NCT01260740

Brief Summary

Background: \- Two areas on the surface of the brain, the dorsolateral prefrontal cortex (DLPFC) and motor cortex (MC), play a key role during learning. Researchers are interested in determining the effect that transcranial magnetic stimulation (TMS) on the DLPFC and MC has on participants' performance of learning tasks. By studying the effect of TMS on reaction time, learning, and memory, researchers hope to better understand how to treat conditions such as Parkinson's disease and traumatic brain injury that affect these parts of the brain. Objectives:

  • To study the effects of transcranial magnetic stimulation on the dorsolateral prefrontal cortex and motor cortex.
  • To learn which areas of the brain are used to perform certain learning and memory tasks. Eligibility: \- Healthy, right-handed individuals between 18 and 70 years of age. Design:
  • Participants will be screened with a physical and neurological examination and a medical and psychiatric history.
  • Participants will be asked to take part in one of five different parts of this study. Most participants will have four 2-hour visits to the National Institutes of Health Clinical Center. Some participants (those involved in Part 5) will have only one 2-hour visit.
  • Parts 1 and 2 (four visits): Participants will have TMS, and then do a learning task that may provide a small monetary reward. On the first visit, before the TMS, participants will take an intelligence test based on reading aloud the words given on a card. Participants who have not had a routine magnetic resonance imaging (MRI) scan of the brain within the past year will also have a scan.
  • Parts 3 and 4 (four visits): Participants will have a functional MRI scan while doing a learning task that may provide a small monetary reward. On the first visit, before the functional MRI, participants will take an intelligence test based on reading aloud the words given on a card. Participants who have not had a routine magnetic resonance imaging (MRI) scan of the brain within the past year will also have a scan.
  • Part 5 (one visit): Participants will take an intelligence test based on reading aloud the words given on a card. Then, participants will have TMS followed by a functional MRI scan. During the functional MRI, participants will do a button-pressing task that may provide a small monetary reward.
  • Participants will also be asked to provide a small blood sample for genetic analysis.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
174

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

December 7, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2010

Completed
6.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2017

Completed
Last Updated

October 6, 2017

Status Verified

June 23, 2017

First QC Date

December 14, 2010

Last Update Submit

October 5, 2017

Conditions

Keywords

Traumatic Brain InjuryExplicit LearningPrimary Motor CortexDorsolateral Prefrontal CortexImplicit LearningHealthy VolunteerHV

Outcome Measures

Primary Outcomes (1)

  • We will examine the effects of reward and TBS and their interaction on measures of learning.

    One hour

Secondary Outcomes (1)

  • Secondary outcome measures will be how TBS and reward interact to alter the pattern of BOLD activation on MRI and the effects of relevant genetic variation on learning variables and BOLD activation.

    One hour

Eligibility Criteria

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

You may qualify if:

  • Healthy
  • Right-handed
  • Ages 18-70 (inclusive)
  • Have completed high school or college in an English speaking country.
  • All participants must have had a neurological examination by a NINDS physician within the last two years.
  • All participants in the fMRI experiments must also have had a clinical MRI within the last year.

You may not qualify if:

  • Individuals with conditions that could pose a risk relating to the safety of the MRI 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 implanted cardiac pacemaker or auto-defibrillator.
  • Those with an insulin pump.
  • Those with an irremovable body piercing.
  • Pregnant women
  • Individuals with conditions that could pose a risk relating to the safety of the TMS procedure will be excluded from the protocol such as:
  • Those with significant abnormality on neurological examination.
  • Those with metal in the cranial cavity or eye, e.g. aneurysm clip, implanted neural stimulator, cochlear implant, ocular foreign body.
  • Those with an implanted cardiac pacemaker or auto-defibrillator.
  • Those with an insulin pump.
  • Pregnant women
  • Individuals with conditions that could compromise our interpretation of the TBS and fMRI results will be excluded such as:
  • Those with significant abnormality on neurological examination.
  • Those who have a significant psychiatric illness or have a history of psychiatric illness.
  • +1 more criteria

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)

  • Arancio O, Chao MV. Neurotrophins, synaptic plasticity and dementia. Curr Opin Neurobiol. 2007 Jun;17(3):325-30. doi: 10.1016/j.conb.2007.03.013. Epub 2007 Apr 6.

    PMID: 17419049BACKGROUND
  • Aron AR, Gluck MA, Poldrack RA. Long-term test-retest reliability of functional MRI in a classification learning task. Neuroimage. 2006 Feb 1;29(3):1000-6. doi: 10.1016/j.neuroimage.2005.08.010. Epub 2005 Sep 1.

    PMID: 16139527BACKGROUND
  • Badgaiyan RD, Fischman AJ, Alpert NM. Striatal dopamine release in sequential learning. Neuroimage. 2007 Nov 15;38(3):549-56. doi: 10.1016/j.neuroimage.2007.07.052. Epub 2007 Aug 15.

    PMID: 17888684BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Eric M Wassermann, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2010

First Posted

December 15, 2010

Study Start

December 7, 2010

Study Completion

June 23, 2017

Last Updated

October 6, 2017

Record last verified: 2017-06-23

Locations