EpilepsyNCT00081432
Language and Emotional Function in Patients With Temporal Lobe Epilepsy
An observational study of Epilepsy and Temporal Lobe, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study uses functional magnetic resonance imaging (fMRI) and diffusion tensor imaging (DTI) to examine how the brain processes tasks involving language and emotion in normal volunteers and in patients with epilepsy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Temporal Lobe
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2004to 27 Apr 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient Group:
- Temporal lobe epilepsy (right-sided, left-sided foci) with or without lesion on a structural MRI scan.
- Native English speaker.
- Age 18 years or older.
- Signed informed consent.
- Volunteer Group:
Show all 9Show fewer
- Native English speaker.
- Age 18 years or older.
- Signed informed consent.
Who cannot join
- Patient Group:
- Medical or technical contraindications to MRI procedures (e.g. no braces, pacemakers, cochlear devices, surgical clips, etc;
- History of mental retardation;
- Pregnancy;
- Claustrophobia;
- Inability to comply with the protocol.
Show all 12Show fewer
- Volunteer Group:
- Medical or technical contraindications to MRI procedures (e.g. no braces, pacemakers, cochlear devices, surgical clips, etc.);
- History of neurologic or psychiatric disease or a learning or attention disorder or mental retardation.
- Pregnancy.
- Claustrophobia.
- Inability to comply with the protocol.
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: Functional MRI (fMRI) and Diffusion Tensor Imaging (DTI) in Temporal Lobe Epilepsy
This study uses functional magnetic resonance imaging (fMRI) and diffusion tensor imaging (DTI) to examine how the brain processes tasks involving language and emotion in normal volunteers and in patients with epilepsy. MRI is a diagnostic and research tool that uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The MRI scanner is a metal cylinder surrounded by a magnetic field. During the test, the subject lies on a table that can slide in and out of the cylinder. DTI involves taking pictures of the brain while the subject is at rest in order to learn about the structure of the brain. Information gained from this study will help scientists evaluate the organization of language and emotional functions in the brain.
Normal volunteers and patients with temporal lobe epilepsy 18 years of age and older who are native English speakers and who will undergo surgery for uncontrolled seizures may be eligible for this study. Candidates are initially screened by telephone, then with physical and neurologic examinations and cognitive testing.
Read more
The study has two parts, conducted 6 to 12 months apart. Each part consists of the same sets of tests described below, using fMRI and DTI. In patients with epilepsy, Part 1 is scheduled before surgery and Part 2 after surgery.
- fMRI: Subjects are asked to perform two types of tasks while they undergo fMRI. In one task, they are shown pictures of animals and tools and are asked to name them. In a second task, they are shown pictures that range in content from sexually explicit material, to human injury and surgical slides, to pleasant images of children and wildlife and are asked to decide whether they find the pictures pleasant, neutral, or unpleasant.
- DTI: Subjects relax and remain still in the MRI scanner for about 45 minutes.
- Neuropsychological testing: Subjects may be asked to complete questionnaires, take pen-and-paper or computerized tests, and perform motor tasks.
Participants may be asked to repeat the MRI studies, but not the neuropsychological tests, up to four times to investigate different brain functions or to confirm findings.
Read the detailed description
OBJECTIVES: Epilepsy surgery is emerging as a potent therapeutic intervention for a large group of patients with uncontrolled temporal lobe epilepsy, particularly when performed early in the course of the illness. Seizure freedom is an important goal of seizure surgery, but post-operative neuropsychological functioning is another equally important outcome measure. Both endpoints require careful pre-operative evaluation of the individual patient and better understanding of the functional neuroanatomy of the temporal lobe. In this study fMRI and DTI will be performed in patients with temporal lobe epilepsy and normal volunteers in an attempt to
- investigate the role of the anterior temporal cortex in semantic processing,
- evaluate the role of the amygdala in affective processing,
- correlate the extent of white matter pathway resection with cognitive outcome after temporal lobectomy.
STUDY POPULATION: We plan to study 30 patients with temporal lobe epilepsy (right-sided, left-sided seizure foci) pre and post temporal lobectomy as well as 30 normal volunteers.
DESIGN: The study will be done in two parts both consisting of identical tasks. For the patient group part 1 will be performed prior to temporal lobectomy and part 2, 6-12 months after temporal lobectomy. For the normal volunteer group parts 1 and 2 will be performed at time interval of 6-12 months.
During part 1 all study subjects will undergo neuropsychological evaluation. FMRI will be performed with two tasks: animal and tool naming (to evaluate semantic processing) and rating of emotionally pleasant or unpleasant pictures (to evaluate affective processing). All subjects will also undergo diffusion tensor imaging (DTI) for the visualization of white matter pathways.
During part 2 of the study all of the above tests will be repeated.
FMRI data will be analyzed within the framework of the general linear model in a program such as AFNI 2.5. Statistical comparisons between activation patterns in scans acquired during part 1 and part 2 within either group (intragroup comparison) will be done by voxel wise paired t-test. In a second analysis all 4 groups will be compared in a mixed model. The DTI data will be correlated with the neuropsychological outcome to asses the contribution of white matter abnormalities pre-operatively or severance of white matter pathways post-operative on neuropsychological functioning.
OUTCOME PARAMETERS: Outcome parameters are changes in the fMRI activation pattern post temporal lobectomy and disruption of anisotropy on the diffusion tensor images.
- Conditions
- Epilepsy, Temporal Lobe
- Keywords
- Seizures, Language, Memory, Brain, Imaging, Epilepsy, Temporal Lobe Epilepsy
- Medical subject headings
- Epilepsy, Seizures, Language, Epilepsy, Temporal Lobe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2004 (estimated)
- Study start9 Apr 2004
- Study completion27 Apr 2010
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 EpilepsyStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00081432
- Sponsor's protocol ID
- 040159
- Other IDs
- 04-N-0159
- Status last verified
- 27 Apr 2010
- First submitted
- 10 Apr 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Barnes PD. Imaging of the central nervous system in pediatrics and adolescence. Pediatr Clin North Am. 1992 Aug;39(4):743-76. doi: 10.1016/s0031-3955(16)38374-2.
PubMed 1635805Basser PJ, Pajevic S, Pierpaoli C, Duda J, Aldroubi A. In vivo fiber tractography using DT-MRI data. Magn Reson Med. 2000 Oct;44(4):625-32. doi: 10.1002/1522-2594(200010)44:43.0.co;2-o.
PubMed 11025519Basser PJ, Pierpaoli C. A simplified method to measure the diffusion tensor from seven MR images. Magn Reson Med. 1998 Jun;39(6):928-34. doi: 10.1002/mrm.1910390610.
PubMed 9621916
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
- Functional MRI (fMRI) and Diffusion Tensor Imaging (DTI) in Temporal Lobe Epilepsy
- ClinicalTrials.gov ID
- NCT00081432
- Acronym / sponsor ID
- 040159
- Conditions
- Epilepsy, Temporal Lobe
- Keywords
- Seizures, Language, Memory, Brain, Imaging, Epilepsy, Temporal Lobe Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 9 Apr 2004
- Study completion
- 27 Apr 2010
- First posted
- 12 Apr 2004 (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 study uses functional magnetic resonance imaging (fMRI) and diffusion tensor imaging (DTI) to examine how the brain processes tasks involving language and emotion in normal volunteers and in patients with epilepsy. MRI is a diagnostic and research tool that uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The MRI scanner is a metal cylinder surrounded by a magnetic field. During the test, the subject lies on a table that can slide in and out of the cylinder. DTI involves taking pictures of the brain while the subject is at rest in order to learn about the structure of the brain. Information gained from this study will help scientists evaluate the organization of language and emotional functions in the brain.
Normal volunteers and patients with temporal lobe epilepsy 18 years of age and older who are native English speakers and who will undergo surgery for uncontrolled seizures may be eligible for this study. Candidates are initially screened by telephone, then with physical and neurologic examinations and cognitive testing.
The study has two parts, conducted 6 to 12 months apart. Each part consists of the same sets of tests described below, using fMRI and DTI. In patients with epilepsy, Part 1 is scheduled before surgery and Part 2 after surgery.
