Evaluation of neurosurgical resection strategies in temporal lobe epilepsy

Prospective and randomised multicentre trial investigating the pros and cons of different extent of mesial resection in surgery for mesial temporal lobe epilepsy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN50562632

Enrollment

250

Registered

2008-08-21

Start date

2002-10-15

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intractable mesial temporal lobe epilepsy (MTLE) Nervous System Diseases Epilepsy

Interventions

As part of the presurgical evaluation patients underwent neuropsychological testing and MRI scanning. Healthy volunteers also underwent neuropsychological testing to serve as a control group regarding

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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: 1. Engel class I: seizure-free 2. Engel class II: almost seizure-free 3. Engel class III: significant seizure reduction 4. Engel class IV: no significant improvement 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. Secondary analysis: Seizure freeness in subgroups (based on neuropathological analyses), e.g. patients with mesial temporal sclerosis.	—

Measure

Time frame

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: 1. Engel class I: seizure-free 2. Engel class II: almost seizure-free 3. Engel class III: significant seizure reduction 4. Engel class IV: no significant improvement 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. Secondary analysis: Seizure freeness in subgroups (based on neuropathological analyses), e.g. patients with mesial temporal sclerosis.

—

Secondary

Measure	Time frame
Neuropsychological testing: Each patient underwent comprehensive neuropsychological testing pre-operatively and 12-months post-operatively. For the comprehensive purpose of this study, various neuropsychological parameters are aggregated, resulting in scores for seven major cognitive domains: 1. Verbal learning and memory: two parallel versions of a pre- and post-operative verbal learning test (Verbaler Lern- und Merkfähigkeitstest [VLMT]). The VLMT (German adaptation of the Rey Auditory Verbal Learning Test) requires five trials of learning and recall of a word list consisting of 15 words, free recall immediately after distraction (learning/recall of a second list in one trial) and a recall after a half-hour delay, which is followed by a recognition trial (list with original words plus distractors). 2. Figural learning and memory was obtained using the DCS-R, a German revised version of the DCS, a design list learning test (Diagnostikum für Zerebralschädigung) 3. Language functions: 3.1. Confrontation naming, Boston Naming Test 3.2. Phonematic and semantic fluency 3.3. Token Test, a subtest of the Aachener Aphasie-Test (a german test battery for aphasia) which is seen to measure verbal comprehension 4. Attention functions: 4.1. D2-Test, a letter cancellation test 4.2. The c.I.T., a short test to measure cerebral insufficiency (Kurztest für cerebrale Insuffizienz) 5. Psychomotor speed, mental tracking and cognitive flexibility: 5.1. Trail Making Test A and B (TMT-A/B) 5.2. Motoric sequences after Lurija 5.3. Purdue Pegboard 5.4. Finger Tapping Test 6. Visual and spatial abilities: 6.1. Subtest LPS-7 of the Leistungsprüfsystem (LPS), a german intelligence battery 6.2. The Mosaic-Test, a subtest of the German version of the Wechsler Adult Intelligence Scale-Revised (HAWIE-R) 6.3. Labyrinth test 7. Behaviour and personality features: 7.1. German version of the Beck Depression Inventory (BDI) 7.2. FPZ (Fragebogen zur Persönlichkeit bei zerebralen Erkrankungen), an	—

Measure

Time frame

Neuropsychological testing: Each patient underwent comprehensive neuropsychological testing pre-operatively and 12-months post-operatively. For the comprehensive purpose of this study, various neuropsychological parameters are aggregated, resulting in scores for seven major cognitive domains: 1. Verbal learning and memory: two parallel versions of a pre- and post-operative verbal learning test (Verbaler Lern- und Merkfähigkeitstest [VLMT]). The VLMT (German adaptation of the Rey Auditory Verbal Learning Test) requires five trials of learning and recall of a word list consisting of 15 words, free recall immediately after distraction (learning/recall of a second list in one trial) and a recall after a half-hour delay, which is followed by a recognition trial (list with original words plus distractors). 2. Figural learning and memory was obtained using the DCS-R, a German revised version of the DCS, a design list learning test (Diagnostikum für Zerebralschädigung) 3. Language functions: 3.1. Confrontation naming, Boston Naming Test 3.2. Phonematic and semantic fluency 3.3. Token Test, a subtest of the Aachener Aphasie-Test (a german test battery for aphasia) which is seen to measure verbal comprehension 4. Attention functions: 4.1. D2-Test, a letter cancellation test 4.2. The c.I.T., a short test to measure cerebral insufficiency (Kurztest für cerebrale Insuffizienz) 5. Psychomotor speed, mental tracking and cognitive flexibility: 5.1. Trail Making Test A and B (TMT-A/B) 5.2. Motoric sequences after Lurija 5.3. Purdue Pegboard 5.4. Finger Tapping Test 6. Visual and spatial abilities: 6.1. Subtest LPS-7 of the Leistungsprüfsystem (LPS), a german intelligence battery 6.2. The Mosaic-Test, a subtest of the German version of the Wechsler Adult Intelligence Scale-Revised (HAWIE-R) 6.3. Labyrinth test 7. Behaviour and personality features: 7.1. German version of the Beck Depression Inventory (BDI) 7.2. FPZ (Fragebogen zur Persönlichkeit bei zerebralen Erkrankungen), an

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026