Temporal Lobe Epilepsy (TLE)
Conditions
Keywords
Magnetic Resonance-guided Laser Interstitial Thermal Therapy, Open Surgery, Temporal Lobe Epilepsy
Brief summary
How does magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) impact clinical prognosis in mesial temporal lobe epilepsy (mTLE)?
Detailed description
1. Compare the clinical prognosis between magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) and traditional open surgery (OS) on patients with mesial temporal lobe epilepsy (mTLE). 2. Explore the factors associated with seizure outcomes.
Interventions
PROCEDUREResonance-guided Laser Interstitial Thermal Therapy (MRgLITT)
MRgLITT employs laser energy delivered through a stereotactically placed laser applicator to precisely ablate the epileptogenic tissue.
PROCEDUREOpen Surgery
Traditional Open Surgery
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 18-65 years. * Drug-resistant mesial temporal lobe epilepsy. * Seizure frequency ≥ 1 time /month. * Participants approved.
Exclusion criteria
* History of brain surgery. * Intracranial space occupying lesions. * Individuals with significant medical comorbidities or conditions that pose an excessive risk for surgery, such as severe cardiovascular disease, respiratory disorders, or uncontrolled systemic infections.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seizure freedom rate | 6-month, 1-year after surgery | According to International League Against Epilepsy \[ILAE\] Outcome Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seizure frequency | 6-month, 1-year after surgery | Times/Months |
| Seizure severity | 6-month, 1-year after surgery | National Hospital Seizure Severity Scale (NHS3) |
| Cognitive function evaluation | 6-month, 1-year after surgery | Multiple Ability Self-Report Questionnaire (MASQ) |
| Memory function evaluation | 6-month, 1-year after surgery | Multifactorial Memory Questionnaire (MMQ) |
| Quality of life for epilepsy patients | 6-month, 1-year after surgery | EQ-5D-5L |
| Adverse events | within 7 days, 6-month, 1-year after surgery | percentage |
| Severe adverse events | within 7 days, 6-month, 1-year after surgery | percentage |
| Length of hospital stay | after surgery | days |
| Rate of antiepileptic drug reduction or withdrawn | 1-year after surgery | percentage |
| Rate of reoperations | 1-year after surgery | percentage |
Countries
China
Contacts
CONTACTKai Zhang, Dr.
Outcome results
None listed