Minimally Invasive Surgical Epilepsy Trial for Temporal Lobe Epilepsy

Launched by FIRST AFFILIATED HOSPITAL XI'AN JIAOTONG UNIVERSITY · Aug 22, 2021

Keywords

ClinConnect Summary

The Minimally Invasive Surgical Epilepsy Trial is studying a new type of surgery for people with temporal lobe epilepsy (TLE), a condition that causes frequent and often severe seizures. This trial will explore a specific surgical technique called functional anterior temporal lobectomy (FATL), which is performed through a smaller opening in the skull, making it less invasive than traditional surgery. Previous studies have shown that surgery can be more effective than medication for controlling TLE, but this is the first time this less invasive approach is being evaluated.

To be eligible for the trial, participants must be between 18 and 60 years old and have TLE that does not respond to at least two different anti-seizure medications. They should have been experiencing seizures at least once a month over the last year. It's important that participants can understand the study and provide consent. Those with certain conditions, such as a brain tumor or other types of epilepsy, will not be eligible. If someone joins the study, they can expect to receive the new surgical treatment and will need to follow up for at least a year to see how well it works. This trial aims to find out if this new method can help improve the lives of people living with TLE.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. male or female aged between 18 and 60 years;
• • 2. drug- resistant temporal lobe epilepsy, remaining seizures after two or more tolerated and appropriately chosen antiepileptic drugs;
• • 3. monthly or more seizures during the preceding year prior to trial;
• • 4. the full- scale intelligence quotient (IQ) more than 70, understanding and completing the trial;
• • 5. signing the informed consent;
• • 6. good compliance, at least 12- month follow- up after surgery.
• Exclusion Criteria:
• • 1. tumor in temporal lobe;
• • 2. extratemporal epilepsy and temporal plus epilepsy;
• • 3. drug- responsive epilepsy, seizure freedom with current drugs in recent one year;
• • 4. pseudoseizures;
• • 5. seizures arising from bilateral temporal lobes;
• • 6. significant comorbidities including progressive neurological disorders, active psychosis, and drug abuse;
• • 7. a full- scale IQ lower than 70, unable to complete tests;
• • 8. previous epilepsy surgery;
• • 9. poor compliance and inadequate follow- up.