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
| ISRCTN | ISRCTN43651633 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43651633 |
| Protocol serial number | Sonderforschungsbereich (SFB) TR3 subproject A1 |
| Sponsor | German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) |
| Funder | German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) |
- Submission date
- 30/09/2008
- Registration date
- 31/10/2008
- Last edited
- 31/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Klinik für Neurochirurgie
Sigmund-Freud-Str. 25
Bonn
53105
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, interventional, randomised single-centre study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Subtemporal versus transsylvian approach for selective amygdala-hippocampectomy: a randomised controlled trial on the epileptological and cognitive outcome |
| Study objectives | The aim of the study is to evaluate pre- and post-operative verbal episodic memory, frontal lobe executive functions and reward learning as a function of surgically-caused cortical lesions and dissections of fibre tracts from and to the temporal lobe structures. As the main surgical variation will be that of a preservation or dissection of the temporal stem, using a subtemporal versus a transsylvian approach, differences due to this variation are expected: 1. Preserving the temporal stem (subtemporal approach) results in a better crosstalk between frontal executive and temporal memory functions. Therefore memory aspects of organisation, differentiation, recognition (source memory) theoretically can be expected to be better preserved after the subtemporal approach as compared to the transsylvian approach. 2. Partial disconnection of the temporal stem (transsylvian approach) is possibly expected to result in a more pronounced effect of reward learning as the importance of the functional connection between temporal and frontal structures for this function has been discussed recently 3. The relevance of cognitive development and seizure control for quality of life and their implication for the patients' every day life are another topic of interest. How much memory decline will be accepted in favor of seizure freeness? With an unfavourable outcome in terms of seizure as well as memory outcome one might assume a negative impact on the patients' memory-dependent activities and their quality of life that might go along with higher rates of depression. |
| Ethics approval(s) | University of Bonn Medical Centre Ethics Committee approval received on the 30th April 2008 (ref: 032/08) |
| Health condition(s) or problem(s) studied | Intractable mesial temporal lobe epilepsy (MTLE) |
| Intervention | 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 either a subtemporal or a transsylvian surgical approach, resulting in a preservation (subtemporal approach) or dissection (transsylvian approach) of the temporal stem. 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(s) |
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: |
| Key secondary outcome measure(s) |
These address the question of the patients' quality of life, personality, depression and memory-dependent activities, which will be assessed using the following questionnaires: |
| Completion date | 30/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/10/2008 |
| Date of final enrolment | 30/06/2012 |
Locations
Countries of recruitment
- Germany
Study participating centre
53105
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |