Hippocampal SclerosisNCT06915649
Exploration and Evaluation of Amygdalo-Hippocampectomy According to Prof. Coubes' Technique: An Anatomical, Clinical, and Educational Approach
An observational study of Hippocampal Sclerosis and Dysembryoplastic Neuroepithelial Tumor, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The goal of this retrospective study is to evaluate the long-term clinical outcomes and complications associated with amygdalo-hippocampectomy using the surgical technique developed by Pr. Coubes (Montpellier, FRANCE). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hippocampal Sclerosis, Dysembryoplastic Neuroepithelial Tumor, Cortical Dysplasia
- What is being tested?
- Amygdalo-Hippocampectomy
- Type of treatment
- Surgery or procedure
- How many people
- 3,504 participants
- Where
- 1 siteFrance
- Study dates
- 31 Aug 2024to Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patients that have been followed in the University Hospital of Montpellier, France in the Epileptic Ward.
Who may be able to join
- Patients who had undergone an Amygdalo-Hippocampectomy according to the surgical procedure that we describe
Who cannot join
- Patients who did not have this exact procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Montpellier
Montpellier, Hérault, 34000
Pierre-Olivier MOSER, MD, +33 7 60 13 54 37, po-moser@chu-montpellier.fr
Gaetan POULEN, MD, PhD, +33 6 31 81 26 05, g-poulen@chu-montpellier.fr
About this study
The goal of this retrospective study is to evaluate the long-term clinical outcomes and complications associated with amygdalo-hippocampectomy using the surgical technique developed by Pr. Coubes (Montpellier, FRANCE). The main questions it aims to answer are:
- What are the complications and evolution of clinical outcomes in patients treated with this technique for hippocampal sclerosis or other intern temporal diseases ?
- What variables are associated with better seizure control following surgery?
Participants include 234 patients treated over the last 30 years at the CHU de Montpellier, FRANCE. The study will analyze clinical data, including seizure outcomes based on ILAE criteria, post-operative complications, and factors influencing recovery and reintegration into daily life.
Read the detailed description
Title Exploration and Evaluation of Amygdalo-Hippocampectomy Using Pr. Coubes' Technique: An Anatomical, Clinical, and Pedagogical Approach
Introduction The hippocampus, a vital component of the limbic system, plays a key role in memory and emotions. Unfortunately, it is also prone to various pathologies, such as hippocampal sclerosis, a condition characterized by progressive neuronal degeneration and subsequent fibrosis of the medial temporal lobe. Other diseases may occur such as tumours, Dysembryoplastic Neuroepithelial Tumour (DNET) or gliomas.
This condition often leads to severe symptoms, including pharmacoresistant epilepsy and memory disturbances that significantly impair the quality of life.
For patients with pharmacoresistant epilepsy associated with hippocampal sclerosis, surgery has emerged as a first-line therapeutic option. Among the surgical techniques, hippocampectomy and amygdalo-hippocampectomy aim to remove the affected portion of the hippocampus, reducing seizure propagation and improving patient outcomes. However, these procedures are marked by significant variability in their operative techniques, extents of resection, and patient selection criteria.
While the amygdalo-hippocampectomy technique described by Pr. Yasargil in 1985 remains a cornerstone in surgical approaches, other methods such as the trans-sylvian approach (Adada et al., 2008), the trans-gyral approach (Mathon \& Clemenceau, 2016), and emerging endoscopic techniques (H. Westley Phillips, 2023) highlight the diversity and evolution of surgical options.
This study seeks to explore in detail the surgical technique developed by Pr. Coubes, analyzing its anatomical, surgical, and clinical aspects. Additionally, it aims to compare this method with other surgical approaches to understand its benefits and limitations better in managing hippocampal sclerosis.
Objectives Primary Objective
- To describe the complications and the evolution of clinical outcomes in patients treated with Pr. Coubes' amygdalo-hippocampectomy technique.
Secondary Objective - To identify variables associated with favorable seizure control and overall clinical outcomes.
Study Design Type of Study
- Retrospective, single-center study conducted at the CHU de Montpellier.
Population
- 234 patients treated with this technique between 1980 and 2023, representing over three decades of clinical practice.
- Inclusion of both adult and pediatric patients.
Data Collection
- Retrospective extraction of clinical, imaging, and surgical data from patient records via the informatic patients' system.
- Data categories include demographic details, pre- and post-operative imaging (MRI), seizure frequency and type (ILAE criteria), complications, return-to-work rates, and social reintegration metrics.
Methodology Statistical Analysis
- Kaplan-Meier survival curves : Used to evaluate the time to the occurrence of complications or changes in clinical outcomes.
