Central Nervous System DiseaseNCT00005004
Brain Processing of Language Meanings
An observational study of Central Nervous System Disease and Cerebrovascular Accident, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
This research trial will study discourse processing-that is, how the brain processes the meaning of language. It will examine, for example, how words and sentences are interpreted in cases where more than one meaning is possible. The study will include two parts: 1. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Central Nervous System Disease, Cerebrovascular Accident, Craniocerebral Trauma
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2000to Mar 2005
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All subjects will be between the ages of 18-80, fluent English speakers, premorbidly right handed, and literate for stimulus sentences that are written at a minimum of a 4th grade reading level. In addition, all subjects will have a minimum high school or GED education, sufficient hearing acuity (aided or unaided) and auditory comprehension to follow task instructions, adequate visual acuity (aided or unaided) to read at least 14 pt. print on a computer screen, and adequate dexterity to press keyboard keys in response to stimuli.
- Healthy subjects will have no history of mental, cognitive or other neurological deficits, adequate hearing and visual acuity (corrected or uncorrected) to follow task instructions and read at least 14 pt. print on a computer screen, and adequate dexterity to press keyboard keys to response stimuli. As with BD subjects, healthy subjects will be right handed, native English speakers, and literate for stimulus sentences. The Mini-Mental State Examination (Folstein et al., 1975) will be administered as a cognitive screen for healthy subjects, using a cut-off score of 27 (of total 30) for inclusion on the protocol.
- For prefrontal BD subjects, only adult patients with focal damage confined to the prefrontal lateral or orbitomedial areas of either or both hemispheres will be included in the study. Cortical damage will be determined on the bases of neurological and neuropsychological examinations and confirmed by MRI or CT studies. All patients with stroke and penetrating head injury will be tested at least 3 months post-onset of neurological damage to ensure a stable medical condition. All patients with resected brain tumor will have completed radiation therapy and regimen of steroid medication. Dates and course of radiation therapy will be documented.
- It should be emphasized that the BD subjects to be included on this protocol will have selective deficits (on the basis of neuropsychological test findings and screening to determine candidacy) and will be able to understand the purpose of our studies, the instructions for our tasks, and response demands. Patients who cannot understand the purpose of our studies, or the instructions or response demands of the tasks would not meet entry criteria. Only those subjects who pass the screening will be accepted on the protocol.
Who cannot join
- Healthy subjects will have no history of mental, cognitive or other neurological deficits.
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, 20892
About this study
Official title: Investigations in Discourse Processes
This research trial will study discourse processing-that is, how the brain processes the meaning of language. It will examine, for example, how words and sentences are interpreted in cases where more than one meaning is possible. The study will include two parts:
- An investigation of the role of the prefrontal cortex of the brain in discourse processing will compare test performance of patients with prefrontal cortex damage with that of healthy age-matched normal volunteers.
- An investigation of the role of aging in discourse processing will compare test performance of young healthy subjects (18 to 40 years old) with older healthy subjects (41 to 80 years old).
Read more
All study candidates-both normal volunteers and patients with brain damage-must be at least 18 years old, speak English as their native language, have a high school degree or equivalent (GED), read on a minimum fourth grade level and be right-handed.
Study candidates who have central nervous system disease, dysfunction or trauma will have a routine history and neurological examination. They will also undergo neuropsychological testing if they have not already done so. Patients with neurological damage who have not had a magnetic resonance imaging (MRI) scan within six months or a year will be asked to undergo this procedure.
Study participants will take verbal or written tests; sit in front of a computer screen and press computer keys in response to what they are shown; answer questions from an examiner, which may be tape-recorded; and fill out questionnaires. There will be rest breaks between tasks. The studies will be spread over three to four days, with sessions lasting from 30 minutes to three hours.
Read the detailed description
This protocol is designed to acquire a better understanding of the underlying cognitive mechanisms involved, and the roles of the prefrontal cortex and normal aging, on various aspects of discourse processing. For Phase 1 of the investigations, two investigations will be conducted: Study 1 will compare the performance of patients with prefrontal cortical damage with age-matched healthy controls; Study 2 will compare the performance of young healthy subjects with older healthy subjects in various aspects of on-line discourse processing. The primary focus of our investigations will be on the cognitive mechanism of suppression, which allows selection of appropriate meanings when information is ambiguous. A secondary focus will be on the cognitive processes involved in comprehending explicit and implicit information in stories and appreciating their thematic aspects. In addition, we are interested in learning how individuals comprehend visual (pictorial) versus propositional (textual) representations of relational language concepts (e.g., more/less, front/back). From a cognitive neuroscience perspective, our interests are in investigating the roles of both the prefrontal cortex (i.e., prefrontal lateral and orbitomedial areas of either hemisphere) and the normal aging process in these aspects of discourse processing. We predict that: (1) patients with frontal lobe lesions will have difficulty in suppressing mental activation of inappropriate meanings of ambiguous text at various points during ongoing processing; (2) aging reduces the efficiency of suppressing contextually inappropriate meanings of ambiguous text; (3) prefrontal cortex damage will have deleterious effects on processing implied information in stories and appreciating their thematic aspects, and (4) prefrontal cortex damage will impair visual rather than propositional representations of relational language concepts. Phase 2 of the investigations is designed to extend study into other aspects of text processing as well as expands to the study and analysis of discourse production. Our specific intents are to (1) investigate the processing and use of context when encountering garden path phenomena in text; (2) understand the nature of breakdowns in discourse production during story tell/retell using sequential pictorial stimuli that probe for temporal sequencing of events, cohesive ties, cause/effect relationships, anaphoric reference, inference, and gist; (3) understand what role the prefrontal cortex plays in its ability to formulate a coherent representation in narrative text inferencing tasks.
