Brain MappingNCT01375595
Brain Areas Involved in Sound and Spoken Word Memory
An observational study of Brain Mapping and Language Disorder, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Mapping, Language Disorder, Adult
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2011to 30 Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: The Role of the Inferior Frontal Gyrus in Long-Term Auditory Memory a rTMS Study
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.
Read more
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.
Read the detailed description
Objective:
Humans are the only animals that use language to communicate with each other. Among many other requirements, humans need excellent auditory long-term memory to be able to master the complicated task of learning a language. It is still not completely understood which brain regions are involved in transferring auditory stimuli into long-term memory. The goal of this research proposal is to examine whether brain structures that are known to be essential in language production also play an important role in encoding auditory stimuli into long-term memory.
Study population:
We propose using repetitive transcranial magnetic stimulation (rTMS) to examine the role of
frontal and temporo-parietal cortical areas in the storage of auditory stimuli in long-term memory. The whole study will comprise three experiments. Each of the three experiments will consist of one to three sessions. Sessions 1 and 2 will be compulsory in every experiment. Session 3 will only be required if positive results are obtained in session 2. Every participant can only participate in one of the three planned experiments.
In Experiment 1, we will investigate the potential role of Broca s area in auditory memory. If we find that rTMS in Broca s area interferes with performance on the memory task, we will conduct a control (session 3) to determine whether or not the impairment was actually due to interference with stimulus perception rather than with memory, per se. We will conduct Experiment 2 to investigate the possible role of Wernicke s region in auditory memory. We will conduct Experiment 3 to investigate the role of the ventral premotor cortex (PMv) in auditory memory.
In experiment 2 and 3 we will also conduct the same control session 3, as in Experiment 1 if the rTMS impairs performance on the auditory memory task. All experiments will consist of two sessions and an additional, third session if rTMS-induced impairment is found. In that case all participants will be called back for the control experiment. During session 1, a neurological examination will be performed and a clinical, anatomical, and functional MRI (Magnetic Resonance Imaging) will be taken (functional MRI for second repeat of experiment 1 and for experiment 3). In session 2, rTMS will be used in an attempt to temporarily disrupt the function of Broca s area (experiment 1), the TPJ (experiment 2) or PMv (experiment 3) while participants are performing an auditory recognition memory task. By temporarily disrupting cortical functioning in those localized regions, we will be able to determine whether or not their function is crucial for encoding auditory stimuli into long-term memory. In the control session, to be conducted only if the experimental task yields a positive result (i.e., impairment), we will test auditory perception by asking participants to make same/different judgments on stimulus pairs (similar to those used in session 2) presented with a very short delay while using the same rTMS routine as in session 2.
By amendment, we wish to expand session 1 to include functional MRI (fMRI) imaging designed to identify and refine the targets for disruption by rTMS in the subsequent session: Broca s area (experiment 1), and PMv (experiment 3). Specifically, we intend to (1) repeat Experiment 1 of the approved protocol using fMRI localization in an additional 15 subjects, and (2) proceed with Experiment 3 as described in the original protocol, also with the addition of fMRI localization. Initial results in experiment 1 (Broca s area) fell just short of significance, possibly because anatomical landmarks are inconsistent between subjects (e.g., Amunts et al., 1999); an fMRI localizer in each subject could reduce this variability. Unlike in the previous protocol, session 1 can not be skipped if the subject has had a neurological exam and MRI in the past year (the exam may be skipped, but all subjects will need the fMRI). The maximum number of sessions per experiment will remain unchanged at three: 1) intake exam and anatomical/functional MRI, 2) rTMS, and 3) a control session only if a significant effect of rTMS is observed.
By amendment, we also wish to consider the three experiments to be independent, rather than each contingent on the outcome of the previous experiment(s). As outlined below (sections 2.3-2.5), experimental evidence implicates all three regions in the auditory-motor network under study. Preliminary evidence indicates a positive effect in experiment 2 (the TPJ), but this does not render experiment 3 moot. Therefore we wish to apply fMRI-targeted rTMS to Broca s area, and PMv, in independent experiments.
Outcome measures:
In session 2, the primary outcome measure will be the number of correctly remembered auditory stimuli. Secondary output will be reaction time during the recognition phase of the experiment.
In the control experiment (if conducted) the primary outcome measure will be the number of correct same/different judgments and, again, reaction time will be the secondary measure.
- Conditions
- Brain Mapping, Language Disorder, Adult, Healthy, Memory Disorder
- Keywords
- Working Memory, Repetitive TMS (rTMS), Language, Healthy Volunteer, HV
- Medical subject headings
- Language Disorders, Memory Disorders, Language
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study start26 May 2011
- Study completion30 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brain MappingStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark Hallett, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375595
- Sponsor's protocol ID
- 110182
- Other IDs
- 11-N-0182
- Status last verified
- 30 Oct 2015
- First submitted
- 16 Jun 2011
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 16935547Andoh 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.
