Normal PhysiologyNCT03789201
Exploring the Relationship Between Brain Asymmetry and Attention
A study testing TMS EEG and TMS fMRI in people with Normal Physiology, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: People tend to pay more attention to one side of space than the other and this may be due to differences in the structure and function of the two sides of the brain. We are interested in whether we can detect those difference with magnetic resonance imaging (MRI), transcranial magnetic stimulation (TMS)… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Physiology
- What is being tested?
- TMS EEG and TMS fMRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2019to 24 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 and older
- Able to provide consent
- For some sub-studies, we may limit participation by handedness or eye dominance.
Who cannot join
- Any current major neurological or psychiatric disorder, such as, (but not limited to) stroke, Parkinson disease, Alzheimer disease, schizophrenia or major depression
- Findings on neurological examination indicative of significant brain disease
- Individuals with significant health problems, such as cardiovascular disease, malignancy, or connective tissue disorder
- History of seizure, defined as a diagnosis by a health care provider of one or more epileptic seizures or an anecdotal history which, in the opinion of the PI, is suggestive of epileptic seizure. Any individual who answers other than negatively to the question, Have you ever had an epileptic seizure on screening will be questioned directly by the PI
- Current oral use of a medication that lowers the seizure threshold such as neuroleptics, beta lactams, isoniazid, metronidazole, tricyclic or other antidepressants, or prescription stimulants
- Individuals regularly taking medications that cause significant psychomotor activation or depression, e.g., stimulants and CNS depressant drugs such as benzodiazepines, will be excluded.
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- For MRI studies: Any metal in the body which would make having an MRI scan unsafe, such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, any individual who was a welder or metal worker. Participants will also be excluded if they are uncomfortable in small closed spaces (i.e. claustrophobia) or are not able to lie comfortably on their back for up to two hours
- Pregnancy or plans to become pregnant in the next two months
- Members of the Behavioral Neurology Unit, NINDS
- Use of illegal drugs in the past year
- Consumption of more than 7 alcoholic drinks a week for females or 14 alcoholic drinks a week for males.
- There is no general exclusion for NIH employees. Inclusion/exclusion criteria will be checked before enrollment in each sub-study to ensure that participants remain eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
People tend to pay more attention to one side of space than the other and this may be due to differences in the structure and function of the two sides of the brain. We are interested in whether we can detect those difference with magnetic resonance imaging (MRI), transcranial magnetic stimulation (TMS), and electroencephalography (EEG).
Read more
Objective:
The purpose of the study is to understand how differences in brain structure may cause people to pay more attention to one side than the other.
Eligibility:
Healthy adults ages 18-35
Design:
Participants will be screened with a neurological exam.
Participants will have 2-3 visits for a total duration of about 7/8 hours.
Women of childbearing age must have a negative pregnancy test before each MRI scan.
Visits may include:
Physical exam
Tests of attention, and thinking
TMS. A brief electrical current will pass through a wire coil on the scalp. Participants will hear a click and may feel a pull. They may be asked to tense muscles or do tasks.
Magnetic resonance imaging (MRI) scan for a maximum of 1 hour. Participants will lie on a table that slides into a cylinder in a strong magnetic field. They will do tasks on a computer screen or lie still. They will get earplugs for loud noise.
EEG for no longer than 5 hours, with most lasting 3 hours. Gel and a cap with electrodes will be placed on the scalp. They will record brain waves while the participant gets TMS or does nothing.
Questions about participants dominant hand and about the MRI.
Read the detailed description
Objective
The goal of this protocol to explore correlations between lateralized individual differences in visual attentional preference and hemispheric asymmetries in functional connectivity between the frontal and parietal visual attention areas. To measure functional connectivity, resting state functional MRI and electroencephalographic (EEG) potentials evoked with transcranial magnetic stimulation (TMS) will be used. Protocol research will also attempt to validate the TMS-evoked EEG potentials against fMRI resting state functional connectivity.
Study Population
Up to 80 right-handed and right-eyed healthy volunteers, aged 18-35
Design
TMS evoked EEG potentials (TEPs) and fMRI will be used to measure functional connectivity between the posterior parietal cortex and the frontal visual attention area. Various tasks will be used to quantify attention and explore their relationship with asymmetries in functional connectivity. A qualitative comparison between the value of fMRI and TEPs for predicting attentional bias will be made.
Outcome Measures
- Behavioral measures of attention
- TEP measures of functional connectivity
- fMRI measures of functional connectivity
- Conditions
- Normal Physiology
- Being tested
- TMS EEG, TMS fMRI
- Keywords
- TMS-Evoked Potential, TMS, fMRI, Behavior, Electroencephalogram (EEG)
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMS EEGDevice
attempt to use TMS EEG to measure connectivity between cortical areas
TMS fMRIDevice
compare measurements to established functional connectivity measures; e.g., EEG coherence and fMRI
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | thematic permission to use non-invasive techniques regarded as having minimal risk in healthy individuals, such as, MRI, EEG, EMG, low-frequency stimulation (= 1 Hz), electrical stimulation of the skin to mimic the somatosensory artifact of TMS, and behavioral tests Receives: Device: TMS EEG; Device: TMS fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploratory sub-studies under this protocol will answer questions about how to optimize EEG recordings of the cortical response to TMS.
