Minimally invasive surgery for temporal lobe epilepsy
Functional Anterior Temporal Lobectomy Via Minicraniotomy as a Novel Surgical Therapy for Temporal Lobe Epilepsy: a Randomized, Controlled Trial
This study tests a new, less invasive surgery for people with drug-resistant temporal lobe epilepsy to see if it can reduce seizures and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital Xi'an Jiaotong University Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT05019404 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of functional anterior temporal lobectomy (FATL) performed via a minimally invasive approach for patients with drug-resistant temporal lobe epilepsy (TLE). The study aims to assess the outcomes of this new surgical technique, which has not been previously reported. Participants will be closely monitored for seizure reduction and overall quality of life following the procedure. The trial includes a rigorous selection process to ensure that only eligible patients with specific criteria are enrolled.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with drug-resistant temporal lobe epilepsy who have experienced monthly seizures despite treatment.
Not a fit: Patients with tumors in the temporal lobe, extratemporal epilepsy, or those who are drug-responsive may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve seizure control and quality of life for patients with temporal lobe epilepsy.
How similar studies have performed: While traditional anterior temporal lobectomy has shown success, this specific minimally invasive approach is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Xi'an, Shaanxi
- First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Yong Liu, MD
- Email: liu868yong@163.com
- Phone: +8618049529896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.