Our findings will be of value in contributing to knowledge about the neural representation of the cognitive mechanisms underlying various aspects of discourse processes; advancing clinical measurements that can pinpoint breakdowns in these processes as they occur in real time, and understanding the effects of normal aging on discourse processes.
- Conditions
- Central Nervous System Disease, Cerebrovascular Accident, Craniocerebral Trauma, Head Injury, Healthy, Stroke
- Keywords
- Cognitive Processes, Inferential Ambiguities, Language Processes, Lexical Ambiguities, Suppression Mechanism, Discourse Processes, Discourse Production Analysis, Magnetic Resonance Imaging, Prefrontal Cortex Function, Aging Effects, Garden Path Phenomena, Text Integration
- Medical subject headings
- Central Nervous System Diseases, Stroke, Craniocerebral Trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2000 (estimated)
- Study startMar 2000
- Study completionMar 2005
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 Central Nervous System DiseaseStudies of the same condition, open and under way.
- 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
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005004
- Sponsor's protocol ID
- 000096
- Other IDs
- 00-CC-0096
- Status last verified
- Mar 2005
- First submitted
- 23 Mar 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Faust ME, Gernsbacher MA. Cerebral mechanisms for suppression of inappropriate information during sentence comprehension. Brain Lang. 1996 May;53(2):234-59. doi: 10.1006/brln.1996.0046.
PubMed 8726535Mani K, Johnson-Laird PN. The mental representation of spatial descriptions. Mem Cognit. 1982 Mar;10(2):181-7. doi: 10.3758/bf03209220. No abstract available.
PubMed 7087782Rehak A, Kaplan JA, Weylman ST, Kelly B, Brownell HH, Gardner H. Story processing in right-hemisphere brain-damaged patients. Brain Lang. 1992 Apr;42(3):320-36. doi: 10.1016/0093-934x(92)90104-m.
PubMed 1606490
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigations in Discourse Processes
- ClinicalTrials.gov ID
- NCT00005004
- Acronym / sponsor ID
- 000096
- Conditions
- Central Nervous System Disease, Cerebrovascular Accident, Craniocerebral Trauma, Head Injury, Healthy, Stroke
- Keywords
- Cognitive Processes, Inferential Ambiguities, Language Processes, Lexical Ambiguities, Suppression Mechanism, Discourse Processes, Discourse Production Analysis, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Mar 2000
- Study completion
- Mar 2005
- First posted
- 24 Mar 2000 (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.
This research trial will study discourse processing-that is, how the brain processes the meaning of language. It will examine, for example, how words and sentences are interpreted in cases where more than one meaning is possible. The study will include two parts:
- An investigation of the role of the prefrontal cortex of the brain in discourse processing will compare test performance of patients with prefrontal cortex damage with that of healthy age-matched normal volunteers.
- An investigation of the role of aging in discourse processing will compare test performance of young healthy subjects (18 to 40 years old) with older healthy subjects (41 to 80 years old).
All study candidates-both normal volunteers and patients with brain damage-must be at least 18 years old, speak English as their native language, have a high school degree or equivalent (GED), read on a minimum fourth grade level and be right-handed.
Study candidates who have central nervous system disease, dysfunction or trauma will have a routine history and neurological examination. They will also undergo neuropsychological testing if they have not already done so. Patients with neurological damage who have not had a magnetic resonance imaging (MRI) scan within six months or a year will be asked to undergo this procedure.
Study participants will take verbal or written tests; sit in front of a computer screen and press computer keys in response to what they are shown; answer questions from an examiner, which may be tape-recorded; and fill out questionnaires. There will be rest breaks between tasks. The studies will be spread over three to four days, with sessions lasting from 30 minutes to three hours.