PubMed 16168674Alloway 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.
PubMed 20018296
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Inferior Frontal Gyrus in Long-Term Auditory Memory a rTMS Study
- ClinicalTrials.gov ID
- NCT01375595
- Acronym / sponsor ID
- 110182
- Conditions
- Brain Mapping, Language Disorder, Adult, Healthy, Memory Disorder
- Keywords
- Working Memory, Repetitive TMS (rTMS), Language, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 26 May 2011
- Study completion
- 30 Oct 2015
- First posted
- 17 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective:
Humans are the only animals that use language to communicate with each other. Among many other requirements, humans need excellent auditory long-term memory to be able to master the complicated task of learning a language. It is still not completely understood which brain regions are involved in transferring auditory stimuli into long-term memory. The goal of this research proposal is to examine whether brain structures that are known to be essential in language production also play an important role in encoding auditory stimuli into long-term memory.
Study population:
We propose using repetitive transcranial magnetic stimulation (rTMS) to examine the role of
frontal and temporo-parietal cortical areas in the storage of auditory stimuli in long-term memory. The whole study will comprise three experiments. Each of the three experiments will consist of one to three sessions. Sessions 1 and 2 will be compulsory in every experiment. Session 3 will only be required if positive results are obtained in session 2. Every participant can only participate in one of the three planned experiments.
In Experiment 1, we will investigate the potential role of Broca s area in auditory memory. If we find that rTMS in Broca s area interferes with performance on the memory task, we will conduct a control (session 3) to determine whether or not the impairment was actually due to interference with stimulus perception rather than with memory, per se. We will conduct Experiment 2 to investigate the possible role of Wernicke s region in auditory memory. We will conduct Experiment 3 to investigate the role of the ventral premotor cortex (PMv) in auditory memory.
In experiment 2 and 3 we will also conduct the same control session 3, as in Experiment 1 if the rTMS impairs performance on the auditory memory task. All experiments will consist of two sessions and an additional, third session if rTMS-induced impairment is found. In that case all participants will be called back for the control experiment. During session 1, a neurological examination will be performed and a clinical, anatomical, and functional MRI (Magnetic Resonance Imaging) will be taken (functional MRI for second repeat of experiment 1 and for experiment 3). In session 2, rTMS will be used in an attempt to temporarily disrupt the function of Broca s area (experiment 1), the TPJ (experiment 2) or PMv (experiment 3) while participants are performing an auditory recognition memory task. By temporarily disrupting cortical functioning in those localized regions, we will be able to determine whether or not their function is crucial for encoding auditory stimuli into long-term memory. In the control session, to be conducted only if the experimental task yields a positive result (i.e., impairment), we will test auditory perception by asking participants to make same/different judgments on stimulus pairs (similar to those used in session 2) presented with a very short delay while using the same rTMS routine as in session 2.
By amendment, we wish to expand session 1 to include functional MRI (fMRI) imaging designed to identify and refine the targets for disruption by rTMS in the subsequent session: Broca s area (experiment 1), and PMv (experiment 3). Specifically, we intend to (1) repeat Experiment 1 of the approved protocol using fMRI localization in an additional 15 subjects, and (2) proceed with Experiment 3 as described in the original protocol, also with the addition of fMRI localization. Initial results in experiment 1 (Broca s area) fell just short of significance, possibly because anatomical landmarks are inconsistent between subjects (e.g., Amunts et al., 1999); an fMRI localizer in each subject could reduce this variability. Unlike in the previous protocol, session 1 can not be skipped if the subject has had a neurological exam and MRI in the past year (the exam may be skipped, but all subjects will need the fMRI). The maximum number of sessions per experiment will remain unchanged at three: 1) intake exam and anatomical/functional MRI, 2) rTMS, and 3) a control session only if a significant effect of rTMS is observed.
By amendment, we also wish to consider the three experiments to be independent, rather than each contingent on the outcome of the previous experiment(s). As outlined below (sections 2.3-2.5), experimental evidence implicates all three regions in the auditory-motor network under study. Preliminary evidence indicates a positive effect in experiment 2 (the TPJ), but this does not render experiment 3 moot. Therefore we wish to apply fMRI-targeted rTMS to Broca s area, and PMv, in independent experiments.
Outcome measures:
In session 2, the primary outcome measure will be the number of correctly remembered auditory stimuli. Secondary output will be reaction time during the recognition phase of the experiment.
In the control experiment (if conducted) the primary outcome measure will be the number of correct same/different judgments and, again, reaction time will be the secondary measure.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
The secondary outcome measure of this study is the reaction time of participants to make judgments concerning the familiarity during the recognition memory task.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 16935547Aggleton 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.
- Background: PubMed 16168674Andoh 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.
- Background: PubMed 20018296Alloway 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Hallett, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Mapping and Language Disorder, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01375595, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017; AzTrials last refreshed its copy on 6 Nov 2026.