Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-31 @ 12:56 AM
Study NCT ID:
NCT00081432
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Language and Emotional Function in Patients With Temporal Lobe Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D012640', 'term': 'Seizures'}, {'id': 'D007802', 'term': 'Language'}, {'id': 'D004833', 'term': 'Epilepsy, Temporal Lobe'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D004828', 'term': 'Epilepsies, Partial'}, {'id': 'D000073376', 'term': 'Epileptic Syndromes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04-27', 'completionDateStruct': {'date': '2010-04-27'}, 'lastUpdateSubmitDate': '2017-06-30', 'studyFirstSubmitDate': '2004-04-10', 'studyFirstSubmitQcDate': '2004-04-09', 'lastUpdatePostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-04-12', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Seizures', 'Language', 'Memory', 'Brain', 'Imaging', 'Epilepsy', 'Temporal Lobe Epilepsy'], 'conditions': ['Epilepsy', 'Temporal Lobe']}, 'referencesModule': {'references': [{'pmid': '1635805', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11025519', 'type': 'BACKGROUND', 'citation': 'Basser 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.'}, {'pmid': '9621916', 'type': 'BACKGROUND', 'citation': 'Basser 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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nNormal 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.\n\nThe 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.\n\n* 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.\n* DTI: Subjects relax and remain still in the MRI scanner for about 45 minutes.\n* Neuropsychological testing: Subjects may be asked to complete questionnaires, take pen-and-paper or computerized tests, and perform motor tasks.\n\nParticipants 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.', 'detailedDescription': '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\n\n1. investigate the role of the anterior temporal cortex in semantic processing,\n2. evaluate the role of the amygdala in affective processing,\n3. correlate the extent of white matter pathway resection with cognitive outcome after temporal lobectomy.\n\nSTUDY 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.\n\nDESIGN: 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.\n\nDuring 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.\n\nDuring part 2 of the study all of the above tests will be repeated.\n\nFMRI 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.\n\nOUTCOME PARAMETERS: Outcome parameters are changes in the fMRI activation pattern post temporal lobectomy and disruption of anisotropy on the diffusion tensor images.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nPatient Group:\n\nTemporal lobe epilepsy (right-sided, left-sided foci) with or without lesion on a structural MRI scan.\n\nNative English speaker.\n\nAge 18 years or older.\n\nSigned informed consent.\n\nVolunteer Group:\n\nNative English speaker.\n\nAge 18 years or older.\n\nSigned informed consent.\n\nEXCLUSION CRITERIA:\n\nPatient Group:\n\nMedical or technical contraindications to MRI procedures (e.g. no braces, pacemakers, cochlear devices, surgical clips, etc;\n\nHistory of mental retardation;\n\nPregnancy;\n\nClaustrophobia;\n\nInability to comply with the protocol.\n\nVolunteer Group:\n\nMedical or technical contraindications to MRI procedures (e.g. no braces, pacemakers, cochlear devices, surgical clips, etc.);\n\nHistory of neurologic or psychiatric disease or a learning or attention disorder or mental retardation.\n\nPregnancy.\n\nClaustrophobia.\n\nInability to comply with the protocol.'}, 'identificationModule': {'nctId': 'NCT00081432', 'briefTitle': 'Language and Emotional Function in Patients With Temporal Lobe Epilepsy', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Functional MRI (fMRI) and Diffusion Tensor Imaging (DTI) in Temporal Lobe Epilepsy', 'orgStudyIdInfo': {'id': '040159'}, 'secondaryIdInfos': [{'id': '04-N-0159'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center, 9000 Rockville Pike', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}}}}