NCT03789201

Brief 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), 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 28, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 28, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2022

Completed
Last Updated

October 26, 2022

Status Verified

October 24, 2022

Enrollment Period

3.7 years

First QC Date

December 27, 2018

Last Update Submit

October 25, 2022

Conditions

Keywords

TMS-Evoked PotentialTMSfMRIBehaviorElectroencephalogram (EEG)

Outcome Measures

Primary Outcomes (1)

  • Exploratory sub-studies under this protocol will answer questions about how to optimize EEG recordings of the cortical response to TMS.

    Response to TMS

    20 visits

Study Arms (1)

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

Device: TMS EEGDevice: TMS fMRI

Interventions

TMS EEGDEVICE

attempt to use TMS EEG to measure connectivity between cortical areas

Healthy Volunteers
TMS fMRIDEVICE

compare measurements to established functional connectivity measures; e.g., EEG coherence and fMRI

Healthy Volunteers

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 and older
  • Able to provide consent
  • For some sub-studies, we may limit participation by handedness or eye dominance.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

MeSH Terms

Conditions

Behavior

Study Officials

  • Eric M Wassermann, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2018

First Posted

December 28, 2018

Study Start

February 28, 2019

Primary Completion

October 24, 2022

Study Completion

October 24, 2022

Last Updated

October 26, 2022

Record last verified: 2022-10-24

Locations