- Cox proportional hazards models : Conducted in both univariate and multivariate settings to identify predictors of post-operative outcomes and complications.
Outcome Measures
- Primary outcome : Seizure control evaluated using ILAE classification.
- Secondary outcomes : Post-operative complications, return-to-work rates, and functional reintegration.
Ethical Considerations
- Data Privacy : All patient data will be pseudonymized according to the French Ethic guidelines, with storage on secure CHU servers for a maximum of two years post-publication.
- Patient Notification : Informational letters will be sent to patients, detailing the study's objectives and their rights to non-opposition.
Expected Contributions
- Clinical Insights : Comprehensive analysis of over 30 years of surgical practice, offering robust data on the efficacy and safety of Pr. Coubes' technique.
- Comparative Perspective : Enhanced understanding of how this technique compares to other established and emerging surgical approaches.
- Pedagogical Value : Detailed anatomical and surgical documentation to guide future training and clinical practice in neurosurgery.
Conclusion This study represents a unique opportunity to document and analyze a long-practiced yet unpublished surgical technique. By consolidating decades of clinical experience and integrating advanced analytical methods, it aims to provide valuable insights for improving the management of hippocampal sclerosis, ultimately advancing patient care and surgical education.
- Conditions
- Hippocampal Sclerosis, Dysembryoplastic Neuroepithelial Tumor, Cortical Dysplasia, Ganglioglioma, Cavernoma, Epidermal Cyst
- Being tested
- Amygdalo-Hippocampectomy
- Keywords
- hippocampal sclerosis, hippocampectomy, amygdala-hippocampectomy, epilepsy surgery
- Medical subject headings
- Hippocampal Sclerosis, Malformations of Cortical Development, Ganglioglioma, Hemangioma, Capillary, Epidermal Cyst, Hamartoma, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amygdalo-HippocampectomyProcedure or surgery
This technique is characterized by specific hallmarks that distinguish it from other approaches, including the Yasargil technique and newer minimally invasive methods. It integrates precise anatomical targeting with optimized surgical pathways to enhance outcomes in patients with those pathologies. The approach of the choroidal fissure will be explained in the article.
By addressing limitations observed in traditional techniques, it aims to minimize neurological deficits while achieving better seizure control.
| Study group | Role | What they receive |
|---|---|---|
| Patients operated | We studied all the patients who underwent an Amygdalo-Hippocampectomy in the University Hospital of Montpellier, France from 1995 until 2022 Receives: Procedure: Amygdalo-Hippocampectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Surgical Classification assessing epilepsy's control
The ILAE post-surgical classification system is used to categorize seizure outcomes after epilepsy surgery. It provides a standardized way to evaluate how effectively surgery controls seizures, enabling consistency in reporting and comparison of surgical outcomes across studies and clinical settings.
In those cases of drug-resistance epilepsy, we will assess the epilepsy's control after the surgery.
- Completely seizure free; no auras
- Only auras; no other seizures
- One to three seizure days per year
- Four to 12 seizure days per year
- Daily seizures
- More than 100% increase of baseline ; auras
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to twenty years. The study starts in 2024 and ends in 2025, which lasts one year.
Secondary outcomes (5)
Post-operative complications : Infections
Each post-operative complications have been studied during the medical follow-up. It included the immediate post-operative complications such as presence of an infection.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to twenty years. The study starts in 2024 and ends in 2025, which lasts one year
Post-operative complications : Hematomas
Each post-operative complications have been studied during the medical follow-up. It included the immediate post-operative complications such as presence of hematoma.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to twenty years. The study starts in 2024 and ends in 2025, which lasts one year.
Post-operative way of life
As part of this research on the surgery, the investigators are studying the post-surgical way of life of patients who have undergone this procedure. This includes evaluating various aspects of their daily functioning, such as autonomy, cognitive and psychiatric outcomes, social integration, and overall quality of life. By analyzing these factors, the investigators aim to better understand the long-term impact of hippocampectomy and identify potential areas for improving patient care and rehabilitation strategies.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to twenty years. The study starts in 2024 and ends in 2025, which lasts one year.
Risk factors or predisposing factors of success or failure after Amygdalo-Hippocampectomy
Among the patients who underwent favourable and unfavourable evolutions, we will assess the risk factors and the predisposing factors such as febrile seizure, medical history, etiologic lesions.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to twenty years
Anti-Seizures Medications (ASM) evolution after the surgery
The investigators have also compared the potential evolution of the medications after the surgery given the drug-resistance profil of these patients.