Detailed description
This protocol is designed to acquire a better understanding of the underlying cognitive mechanisms involved, and the roles of the prefrontal cortex and normal aging, on various aspects of discourse processing. For Phase 1 of the investigations, two investigations will be conducted: Study 1 will compare the performance of patients with prefrontal cortical damage with age-matched healthy controls; Study 2 will compare the performance of young healthy subjects with older healthy subjects in various aspects of on-line discourse processing. The primary focus of our investigations will be on the cognitive mechanism of suppression, which allows selection of appropriate meanings when information is ambiguous. A secondary focus will be on the cognitive processes involved in comprehending explicit and implicit information in stories and appreciating their thematic aspects. In addition, we are interested in learning how individuals comprehend visual (pictorial) versus propositional (textual) representations of relational language concepts (e.g., more/less, front/back). From a cognitive neuroscience perspective, our interests are in investigating the roles of both the prefrontal cortex (i.e., prefrontal lateral and orbitomedial areas of either hemisphere) and the normal aging process in these aspects of discourse processing. We predict that: (1) patients with frontal lobe lesions will have difficulty in suppressing mental activation of inappropriate meanings of ambiguous text at various points during ongoing processing; (2) aging reduces the efficiency of suppressing contextually inappropriate meanings of ambiguous text; (3) prefrontal cortex damage will have deleterious effects on processing implied information in stories and appreciating their thematic aspects, and (4) prefrontal cortex damage will impair visual rather than propositional representations of relational language concepts. Phase 2 of the investigations is designed to extend study into other aspects of text processing as well as expands to the study and analysis of discourse production. Our specific intents are to (1) investigate the processing and use of context when encountering garden path phenomena in text; (2) understand the nature of breakdowns in discourse production during story tell/retell using sequential pictorial stimuli that probe for temporal sequencing of events, cohesive ties, cause/effect relationships, anaphoric reference, inference, and gist; (3) understand what role the prefrontal cortex plays in its ability to formulate a coherent representation in narrative text inferencing tasks.
Our findings will be of value in contributing to knowledge about the neural representation of the cognitive mechanisms underlying various aspects of discourse processes; advancing clinical measurements that can pinpoint breakdowns in these processes as they occur in real time, and understanding the effects of normal aging on discourse processes.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- All subjects will be between the ages of 18-80, fluent English speakers, premorbidly right handed, and literate for stimulus sentences that are written at a minimum of a 4th grade reading level. In addition, all subjects will have a minimum high school or GED education, sufficient hearing acuity (aided or unaided) and auditory comprehension to follow task instructions, adequate visual acuity (aided or unaided) to read at least 14 pt. print on a computer screen, and adequate dexterity to press keyboard keys in response to stimuli.
- Healthy subjects will have no history of mental, cognitive or other neurological deficits, adequate hearing and visual acuity (corrected or uncorrected) to follow task instructions and read at least 14 pt. print on a computer screen, and adequate dexterity to press keyboard keys to response stimuli. As with BD subjects, healthy subjects will be right handed, native English speakers, and literate for stimulus sentences. The Mini-Mental State Examination (Folstein et al., 1975) will be administered as a cognitive screen for healthy subjects, using a cut-off score of 27 (of total 30) for inclusion on the protocol.
- For prefrontal BD subjects, only adult patients with focal damage confined to the prefrontal lateral or orbitomedial areas of either or both hemispheres will be included in the study. Cortical damage will be determined on the bases of neurological and neuropsychological examinations and confirmed by MRI or CT studies. All patients with stroke and penetrating head injury will be tested at least 3 months post-onset of neurological damage to ensure a stable medical condition. All patients with resected brain tumor will have completed radiation therapy and regimen of steroid medication. Dates and course of radiation therapy will be documented.
- It should be emphasized that the BD subjects to be included on this protocol will have selective deficits (on the basis of neuropsychological test findings and screening to determine candidacy) and will be able to understand the purpose of our studies, the instructions for our tasks, and response demands. Patients who cannot understand the purpose of our studies, or the instructions or response demands of the tasks would not meet entry criteria. Only those subjects who pass the screening will be accepted on the protocol.
Key exclusion criteria (1 listed)
- Healthy subjects will have no history of mental, cognitive or other neurological deficits.
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8726535Faust ME, Gernsbacher MA. Cerebral mechanisms for suppression of inappropriate information during sentence comprehension. Brain Lang. 1996 May;53(2):234-59. doi: 10.1006/brln.1996.0046.
- Background: PubMed 7087782Mani K, Johnson-Laird PN. The mental representation of spatial descriptions. Mem Cognit. 1982 Mar;10(2):181-7. doi: 10.3758/bf03209220. No abstract available.
- Background: PubMed 1606490Rehak A, Kaplan JA, Weylman ST, Kelly B, Brownell HH, Gardner H. Story processing in right-hemisphere brain-damaged patients. Brain Lang. 1992 Apr;42(3):320-36. doi: 10.1016/0093-934x(92)90104-m.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Central Nervous System Disease and Cerebrovascular Accident, run by National Institutes of Health Clinical Center (CC) 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 4 Mar 2008. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005004, 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 4 Mar 2008.