Advanced Magnetic Resonance Imaging in Temporal Lobe Epilepsy

Temporal Lobe Epilepsy Clinical Trial

Official title:

Role of Advanced Magnetic Resonance Imaging in Diagnosis of Idiopathic Temporal Lobe Epilepsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03643471
• Other study ID #: MRI in temporal lobe epilepsy
• Status: Recruiting
• Start date: January 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2019
• Source: Assiut University
• Contact: Radwa Anas, Master
• Phone: +201028820029
• Email: radwaanas[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Temporal Lobe
• Temporal Lobe Epilepsy

Intervention

Device:
• MRI
Magnetic resonance imaging with advanced sequences including volumetry, spectroscopy and tractograpghy.

Locations

Country	Name	City	State
Egypt	Assiut university hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. Review. — View 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. Review. — View 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. Review. — View Citation

Rüber 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculating the sensitivity,specificity and accuracy of hippocampal volumetry , T2 relaxometry , MR spectroscopy and diffusion tensor imaging in identification and lataeralization of epileptogenic focus	Quantification of hippocampal volumes bilaterally by mean of hippocampal volumetry; Change in metabolites ratio at the affected hippocampus by mean of MR spectroscopy	baseline