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Brain Stimulation and Vision Testing

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ClinicalTrials.gov Identifier: NCT01617408
Recruitment Status : Recruiting
First Posted : June 12, 2012
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Brief Summary:

Background:

- The brain has two systems for recognizing objects. One system recognizes what an object is, and the other system recognizes where the object is located. However, there is much about how the brain handles and interprets the information from these two systems that is still unclear. Researchers want to study the parts of the brain that are involved in how vision is processed. They will use magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS) on the brain. MRI measures what parts of the brain become more active when tasks are performed. TMS uses magnetic pulses to temporarily change the activity in parts of the brain.

Objectives:

- To better understand how people visually recognize different types of objects.

Eligibility:

- Healthy volunteers between 18 and 50 years of age.

Design:

  • This study includes many different experiments on vision. Each experiment may combine visual tasks, MRI scans, and TMS. Participants may be asked to have several different tests. Each test will require a separate visit to the National Institutes of Health.
  • Participants will be screened with a physical exam and medical history. They will have a baseline brain scan at the first visit.
  • Participants may do visual tasks alone, with MRI only, with TMS only, or with MRI and TMS combined. For the visual tasks, they will look at pictures of objects on a computer screen. Sometimes the images will appear very briefly (less than one-tenth of a second). Sometimes they will appear for up to 5 seconds. These images will be of things like faces, bodies, tools, and scenes. Participants will be asked to respond in different ways to the pictures. They may respond by typing on a computer keyboard or by pressing a button. Participants will have time to practice the tasks before the experiment.
  • Participants will remain on the study for up to 3 years.

Condition or disease
Transcranial Magnetic Stimulation (TMS) Visual System fMRI Dorsal Pathway Ventral Pathway

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Study Type : Observational
Estimated Enrollment : 345 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: TMS Investigations of the Human Visual System
Actual Study Start Date : March 4, 2013

Group/Cohort
1
Neurologically normal subjects aged 18 to 50 years old



Primary Outcome Measures :
  1. Online behavioral TMS experiments: performance accuracy, sensitivity and reaction time (RT); Offline fMRI TBS experiments: taskperformance as well as reduced neuronal activity [ Time Frame: Ongoing ]
    a. Behavioral TMS experiments will measure the speed of a key press to indicate the correct answer and performance accuracy onthe task.b. Offline TMS that combine TBS with fMRI will measure changes in BOLD activation in the targeted region as well as in connected cortical areas identified with an independent localizer.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Neurologically normal subjects aged between 18 and 50 years old.
Criteria
  • INCLUSION CRITERIA:

Healthy

Ages 18-50 years (inclusive)

EXCLUSION CRITERIA:

Individuals with conditions that could pose a risk relating to the safety of the MRI procedure, the TMS procedure or the combined TBS and fMRI procedure will be excluded from the protocol such as:

  • Those with ferromagnetic metal in the cranial cavity or eye, e.g. aneurysm clip, implanted neural stimulator, cochlear implant, ocular foreign body.
  • Those with an abnormality on a structural MRI.
  • Those with an implanted cardiac pacemaker or auto-defibrillator
  • Those with an insulin pump.
  • Those with an irremovable body piercing
  • Pregnant women
  • Those with a visual impairment that will prevent them from performing the task
  • Those without consent capacity will not be enrolled
  • Those who do not understand the study instructions
  • Those with a history of neurological problems. Neurological problems include, but are not limited to; family history of epilepsy, history of seizures and recurrent migraines.
  • Those using medicines that can lower the seizure threshold. These can include but are not limited to; imipramine, amitriptyline, doxepine, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines.
  • Those with a visual impairment that will prevent them from performing the task
  • Those who have a significant psychiatric illness or have a history of psychiatric illness.
  • NIMH employees

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617408


Contacts
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Contact: NIMH LBC Volunteer (301) 827-5157 nimhlbcvolunteer@mail.nih.gov
Contact: Christopher I Baker, Ph.D. (301) 435-6058 bakerchris@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Christopher I Baker, Ph.D. National Institute of Mental Health (NIMH)
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT01617408    
Other Study ID Numbers: 120128
12-M-0128
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: April 27, 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
Theta Burst Stimulation
Transcranial Magnetic Stimulation (TMS)
Visual Cortex
Visual Processing