Evaluation of neurosurgical resection strategies in temporal lobe epilepsy

ISRCTN	ISRCTN50562632
DOI	https://doi.org/10.1186/ISRCTN50562632
Secondary identifying numbers	N/A

Submission date: 11/08/2008
Registration date: 21/08/2008
Last edited: 28/08/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Johannes Schramm
Scientific

Sigmund-Freud-Str. 25
Bonn
53105
Germany

Study information

Study design	Prospective, interventional, randomised multicentre study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Patient information can be found at: http://www.ukb.intern/42256BC8002AF3E7/vwWebPagesByID/8BE510569EF540CCC12571D40056E8CD
Scientific title	Prospective and randomised multicentre trial investigating the pros and cons of different extent of mesial resection in surgery for mesial temporal lobe epilepsy
Study objectives	There is an ongoing debate about the mesial resection extent in the surgical treatment of temporal lobe (TL) epilepsy patients and its relation to seizure freedom and neuropsychological outcome. Surgical resection strategies developed from larger resections removing up to 2/3 of the temporal lobe to more selective and smaller resection types. The objective of this study is to assess the significance of the extent of resection of mesial structures (hippocampus and parahippocampus) to achieve seizure freedom after surgery for temporal lobe epilepsy. The main goals of this project are to test two hypotheses: 1. Smaller TL resections are associated with less neuropsychological deterioration 2. Post-operative seizure freedom is comparably good in smaller mesial resection
Ethics approval(s)	Ethics approval received from the Ethics Committee of the University of Bonn Medical Centre on the 2nd February 2001 (ref: 237/00)
Health condition(s) or problem(s) studied	Intractable mesial temporal lobe epilepsy (MTLE)
Intervention	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 the cognitive abilities of the patients. Patients were randomised to either a short (2.5 cm of hippocampal resection) or a long (3.5 resection length) resection group. The length of resection was to be determined intra-operatively after the opening of the temporal horn by using millimetre paper from the anterior tip of the temporal horn backwards placed on the hippocampal head along its length axis. Furthermore, manual volumetry of structural MRI datasets was used to evaluate the intended resection length. Post-operatively, patients are seen for MRI-scanning, neuropsychological testing and medical consultation 3, 6 and 12 months after surgery.
Intervention type	Other
Primary outcome measure	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 outcome measures	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 unpublished German CNS-disease related personality questionnaire 7.3. Quality of Life Inventory in Epilepsy, 10-item version (QOLI-10) All neuropsychological results were classified into five categories (0 = noticeably abnormal, 1 = moderately abnormal, 2 = borderline, 3 = without pathological findings, 4 = above average).
Overall study start date	15/10/2002
Completion date	30/06/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	200 to 250
Key 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
Key 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)
Date of first enrolment	15/10/2002
Date of final enrolment	30/06/2008

Locations

Countries of recruitment

Germany

Study participating centre

Sigmund-Freud-Str. 25

Bonn
53105
Germany

Sponsor information

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
Research council

Kennedyallee 40
Bonn
53175
Germany

Website	http://www.dfg.de/
"ROR"	https://ror.org/018mejw64

Funders

Funder type

Research council

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	Cortical damage results ():	01/02/2004	Yes	No
Results article	Neuropsychological outcome results ():	01/07/2004	Yes	No
Results article	One year follow-up results ():	01/08/2004	Yes	No
Results article	Children and aduly comparative study results ():	01/12/2005	Yes	No
Results article	MRI volumetry results ():	01/03/2007	Yes	No
Other publications	Research ():	01/12/2007	Yes	No
Results article	Memory and non-memory function results ():	01/01/2008	Yes	No
Other publications	Comment ():	01/02/2008	Yes	No
Results article	Cognitive rehabilitation results ():	01/04/2008	Yes	No
Other publications	Review ():	01/08/2008	Yes	No
Results article	Prospective study results ():	01/08/2008	Yes	No