The number of tablets have been reported before the surgery and at the last medical follow-up.
Measured: Medication prescribed before the surgery and medication prescribed at the last medical follow-up, assessed up to twenty years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start31 Aug 2024
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hippocampal SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaetan POULEN, MD, PhD, Study director, CHU de MONTPELLIER, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915649
- Sponsor's protocol ID
- 2024-08-115
- Status last verified
- Apr 2025
- First submitted
- 16 Jan 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration and Evaluation of Amygdalo-Hippocampectomy According to Prof. Coubes' Technique: An Anatomical, Clinical, and Educational Approach
- ClinicalTrials.gov ID
- NCT06915649
- Acronym / sponsor ID
- 2024-08-115
- Conditions
- Hippocampal Sclerosis, Dysembryoplastic Neuroepithelial Tumor, Cortical Dysplasia, Ganglioglioma, Cavernoma, Epidermal Cyst
- Keywords
- hippocampal sclerosis, hippocampectomy, amygdala-hippocampectomy, epilepsy surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,504 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 31 Aug 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this retrospective study is to evaluate the long-term clinical outcomes and complications associated with amygdalo-hippocampectomy using the surgical technique developed by Pr. Coubes (Montpellier, FRANCE). The main questions it aims to answer are:
- What are the complications and evolution of clinical outcomes in patients treated with this technique for hippocampal sclerosis or other intern temporal diseases ?
- What variables are associated with better seizure control following surgery?
Participants include 234 patients treated over the last 30 years at the CHU de Montpellier, FRANCE. The study will analyze clinical data, including seizure outcomes based on ILAE criteria, post-operative complications, and factors influencing recovery and reintegration into daily life.
Detailed description
Title Exploration and Evaluation of Amygdalo-Hippocampectomy Using Pr. Coubes' Technique: An Anatomical, Clinical, and Pedagogical Approach
Introduction The hippocampus, a vital component of the limbic system, plays a key role in memory and emotions. Unfortunately, it is also prone to various pathologies, such as hippocampal sclerosis, a condition characterized by progressive neuronal degeneration and subsequent fibrosis of the medial temporal lobe. Other diseases may occur such as tumours, Dysembryoplastic Neuroepithelial Tumour (DNET) or gliomas.
This condition often leads to severe symptoms, including pharmacoresistant epilepsy and memory disturbances that significantly impair the quality of life.
For patients with pharmacoresistant epilepsy associated with hippocampal sclerosis, surgery has emerged as a first-line therapeutic option. Among the surgical techniques, hippocampectomy and amygdalo-hippocampectomy aim to remove the affected portion of the hippocampus, reducing seizure propagation and improving patient outcomes. However, these procedures are marked by significant variability in their operative techniques, extents of resection, and patient selection criteria.
While the amygdalo-hippocampectomy technique described by Pr. Yasargil in 1985 remains a cornerstone in surgical approaches, other methods such as the trans-sylvian approach (Adada et al., 2008), the trans-gyral approach (Mathon \& Clemenceau, 2016), and emerging endoscopic techniques (H. Westley Phillips, 2023) highlight the diversity and evolution of surgical options.
This study seeks to explore in detail the surgical technique developed by Pr. Coubes, analyzing its anatomical, surgical, and clinical aspects. Additionally, it aims to compare this method with other surgical approaches to understand its benefits and limitations better in managing hippocampal sclerosis.
Objectives Primary Objective
- To describe the complications and the evolution of clinical outcomes in patients treated with Pr. Coubes' amygdalo-hippocampectomy technique.
Secondary Objective - To identify variables associated with favorable seizure control and overall clinical outcomes.
Study Design Type of Study
- Retrospective, single-center study conducted at the CHU de Montpellier.
Population
- 234 patients treated with this technique between 1980 and 2023, representing over three decades of clinical practice.
- Inclusion of both adult and pediatric patients.
Data Collection
- Retrospective extraction of clinical, imaging, and surgical data from patient records via the informatic patients' system.
- Data categories include demographic details, pre- and post-operative imaging (MRI), seizure frequency and type (ILAE criteria), complications, return-to-work rates, and social reintegration metrics.
Methodology Statistical Analysis
- Kaplan-Meier survival curves : Used to evaluate the time to the occurrence of complications or changes in clinical outcomes.
- Cox proportional hazards models : Conducted in both univariate and multivariate settings to identify predictors of post-operative outcomes and complications.
Outcome Measures
- Primary outcome : Seizure control evaluated using ILAE classification.
- Secondary outcomes : Post-operative complications, return-to-work rates, and functional reintegration.