Response to TMS
Measured: 20 visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start28 Feb 2019
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal PhysiologyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Eric M Wassermann, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789201
- Sponsor's protocol ID
- 190036
- Other IDs
- 19-N-0036
- Status last verified
- 24 Oct 2022
- First submitted
- 27 Dec 2018
- Last updated
- 26 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: .Data sharing at an independent subject level may not be feasible.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Relationship Between Brain Asymmetry and Attention
- ClinicalTrials.gov ID
- NCT03789201
- Acronym / sponsor ID
- 190036
- Conditions
- Normal Physiology
- Keywords
- TMS-Evoked Potential, TMS, fMRI, Behavior, Electroencephalogram (EEG)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 28 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
People tend to pay more attention to one side of space than the other and this may be due to differences in the structure and function of the two sides of the brain. We are interested in whether we can detect those difference with magnetic resonance imaging (MRI), transcranial magnetic stimulation (TMS), and electroencephalography (EEG).
Objective:
The purpose of the study is to understand how differences in brain structure may cause people to pay more attention to one side than the other.
Eligibility:
Healthy adults ages 18-35
Design:
Participants will be screened with a neurological exam.
Participants will have 2-3 visits for a total duration of about 7/8 hours.
Women of childbearing age must have a negative pregnancy test before each MRI scan.
Visits may include:
Physical exam
Tests of attention, and thinking
TMS. A brief electrical current will pass through a wire coil on the scalp. Participants will hear a click and may feel a pull. They may be asked to tense muscles or do tasks.
Magnetic resonance imaging (MRI) scan for a maximum of 1 hour. Participants will lie on a table that slides into a cylinder in a strong magnetic field. They will do tasks on a computer screen or lie still. They will get earplugs for loud noise.
EEG for no longer than 5 hours, with most lasting 3 hours. Gel and a cap with electrodes will be placed on the scalp. They will record brain waves while the participant gets TMS or does nothing.
Questions about participants dominant hand and about the MRI.
Detailed description
Objective
The goal of this protocol to explore correlations between lateralized individual differences in visual attentional preference and hemispheric asymmetries in functional connectivity between the frontal and parietal visual attention areas. To measure functional connectivity, resting state functional MRI and electroencephalographic (EEG) potentials evoked with transcranial magnetic stimulation (TMS) will be used. Protocol research will also attempt to validate the TMS-evoked EEG potentials against fMRI resting state functional connectivity.
Study Population
Up to 80 right-handed and right-eyed healthy volunteers, aged 18-35
Design
TMS evoked EEG potentials (TEPs) and fMRI will be used to measure functional connectivity between the posterior parietal cortex and the frontal visual attention area. Various tasks will be used to quantify attention and explore their relationship with asymmetries in functional connectivity. A qualitative comparison between the value of fMRI and TEPs for predicting attentional bias will be made.
Outcome Measures
- Behavioral measures of attention
- TEP measures of functional connectivity
- fMRI measures of functional connectivity
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Device: TMS EEG, Device: TMS fMRIthematic permission to use non-invasive techniques regarded as having minimal risk in healthy individuals, such as, MRI, EEG, EMG, low-frequency stimulation (= 1 Hz), electrical stimulation of the skin to mimic the somatosensory artifact of TMS, and behavioral tests |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18 and older
- Able to provide consent
- For some sub-studies, we may limit participation by handedness or eye dominance.
Key exclusion criteria (12 listed)
- Any current major neurological or psychiatric disorder, such as, (but not limited to) stroke, Parkinson disease, Alzheimer disease, schizophrenia or major depression
- Findings on neurological examination indicative of significant brain disease
- Individuals with significant health problems, such as cardiovascular disease, malignancy, or connective tissue disorder
- History of seizure, defined as a diagnosis by a health care provider of one or more epileptic seizures or an anecdotal history which, in the opinion of the PI, is suggestive of epileptic seizure. Any individual who answers other than negatively to the question, Have you ever had an epileptic seizure on screening will be questioned directly by the PI
- Current oral use of a medication that lowers the seizure threshold such as neuroleptics, beta lactams, isoniazid, metronidazole, tricyclic or other antidepressants, or prescription stimulants
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 |
|---|---|---|
| TMS EEGattempt to use TMS EEG to measure connectivity between cortical areas | Device | Healthy Volunteers |
| TMS fMRIcompare measurements to established functional connectivity measures; e.g., EEG coherence and fMRI | Device | Healthy Volunteers |
Primary outcome
Exploratory sub-studies under this protocol will answer questions about how to optimize EEG recordings of the cortical response to TMS.
Time frame: 20 visits
Response to TMS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. .Data sharing at an independent subject level may not be feasible.
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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.
Eric M Wassermann, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
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 EEG and TMS fMRI in people with Normal Physiology, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 3 inclusion and 12 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 26 Oct 2022. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Exploratory sub-studies under this protocol will answer questions about how to optimize EEG recordings of the cortical response to TMS. (time frame: 20 visits). 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 26 Oct 2022.