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The primary objective of this research is to study the efficacy and safety of Stereotactic EEG (SEEG) guided radio-frequency thermocoagulation (RF-TC) of Subiculum as adjunctive therapy for reducing the frequency of seizures in drug-resistant temporal lobe epilepsy with Mesial temporal lobe epilepsy with hippocampal sclerosis (mTLE-HS).
Mesial temporal lobe epilepsy (mTLE) is the most classical subtype of temporal lobe epilepsy, which is the indication of surgical intervention after evaluation. This project aims to include 20 participants, and evaluate the effectiveness and safety of Stereotactic EEG (SEEG) guided radio-frequency thermocoagulation (RF-TC) of Subiculum in patients with mesial temporal lobe epilepsy with hippocampal sclerosis through A prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with mTLE-HS with alternative treatment options.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subiculum RF-TC group | Experimental | SEEG recording and Subiculum RF-TC minimal invasive treatment for mTLE-HS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subiculum RF-TC | Procedure | SEEG implantation after evaluation, record the interictal and ictal EEG, and perform Subiculum RF-TC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seizure frequency (SF28) | Seizure frequency (SF28) is defined as seizure count per month (28-day) period. The SF28 is calculated as follows, where D=total number of days for which seizure information is collected for the specific 28-day interval: SF28=(Total number of seizures in D days/D)*28. In addition, the baseline seizure frequency is defined as mean of 3-month SF28 in the baseline period. The seizure frequency in double-blind phase is defined as SF28 per month during the double-blind period. Percent change in seizure frequency=100*(double-blind SF28-baseline SF28)/baseline SF28. | Up to 1 year after subculum-SEEG Guided RF-TC |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure Responder Rate | The proportion of patients with a ≥ 50% reduction from Baseline in seizure frequency. | Up to 1 year after subculum-SEEG Guided RF-TC |
| Life quality evaluation | Percentage change from baseline in Quality of Life in Epilepsy-31 inventory (QOLIE-31) score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liankun Ren | Contact | +86 13681576621 | renlk2022@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Liankun Ren, MD | Xuanwu Hospital, Beijing | Principal Investigator |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Up to 1 year after subculum-SEEG Guided RF-TC |
| Cognitive function evaluation (MMSE) | Percentage change from baseline in Mini-Mental State Examination (MMSE) score. | Up to 1 year after subculum-SEEG Guided RF-TC |
| Cognitive function evaluation (MoCA) | Percentage change from baseline in Montreal Cognitive Assessment (MoCA) score. | Up to 1 year after subculum-SEEG Guided RF-TC |
| Adverse Events | Rate of adverse events which were judged to be study-related throughout the study. | Up to 1 year after subculum-SEEG Guided RF-TC |
| Incidence of Sudden Unexpected Death in Epilepsy (SUDEP) | The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow-up. | Up to 1 year after subculum-SEEG Guided RF-TC |