Ethical Considerations
- Data Privacy : All patient data will be pseudonymized according to the French Ethic guidelines, with storage on secure CHU servers for a maximum of two years post-publication.
- Patient Notification : Informational letters will be sent to patients, detailing the study's objectives and their rights to non-opposition.
Expected Contributions
- Clinical Insights : Comprehensive analysis of over 30 years of surgical practice, offering robust data on the efficacy and safety of Pr. Coubes' technique.
- Comparative Perspective : Enhanced understanding of how this technique compares to other established and emerging surgical approaches.
- Pedagogical Value : Detailed anatomical and surgical documentation to guide future training and clinical practice in neurosurgery.
Conclusion This study represents a unique opportunity to document and analyze a long-practiced yet unpublished surgical technique. By consolidating decades of clinical experience and integrating advanced analytical methods, it aims to provide valuable insights for improving the management of hippocampal sclerosis, ultimately advancing patient care and surgical education.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients operated | – | Procedure: Amygdalo-HippocampectomyWe studied all the patients who underwent an Amygdalo-Hippocampectomy in the University Hospital of Montpellier, France from 1995 until 2022 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients that have been followed in the University Hospital of Montpellier, France in the Epileptic Ward.
Key inclusion criteria (1 listed)
- Patients who had undergone an Amygdalo-Hippocampectomy according to the surgical procedure that we describe
Key exclusion criteria (1 listed)
- Patients who did not have this exact procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amygdalo-HippocampectomyThis technique is characterized by specific hallmarks that distinguish it from other approaches, including the Yasargil technique and newer minimally invasive methods. It integrates precise anatomical targeting with optimized surgical pathways to enhance outcomes in patients with those pathologies. The approach of the choroidal fissure will be explained in the article. By addressing limitations observed in traditional techniques, it aims to minimize neurological deficits while achieving better seizure control. | Procedure or surgery | Patients operated |
Primary outcome
Post-Surgical Classification assessing epilepsy's control
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to twenty years. The study starts in 2024 and ends in 2025, which lasts one year.
The ILAE post-surgical classification system is used to categorize seizure outcomes after epilepsy surgery. It provides a standardized way to evaluate how effectively surgery controls seizures, enabling consistency in reporting and comparison of surgical outcomes across studies and clinical settings. In those cases of drug-resistance epilepsy, we will assess the epilepsy's control after the surgery. 1. Completely seizure free; no auras 2. Only auras; no other seizures 3. One to three seizure days per year 4. Four to 12 seizure days per year 5. Daily seizures 6. More than 100% increase of baseline ; auras
5 secondary outcomes
Post-operative complications : Infections
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to twenty years. The study starts in 2024 and ends in 2025, which lasts one year
Post-operative complications : Hematomas
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to twenty years. The study starts in 2024 and ends in 2025, which lasts one year.
Post-operative way of life
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to twenty years. The study starts in 2024 and ends in 2025, which lasts one year.
Risk factors or predisposing factors of success or failure after Amygdalo-Hippocampectomy
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to twenty years
Anti-Seizures Medications (ASM) evolution after the surgery
Time frame: Medication prescribed before the surgery and medication prescribed at the last medical follow-up, assessed up to twenty years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
Related trials for Hippocampal Sclerosis
RecruitingPhase 1/2
AMT-260 Gene Therapy Study in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy
Mesial Temporal Lobe Epilepsy
Active, not recruitingObservational study
Gene Expression Changes of Brain Tissue in Human Temporal Lobe Epilepsy With Hippocampal Sclerosis
Epilepsy, Hippocampal Sclerosis
Active, not recruitingPhase 2
Safety and Modulation of ABCC9 Pathways by Nicorandil for the Treatment of Hippocampal Sclerosis of Aging
Dementia, Mild Cognitive Impairment
Active, not recruiting
Subiculum Electrical Stimulation for Temporal Lobe Epilepsy With Biliteral Hippocampus Sclerosis(SESTB)
Epilepsy, Drug Resistant
Not yet recruiting
Piriform Cortex Electrical Stimulation for Temporal Lobe Epilepsy With Biliteral Hippocampus Sclerosis
Epilepsy, Drug Resistant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gaetan POULEN, MD, PhD study director
CHU de MONTPELLIER, FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hippocampal Sclerosis and Dysembryoplastic Neuroepithelial Tumor, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre-Olivier MOSER, Medical Doctor (+33 7 60 13 54 37, po-moser@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Surgical Classification assessing epilepsy's control (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to twenty years. The study starts in 2024 and ends in 2025, which lasts one year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.