Cerebrovascular DisorderNCT00001288
Brain Blood Flow Studies of Language and Memory
An observational study of Cerebrovascular Disorder and Epilepsy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Positron Emission Tomography (PET) is a technique used to investigate the functional activity of the brain. The PET technique allows doctors to study the normal processes of the brain (central nervous system) of normal individuals and patients with neurologic illnesses without physical / structural damage to the… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Disorder, Epilepsy
- What is being tested?
- 15 O Water and FDG
- How many people
- 303 participants
- Where
- 1 siteUnited States
- Study dates
- May 1991to Jun 2003
- 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
- Normal Volunteers:
- The desired age range is 18 to 55 years.
- Subjects will have no history of head injury or other neurological disease and must not be taking any medication.
- Female subjects of childbearing potential will be administered a pregnancy test; these subjects will not be eligible for the study requiring 2 scans.
- All volunteers will read and sign the consent form.
- Patients:
- Patients will be selected from among those referred to the Clinical Epilepsy Section, NINDS for evaluation.
Who cannot join
- Patients with evidence of a progressive intracranial process, who are taking any drugs (except AEDs) that might affect the results, or active systemic disease will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Cerebral Blood Flow Studies of Language and Memory
Positron Emission Tomography (PET) is a technique used to investigate the functional activity of the brain. The PET technique allows doctors to study the normal processes of the brain (central nervous system) of normal individuals and patients with neurologic illnesses without physical / structural damage to the brain.
When a region of the brain is active, it uses more fuel in the form of oxygen and sugar (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and water. Blood carries fuel to the brain and waste products away from the brain. As brain activity increases blood flow to and from the area of activity increases also. Knowing these facts, researchers can use radioactive water (H215O) and PET scans to observe what areas of the brain are receiving more blood flow.
This study is designed to use positron emission tomography (PET) with radioactive water (H215O) to determine the areas of the brain associated with memory and language. Patients participating in the study will be made up of normal volunteers, patients with epilepsy, and patients with other abnormalities related to the surface of the brain (non-epileptic focal cortical dysfunctions).
Read the detailed description
This protocol will use positron emission tomography (PET) with H2015 and functional MRI to examine localization of memory and language in normal control subjects, and patients with localization-related epilepsy.
- Conditions
- Cerebrovascular Disorder, Epilepsy
- Being tested
- 15 O Water, FDG
- Keywords
- Positron Emission Tomography, Epilepsy, Stroke
- Medical subject headings
- Cerebrovascular Disorders, Epilepsy, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15 O WaterDrug
FDGDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startMay 1991
- Study completionJun 2003
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 Cerebrovascular DisorderStudies 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
- Enrolment
- 303 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001288
- Sponsor's protocol ID
- 910134
- Other IDs
- 91-N-0134
- Status last verified
- Jun 2003
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Albert MS, Butters N, Brandt J. Memory for remote events in alcoholics. J Stud Alcohol. 1980 Nov;41(11):1071-81. doi: 10.15288/jsa.1980.41.1071. No abstract available.
PubMed 7278254Milner B. Interhemispheric differences in the localization of psychological processes in man. Br Med Bull. 1971 Sep;27(3):272-7. doi: 10.1093/oxfordjournals.bmb.a070866. No abstract available.
PubMed 4937273Petersen SE, Fox PT, Posner MI, Mintun M, Raichle ME. Positron emission tomographic studies of the cortical anatomy of single-word processing. Nature. 1988 Feb 18;331(6157):585-9. doi: 10.1038/331585a0.
PubMed 3277066
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
- Cerebral Blood Flow Studies of Language and Memory
- ClinicalTrials.gov ID
- NCT00001288
- Acronym / sponsor ID
- 910134
- Conditions
- Cerebrovascular Disorder, Epilepsy
- Keywords
- Positron Emission Tomography, Epilepsy, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- May 1991
- Study completion
- Jun 2003
- First posted
- 4 Nov 1999 (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.
Positron Emission Tomography (PET) is a technique used to investigate the functional activity of the brain. The PET technique allows doctors to study the normal processes of the brain (central nervous system) of normal individuals and patients with neurologic illnesses without physical / structural damage to the brain.
When a region of the brain is active, it uses more fuel in the form of oxygen and sugar (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and water. Blood carries fuel to the brain and waste products away from the brain. As brain activity increases blood flow to and from the area of activity increases also. Knowing these facts, researchers can use radioactive water (H215O) and PET scans to observe what areas of the brain are receiving more blood flow.
This study is designed to use positron emission tomography (PET) with radioactive water (H215O) to determine the areas of the brain associated with memory and language. Patients participating in the study will be made up of normal volunteers, patients with epilepsy, and patients with other abnormalities related to the surface of the brain (non-epileptic focal cortical dysfunctions).
Detailed description
This protocol will use positron emission tomography (PET) with H2015 and functional MRI to examine localization of memory and language in normal control subjects, and patients with localization-related epilepsy.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- The desired age range is 18 to 55 years.
- Subjects will have no history of head injury or other neurological disease and must not be taking any medication.
- Female subjects of childbearing potential will be administered a pregnancy test; these subjects will not be eligible for the study requiring 2 scans.
- All volunteers will read and sign the consent form.
- Patients will be selected from among those referred to the Clinical Epilepsy Section, NINDS for evaluation.
Key exclusion criteria (1 listed)
- Patients with evidence of a progressive intracranial process, who are taking any drugs (except AEDs) that might affect the results, or active systemic disease will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 15 O Water | Drug | – |
| FDG | Drug | – |
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 7278254Albert MS, Butters N, Brandt J. Memory for remote events in alcoholics. J Stud Alcohol. 1980 Nov;41(11):1071-81. doi: 10.15288/jsa.1980.41.1071. No abstract available.
- Background: PubMed 4937273Milner B. Interhemispheric differences in the localization of psychological processes in man. Br Med Bull. 1971 Sep;27(3):272-7. doi: 10.1093/oxfordjournals.bmb.a070866. No abstract available.
- Background: PubMed 3277066Petersen SE, Fox PT, Posner MI, Mintun M, Raichle ME. Positron emission tomographic studies of the cortical anatomy of single-word processing. Nature. 1988 Feb 18;331(6157):585-9. doi: 10.1038/331585a0.
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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 Cerebrovascular Disorder and Epilepsy, 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 7 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 NCT00001288, 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.