- fMRI: Subjects are asked to perform two types of tasks while they undergo fMRI. In one task, they are shown pictures of animals and tools and are asked to name them. In a second task, they are shown pictures that range in content from sexually explicit material, to human injury and surgical slides, to pleasant images of children and wildlife and are asked to decide whether they find the pictures pleasant, neutral, or unpleasant.
- DTI: Subjects relax and remain still in the MRI scanner for about 45 minutes.
- Neuropsychological testing: Subjects may be asked to complete questionnaires, take pen-and-paper or computerized tests, and perform motor tasks.
Participants may be asked to repeat the MRI studies, but not the neuropsychological tests, up to four times to investigate different brain functions or to confirm findings.
Detailed description
OBJECTIVES: Epilepsy surgery is emerging as a potent therapeutic intervention for a large group of patients with uncontrolled temporal lobe epilepsy, particularly when performed early in the course of the illness. Seizure freedom is an important goal of seizure surgery, but post-operative neuropsychological functioning is another equally important outcome measure. Both endpoints require careful pre-operative evaluation of the individual patient and better understanding of the functional neuroanatomy of the temporal lobe. In this study fMRI and DTI will be performed in patients with temporal lobe epilepsy and normal volunteers in an attempt to
- investigate the role of the anterior temporal cortex in semantic processing,
- evaluate the role of the amygdala in affective processing,
- correlate the extent of white matter pathway resection with cognitive outcome after temporal lobectomy.
STUDY POPULATION: We plan to study 30 patients with temporal lobe epilepsy (right-sided, left-sided seizure foci) pre and post temporal lobectomy as well as 30 normal volunteers.
DESIGN: The study will be done in two parts both consisting of identical tasks. For the patient group part 1 will be performed prior to temporal lobectomy and part 2, 6-12 months after temporal lobectomy. For the normal volunteer group parts 1 and 2 will be performed at time interval of 6-12 months.
During part 1 all study subjects will undergo neuropsychological evaluation. FMRI will be performed with two tasks: animal and tool naming (to evaluate semantic processing) and rating of emotionally pleasant or unpleasant pictures (to evaluate affective processing). All subjects will also undergo diffusion tensor imaging (DTI) for the visualization of white matter pathways.
During part 2 of the study all of the above tests will be repeated.
FMRI data will be analyzed within the framework of the general linear model in a program such as AFNI 2.5. Statistical comparisons between activation patterns in scans acquired during part 1 and part 2 within either group (intragroup comparison) will be done by voxel wise paired t-test. In a second analysis all 4 groups will be compared in a mixed model. The DTI data will be correlated with the neuropsychological outcome to asses the contribution of white matter abnormalities pre-operatively or severance of white matter pathways post-operative on neuropsychological functioning.
OUTCOME PARAMETERS: Outcome parameters are changes in the fMRI activation pattern post temporal lobectomy and disruption of anisotropy on the diffusion tensor images.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Temporal lobe epilepsy (right-sided, left-sided foci) with or without lesion on a structural MRI scan.
- Native English speaker.
- Age 18 years or older.
- Signed informed consent.
- Native English speaker.
Key exclusion criteria (12 listed)
- Medical or technical contraindications to MRI procedures (e.g. no braces, pacemakers, cochlear devices, surgical clips, etc;
- History of mental retardation;
- Pregnancy;
- Claustrophobia;
- Inability to comply with the protocol.
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 2 Jul 2017.
- Background: PubMed 1635805Barnes PD. Imaging of the central nervous system in pediatrics and adolescence. Pediatr Clin North Am. 1992 Aug;39(4):743-76. doi: 10.1016/s0031-3955(16)38374-2.
- Background: PubMed 11025519Basser PJ, Pajevic S, Pierpaoli C, Duda J, Aldroubi A. In vivo fiber tractography using DT-MRI data. Magn Reson Med. 2000 Oct;44(4):625-32. doi: 10.1002/1522-2594(200010)44:43.0.co;2-o.
- Background: PubMed 9621916Basser PJ, Pierpaoli C. A simplified method to measure the diffusion tensor from seven MR images. Magn Reson Med. 1998 Jun;39(6):928-34. doi: 10.1002/mrm.1910390610.
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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 Epilepsy and Temporal Lobe, 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 9 inclusion and 12 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 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 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 NCT00081432, 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.