NCT03643471

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

January 22, 2019

Status Verified

January 1, 2019

Enrollment Period

8 months

First QC Date

August 21, 2018

Last Update Submit

January 18, 2019

Conditions

Temporal Lobe Epilepsy

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

MRIDEVICE

Magnetic resonance imaging with advanced sequences including volumetry, spectroscopy and tractograpghy.

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospital

Asyut, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 28266710BACKGROUND

  • 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.

    PMID: 27324840BACKGROUND

  • 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.

    PMID: 29389747BACKGROUND

  • 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.

    PMID: 20644262BACKGROUND

MeSH Terms

Conditions

Epilepsy, Temporal Lobe

Condition Hierarchy (Ancestors)

Epilepsies, PartialEpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic Syndromes

Central Study Contacts

Radwa Anas, Master

CONTACT

+201028820029radwaanas@yahoo.com

Osama Haris, doctorate

CONTACT

medicine_22@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 22, 2018

Study Start

January 1, 2019

Primary Completion

September 1, 2019

Study Completion

December 30, 2019

Last Updated

January 22, 2019

Record last verified: 2019-01

Locations

EG(1)