Randomised controlled trial on the impact of collateral damage and disconnections on memory outcome after temporal lobe epilepsy surgery and the relevance of surgically caused memory decline for every day activities and functioning

Subtemporal versus transsylvian approach for selective amygdala-hippocampectomy: a randomised controlled trial on the epileptological and cognitive outcome

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN43651633

Enrollment

Registered

2008-10-31

Start date

2008-10-15

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 pre-surgical evaluation patients and healthy controls will be neuropsychologically tested and investigated with functional as well as structural MRI. Patients were then randomised to ei

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Both males and females 2. Patients suffering from intractable temporal lobe epilepsy 3. Drug resistance 4. Presurgical evaluation led to the recommendation of selective amygdalo-hippocampectomy (SAH) 4. Only cases with an magnetic resonance imaging (MRI)-based diagnosis of Ammon's horn sclerosis will be included 5. Adults (greater than 18 years) 6. Patients have to be able to understand the study plan and give written informed consent

Exclusion criteria

Exclusion criteria: 1. Previous temporal lobe surgery 2. Inability to undergo neuropsychological testing because of retardation or insufficient German language skills 3. Gravidity 4. Claustrophobia 5. Metallic implants/non-removable piercings 6. Neurological/psychiatric illness

Design outcomes

Primary

Measure	Time frame
Neuropsychological outcome in memory and non-memory functions as well as in brain activation in three fMRI paradigms will serve as dependent measures. Each patient will undergo comprehensive neuropsychological testing pre-operatively and 12 months post-operatively. The following tests will be applied: 1. Verbal learning and memory: two parallel versions of a pre- and post-operative Verbal Learning Test (VLMT- Verbaler Lern- und Merkfähigkeitstest). 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. FMRI investigation: a new fMRI paradigm will be established for reward learning All respective measures (primary and secondary outcome measures	—

Measure

Time frame

Neuropsychological outcome in memory and non-memory functions as well as in brain activation in three fMRI paradigms will serve as dependent measures. Each patient will undergo comprehensive neuropsychological testing pre-operatively and 12 months post-operatively. The following tests will be applied: 1. Verbal learning and memory: two parallel versions of a pre- and post-operative Verbal Learning Test (VLMT- Verbaler Lern- und Merkfähigkeitstest). 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. FMRI investigation: a new fMRI paradigm will be established for reward learning All respective measures (primary and secondary outcome measures

—

Secondary

Measure	Time frame
These address the question of the patients' quality of life, personality, depression and memory-dependent activities, which will be assessed using the following questionnaires: 1. A German version of the Beck Depression Inventory (BDI) 2. FPZ (Fragebogen zur Persönlichkeit bei zerebralen Erkrankungen), an unpublished German CNS-disease related personality questionnaire 3. A German adaptation of the QOLIE-10 (Quality of Life Inventory in Epilepsy, 10-Item version), a brief questionnaire to screen for quality of life in epilepsy 4. "Memory activities in every day life" MADL, a questionnaire on frequencies of memory dependent everyday activities. The MADL, is a new, unpublished rating scale which has been developed as part of a workshop of the International League against Epilepsy in Venice and is intended to fill the gap between neuropsychological memory impairment, subjective opinion and memory in every day life. All respective measures (primary and secondary outcome measures) will be obtained pre-operatively and 12 months post-operatively.	—

Measure

Time frame

These address the question of the patients' quality of life, personality, depression and memory-dependent activities, which will be assessed using the following questionnaires: 1. A German version of the Beck Depression Inventory (BDI) 2. FPZ (Fragebogen zur Persönlichkeit bei zerebralen Erkrankungen), an unpublished German CNS-disease related personality questionnaire 3. A German adaptation of the QOLIE-10 (Quality of Life Inventory in Epilepsy, 10-Item version), a brief questionnaire to screen for quality of life in epilepsy 4. "Memory activities in every day life" MADL, a questionnaire on frequencies of memory dependent everyday activities. The MADL, is a new, unpublished rating scale which has been developed as part of a workshop of the International League against Epilepsy in Venice and is intended to fill the gap between neuropsychological memory impairment, subjective opinion and memory in every day life. All respective measures (primary and secondary outcome measures) will be obtained pre-operatively and 12 months post-operatively.

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Countries

Germany

Outcome results

None listed

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