NCT01375595

Brief Summary

Background: \- Studies have shown that animals such as monkeys and dogs have excellent sight and touch memory but perform poorly on sound memory tasks. Human brains have certain areas that are important for speaking and understanding language. These areas may be involved in sound and spoken word memory. Researchers want to study these areas of the brain to find out if the memory for sounds requires brain structures that are usually associated with language learning and are unique to humans. Objectives: \- To use magnetic resonance imaging to study areas of the brain involved in sound memory. Eligibility: \- Healthy right-handed volunteers between 18 and 50 years of age. They must be native English speakers and have completed high school. Design:

  • The study requires a screening visit and 1 or 2 study visits to the National Institutes of Health Clinical Center.
  • At the screening visit, volunteers will have a medical history taken. They will also have physical and neurological exams, and complete a questionnaire. Women of childbearing age will give a urine sample. Participants who have not had a magnetic resonance imaging (MRI) scan in the past year will have one at this visit.
  • At the second visit, participants will have tests of sound memory. They will listen to a set of nonsense words spoken through earphones and memorize the words. Then they will listen to the words again to judge if the words were part of the earlier list. Participants will have a 1 hour break, then do the sound memory test again. During the second test they will have repetitive transcranial magnetic stimulation (rTMS), which stimulates different regions of the brain.
  • If the group results from the testing sessions are positive, there will be a third visit. At this visit, participants will have a sound perception test. They will listen to words spoken through earphones and judge whether the words in the pair are the same or different. Participants will have rTMS during these tests as well.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2011

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

May 26, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2011

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2015

Completed
Last Updated

July 2, 2017

Status Verified

October 30, 2015

First QC Date

June 16, 2011

Last Update Submit

June 30, 2017

Conditions

Keywords

Working MemoryRepetitive TMS (rTMS)LanguageHealthy VolunteerHV

Outcome Measures

Primary Outcomes (1)

  • The primary outcome of this study is the error rate during the recognition memory task. The error rate is defined by the amount of stimuli that are correctly classified as familiar or unfamiliar.

Secondary Outcomes (1)

  • The secondary outcome measure of this study is the reaction time of participants to make judgments concerning the familiarity during the recognition memory task.

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • To be eligible for this research study participants must:
  • Be between the ages of 18 and 50 years of age
  • Be free of any neurologic condition that might affect performance of the tasks in these experiments
  • Be right handed
  • Be native English speakers
  • Have a finished high-school education or equivalent, such as GED

You may not qualify if:

  • Participants will be excluded from this research study if they:
  • Are taking medications that include antidepressants, anxiolytics, anticonvulsants, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines
  • Have a diagnosed neurologic or psychiatric condition
  • Have a history of seizure disorder
  • Have implanted devices such as pacemakers, medication pumps, or defibrillators, metal in the cranium except the mouth, intracardiac lines, history of shrapnel injury or any other condition/device that may contraindicate or preclude the acquisition of MRI
  • Have severe back pain or any other condition which might prevent them from lying flat for up to 1 hour
  • Have Claustrophobia (a fear of tight spaces), which prevents them from lying still in a tight or small space for up to 1 hour
  • Are currently pregnant
  • Have known hearing loss
  • Have an alcohol or substance abuse problem as determined by the screening we will do

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)

  • Aggleton JP, Brown MW. Interleaving brain systems for episodic and recognition memory. Trends Cogn Sci. 2006 Oct;10(10):455-63. doi: 10.1016/j.tics.2006.08.003. Epub 2006 Aug 28.

    PMID: 16935547BACKGROUND
  • Andoh J, Artiges E, Pallier C, Riviere D, Mangin JF, Cachia A, Plaze M, Paillere-Martinot ML, Martinot JL. Modulation of language areas with functional MR image-guided magnetic stimulation. Neuroimage. 2006 Jan 15;29(2):619-27. doi: 10.1016/j.neuroimage.2005.07.029. Epub 2005 Sep 15.

    PMID: 16168674BACKGROUND
  • Alloway TP, Alloway RG. Investigating the predictive roles of working memory and IQ in academic attainment. J Exp Child Psychol. 2010 May;106(1):20-9. doi: 10.1016/j.jecp.2009.11.003. Epub 2009 Dec 16.

    PMID: 20018296BACKGROUND

MeSH Terms

Conditions

Language DisordersMemory DisordersLanguage

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCommunicationBehavior

Study Officials

  • Mark Hallett, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 17, 2011

Study Start

May 26, 2011

Study Completion

October 30, 2015

Last Updated

July 2, 2017

Record last verified: 2015-10-30

Locations