimulating ACC targets. In addition, outcome measures will be developed to capture the effects of this stimulation. Results from this development protocol will be applied to subsequent cognitive imaging protocols.
Study population: Up to 50 healthy, non-smoking adults will be tested in several conditions over up to two weeks. Subjects must fit exclusion/inclusion criteria for TMS and MRI. We expect 140 subjects to be enrolled to arrive at a number of 50 who complete the protocol.
Design: Within-subject design with each subject completing up to 10 rTMS sessions.
Outcome measures: In a first phase, the outcome measure will be the behavioral response on a task that relies on the ACC. In a second phase, outcome measures will be the effects on MR measures. These will include task-related blood oxygen level-dependent (BOLD) responses, as well as resting state BOLD functional magnetic resonance imaging (fMRI). Other MR measures, such as magnetic resonance spectroscopy (MRS) and arterial spin labeling (ASL), will also be explored as potential biomarkers.
- Conditions
- Healthy Volunteer
- Being tested
- TMS
- Keywords
- Repetitive TMS (rTMS), Parameter Development, Cognitive Tasks, MRI (Magnetic Resonance Imaging)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
HAC coil (real rTMS or sham rTMS)
| Study group | Role | What they receive |
|---|---|---|
| Real TMS | Experimental | rTMS (frequency and intensity) Receives: Device: TMS |
| Sham TMS | Sham comparator | Sham setting on coil Receives: Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
- Seed based - correlation coefficient changes
- ASL - % change
- MRS - % change
Measured: Twice per session in MRI Phase (pre-TMS and immediately post-TMS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study start3 Sep 2014
- Primary completion3 Jan 2019
- Study completion18 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Within-subject design with each subject completing up to 10 rTMS sessions.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Elliot Stein, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231892
- Sponsor's protocol ID
- 999914186
- Other IDs
- 14-DA-N186
- Status last verified
- 18 Sep 2019
- First submitted
- 3 Sep 2014
- Last updated
- 24 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study
- ClinicalTrials.gov ID
- NCT02231892
- Acronym / sponsor ID
- 999914186
- Conditions
- Healthy Volunteer
- Keywords
- Repetitive TMS (rTMS), Parameter Development, Cognitive Tasks, MRI (Magnetic Resonance Imaging)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 3 Sep 2014
- Primary completion
- 3 Jan 2019 (actual)
- Study completion
- 18 Sep 2019 (actual)
- First posted
- 4 Sep 2014 (estimated)
- Results
- Posted 24 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective: To establish an effective repetitive transcranial magnetic stimulation (rTMS) protocol for stimulating circuits relevant for addiction. Specifically, we will develop stimulation parameters and outcome measures for rTMS of the anterior cingulate cortex (ACC) with a specialized TMS coil: the HAC coil (Brainsway Ltd.). Various parameters of rTMS stimulation (frequency and intensity) will be varied, and the sensitivity of behavioral tasks and MRI measures to this stimulation will be determined. The objective of this protocol is therefore to allow for the development, assessment and refinement of rTMS parameters for stimulating ACC targets. In addition, outcome measures will be developed to capture the effects of this stimulation. Results from this development protocol will be applied to subsequent cognitive imaging protocols.
Study population: Up to 50 healthy, non-smoking adults will be tested in several conditions over up to two weeks. Subjects must fit exclusion/inclusion criteria for TMS and MRI. We expect 140 subjects to be enrolled to arrive at a number of 50 who complete the protocol.
Design: Within-subject design with each subject completing up to 10 rTMS sessions.
Outcome measures: In a first phase, the outcome measure will be the behavioral response on a task that relies on the ACC. In a second phase, outcome measures will be the effects on MR measures. These will include task-related blood oxygen level-dependent (BOLD) responses, as well as resting state BOLD functional magnetic resonance imaging (fMRI). Other MR measures, such as magnetic resonance spectroscopy (MRS) and arterial spin labeling (ASL), will also be explored as potential biomarkers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Within-subject design with each subject completing up to 10 rTMS sessions.
| Arm | Type | Receives |
|---|---|---|
| Real TMS | Experimental | Device: TMSrTMS (frequency and intensity) |
| Sham TMS | Sham comparator | Device: TMSSham setting on coil |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Be able to give valid informed consent
- Be 18 55 years of age.
- Be in good health.
- Right-handed.
- Estimated intelligence quotient (IQ) greater than or equal to 85
Key exclusion criteria (36 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMSHAC coil (real rTMS or sham rTMS) | Device | Real TMS, Sham TMS |
Primary outcome
Behavioral Outcome Measure
Time frame: 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).
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.
Imaging Outcome Measures
Time frame: Twice per session in MRI Phase (pre-TMS and immediately post-TMS)
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elliot Stein, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS in people with Healthy Volunteer, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Outcome Measure (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.