NCT01747200

Brief Summary

Background: \- The brain has natural rhythms called brain waves. An electroencephalogram (EEG) can record these rhythms. When people identify the picture of a familiar object shown on a computer screen, the communication between certain regions of the brain increases. An EEG can detect these communication brain waves. Transcranial magnetic stimulation (TMS) can affect these brain waves by slightly changing the brain s rhythms. Researchers want to see if changing brain rhythms with TMS interferes with the ability to identify pictures of familiar objects. This study will provide more information about how TMS can affect brain waves and behavior. Objectives: \- To see if TMS can interfere with the brain s ability to identify pictures of familiar objects. Eligibility: \- Healthy volunteers between 18 and 70 years of age. Design:

  • This study requires two visits to the clinical center. The first visit will last about 2 hours. The second visit will last about 4 hours.
  • Participants will be screened with a physical exam and medical history.
  • At the first visit, participants will have an object recognition test. Participants will look at pictures of several objects on a computer screen. They will then have to state whether the objects they see on the screen are familiar. The object recognition test will be done along with TMS.
  • At the second visit, participants will have an EEG while taking the object recognition test. Brain waves will be monitored during the test. They will then repeat the test while having repetitive TMS to study its effect on object recognition. The participants will then take the object recognition test alone for a final time. This will make sure that TMS effects (if any) on the ability to identify familiar object images are no longer present.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

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

Study Start

First participant enrolled

November 16, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2017

Completed
Last Updated

July 2, 2017

Status Verified

January 26, 2017

Enrollment Period

4.2 years

First QC Date

December 8, 2012

Last Update Submit

June 30, 2017

Conditions

Keywords

Repetitive TMS (rTMS)

Outcome Measures

Primary Outcomes (1)

  • Percentage of correct responses in the midline object recognition task.

    4 hours

Secondary Outcomes (1)

  • Threshold intensity for blocking object recognition

    4 hours

Interventions

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 - 70 years.
  • Able to give his/her own consent to participate in the study.

You may not qualify if:

  • Presence of cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain, cochlear implants, metal fragments in the eye.
  • Pregnancy or lactation.
  • History of any serious medical illness or hearing problems
  • Intake of medication that affect the central nervous system like anti depressants, antihistamines, antipsychotics, dopamine agonists, benzodiazepines and antiepileptics in the past 3 months.
  • Presence of neurological or psychiatric illnesses like brain tumor, migraine, depression, bipolar disorder, schizophrenia.
  • History of any seizure.
  • Use or abuse of any drug in the past 6 months or intake of more than 7 alcoholic drinks a week in females and more than 14 alcoholic drinks a week in males.
  • Presence of metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain or on blood vessels, cochlear implants, artificial heart valves or metal fragments in the eye as these make having an MRI unsafe.
  • Presence of metallic dental fillings which are likely to cause MRI artifacts
  • Uncomfortable being in a small space for up to 2 hours.
  • Unable to lie flat on the back for up to 2 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Adler G, Brassen S, Jajcevic A. EEG coherence in Alzheimer's dementia. J Neural Transm (Vienna). 2003 Sep;110(9):1051-8. doi: 10.1007/s00702-003-0024-8.

    PMID: 12928837BACKGROUND
  • Gerloff C, Andres FG. Bimanual coordination and interhemispheric interaction. Acta Psychol (Amst). 2002 Jun;110(2-3):161-86. doi: 10.1016/s0001-6918(02)00032-x.

    PMID: 12102104BACKGROUND
  • Gray CM, Singer W. Stimulus-specific neuronal oscillations in orientation columns of cat visual cortex. Proc Natl Acad Sci U S A. 1989 Mar;86(5):1698-702. doi: 10.1073/pnas.86.5.1698.

    PMID: 2922407BACKGROUND

Study Officials

  • Mark Hallett, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2012

First Posted

December 11, 2012

Study Start

November 16, 2012

Primary Completion

January 26, 2017

Study Completion

January 26, 2017

Last Updated

July 2, 2017

Record last verified: 2017-01-26

Locations