Clinical trial NCT03643471: Advanced Magnetic Resonance Imaging in Temporal Lobe Epilepsy
Official title: Role of Advanced Magnetic Resonance Imaging in Diagnosis of Idiopathic Temporal Lobe Epilepsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Temporal Lobe Epilepsy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Patients with history of partial seizures with or without secondary generalization attending at outpatient clinic or admitted at Neurology department of Assuit University Hospital with clinical features consistent with seizures of temporal lobe origin, Focal ictal temporal lobe patterns recorded with EEG and no lesion detected by conventional MR imaging other than mesial temporal sclerosis.

Brief summary: We aim to o evaluate the role of conventional and advanced MRI sequences in diagnosis of idiopathic temporal lobe epilepsy including identification and lateralization of epileptogenic focus.

Detailed description: Patients with history of partial seizures with or without secondary generalization attending at outpatient clinic or admitted at Neurology department of Assuit University Hospital will be included in the study MRI study will be done for each patient. MR imaging will be performed on a 1.5-T MR imaging unit (Siemens, Sembra medical system,German).

Prospectively completed data forms will be analyzed and compared. Statistical tests appropriate to the nature of the data will be used.

All patients will not be subjected to risk of any kind during this study. All patients' data will be confidentially kept. Approval of the ethical committee of Faculty of Medicine, Assiut University.

An informed consent will be taken from all patients included in this study. The research will be conducted only by scientifically qualified and trained personnel.

The procedures included in this study have been already used in hospital and centers in and outside Egypt

Eligibility criteria: Inclusion Criteria:

* patients with history of partial seizures with or without secondary generalization attending at outpatient clinic or admitted at Neurology department of Assuit University Hospital will be included in the study based on the following criteria:

  * Clinical features consistent with seizures of temporal lobe origin.
  * Focal ictal temporal lobe patterns recorded with EEG.
  * No lesion detected by conventional MR imaging other than mesial temporal sclerosis.

Exclusion Criteria:

* Any general contraindication of MRI in some cases as presence of para magnetic substance as pacemakers or in patients with claustrophobia.
* Subjects with age less than 12 year old.
* Patients with any structural lesion other than mesial temporal sclerosis identified on MR brain imaging.

Primary outcomes:
measure: Calculating the sensitivity,specificity and accuracy of hippocampal volumetry , T2 relaxometry , MR spectroscopy and diffusion tensor imaging in identification and lataeralization of epileptogenic focus
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
References:
citation: Muhlhofer W, Tan YL, Mueller SG, Knowlton R. MRI-negative temporal lobe epilepsy-What do we know? Epilepsia. 2017 May;58(5):727-742. doi: 10.1111/epi.13699. Epub 2017 Mar 7.
citation: Crocker CE, Pohlmann-Eden B, Schmidt MH. Role of neuroimaging in first seizure diagnosis. Seizure. 2017 Jul;49:74-78. doi: 10.1016/j.seizure.2016.05.015. Epub 2016 Jun 1.
citation: Ruber T, David B, Elger CE. MRI in epilepsy: clinical standard and evolution. Curr Opin Neurol. 2018 Apr;31(2):223-231. doi: 10.1097/WCO.0000000000000539.
citation: Chinchure S, Kesavadas C, Thomas B. Structural and functional neuroimaging in intractable epilepsy. Neurol India. 2010 May-Jun;58(3):361-70. doi: 10.4103/0028-3886.65569.