Evaluation of neurosurgical resection strategies in temporal lobe epilepsy

Completed

• Conditions: Intractable mesial temporal lobe epilepsy (MTLE); Nervous System Diseases; Epilepsy

• Registration Number: ISRCTN50562632
• Lead Sponsor: German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-21
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Patients suffering from intractable temporal lobe epilepsy
2. Drug resistance: seizure history lasting more than two years
3. Pre-surgical evaluation led to the recommendation of either a partial temporal lobe resection combined with amygdalohippocampectomy or a more restricted selected selective amygdalohippocampectomy (SAH)
4. Only cases with mesial involvement were included
5. Patients had to be at least 18 years old (either sex) and able to understand the study plan
6. Written informed consent

Exclusion Criteria

1. Previous temporal lobe surgery
2. Inability to do undergo neuropsychological testing because of retardation or foreign language
3. Mesial resection restricted to uncus and amygdala
4. No usable pre-operative magnetic resonance imaging (MRI) for volumetrical analyses
5. Pathology not allowing for randomisation (far dorsal reaching resection necessary)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Seizure freedom at one year after surgery: defined as class I in the Engel Outcome Scale. The Engel Outcome Scale is administered post-operatively and determines the improvement/worsening after surgical intervention as follows:<br>1. Engel class I: seizure-free<br>2. Engel class II: almost seizure-free<br>3. Engel class III: significant seizure reduction<br>4. Engel class IV: no significant improvement<br><br>Patients belonging to Engel class I are termed as seizure free, the remaining patients (Engel II - IV) as non-seizure free patients in the present study.<br><br>Secondary analysis:<br>Seizure freeness in subgroups (based on neuropathological analyses), e.g. patients with mesial temporal sclerosis.