MRgLITT for mTLE: A PROBE Trial
ConditionTemporal Lobe Epilepsy (TLE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBeijing Tiantan Hospital
About this trial
How does magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) impact clinical prognosis in mesial temporal lobe epilepsy (mTLE)?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-65 years.
Drug-resistant mesial temporal lobe epilepsy.
Seizure frequency ≥ 1 time /month.
Participants approved.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT)
Procedure/SurgeryMRgLITT employs laser energy delivered through a stereotactically placed laser applicator to precisely ablate the epileptogenic tissue.
Open Surgery
Procedure/SurgeryTraditional Open Surgery
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Open Surgery (anterior temporal lobectomy, ATL)Experimental treatment 1 intervention
Group B: Minimally Invasive Surgery (MRgLITT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Seizure freedom rate
According to International League Against Epilepsy \[ILAE\] Outcome Scale
Time frame
6-month, 1-year after surgerySecondary outcomes
1
Seizure frequency
Times/Months
Time frame
6-month, 1-year after surgery2
Seizure severity
National Hospital Seizure Severity Scale (NHS3)
Time frame
6-month, 1-year after surgery3
Cognitive function evaluation
Multiple Ability Self-Report Questionnaire (MASQ)
Time frame
6-month, 1-year after surgery4
Memory function evaluation
Multifactorial Memory Questionnaire (MMQ)
Time frame
6-month, 1-year after surgerySponsors and contacts
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Source ClinicalTrials.gov