Breakthrough Clinical Results
Monteris Medical announced the publication of a landmark study in JAMA Neurology demonstrating the safety, durability, and efficacy of laser interstitial thermal therapy (LITT) using the NeuroBlate System for drug-resistant mesial temporal lobe epilepsy (MTLE). The study, involving 145 patients across 15 U.S. institutions, showed long-term seizure freedom outcomes comparable to anterior temporal lobectomy (ATL), with significant improvements in quality of life and shorter recovery times. The minimally invasive nature of the NeuroBlate procedure resulted in shorter hospital stays and faster patient recovery compared to traditional surgery. The results confirm LITT as a viable treatment option for both adult and pediatric patients with MTLE.
Key Highlights
- Largest prospective study of LITT for drug-resistant epilepsy published in JAMA Neurology.
- Long-term seizure freedom outcomes comparable to anterior temporal lobectomy (ATL).
- Minimally invasive procedure with shorter hospital stays and faster recovery.
- Comparable outcomes observed in both adult and pediatric patients.
Incidence and Prevalence
Latest Global Estimates of Epilepsy Prevalence and Incidence
Epilepsy remains one of the most common neurological disorders worldwide, affecting a significant portion of the global population. According to the most recent data from 2024, there are approximately 50 million epilepsy patients worldwide, though some reports suggest the number could be as high as 70 million people.
The global prevalence of epilepsy has historically been cited as affecting approximately 1% of the world's population. However, recent epidemiological trends show concerning increases. The global age-standardized prevalence rate has increased by 29.61% over the past 30 years as of 2024. Analysis using the APC (Age-Period-Cohort) model estimated the net drift of prevalence was 0.88% per year globally.
The geographical distribution of epilepsy is notably uneven, with nearly 80% of people with epilepsy living in resource-constrained low-income and middle-income countries. In Asia, which represents 50% of the world's population with over 4 billion people, about 23 million people have epilepsy.
The disease burden of epilepsy is substantial and increasing. The global age-standardized rate of Years Lived with Disability (YLDs) has increased by 27.02% over the past 30 years. The APC model estimated the net drift of YLDs at 0.80% per year globally. Among 204 countries and territories analyzed, prevalence showed an increasing trend in 164 locations, while YLDs showed an increasing trend in 146 locations.
Age-related patterns show that the risk of YLDs and prevalence increases with age, with the lowest risk among 0-4 years old and the highest risk among 75-79 years old.
Mortality rates for epilepsy have also been rising. The age-adjusted mortality from epilepsy increased from 0.78 per 100,000 population in 1979 to 1.01 per 100,000 population in 2021, with an average annual percent change (AAPC) in mortality of 0.58%. The overall age-adjusted mortality of epilepsy had been on the rise between 2011 and 2021. Mortality rates generally increase with age and are higher in Afro-American people and men.
Regional data from China shows annual mortality associated with epilepsy ranging from 3.0-7.9 deaths per 100,000 people, with a standardized mortality ratio (SMR) of 3.9 in rural areas. In India, the age-adjusted prevalence rate of epilepsy was 4.71 per 1000, with an age-adjusted annual incidence rate of 38.3 per 100,000.
Despite advances in treatment, approximately 30% of epileptic patients do not favorably respond to antiepileptic drug treatment, meaning one-third of epilepsy patients remain refractory to medication. This treatment-resistant population faces significant impacts on daily activities, social well-being, independence, economic output, and quality of life.
Study Design Parameters
Study Design Parameters and Endpoints in Key Epilepsy Trials
Study Designs
- Cross-sectional studies evaluate prevalence of conditions like suicidal ideation (29.8%)
- Open-label, prospective studies assess drug efficacy, including lamotrigine add-on therapy
- Retrospective reviews analyze outcomes of procedures like selective PCA Wada test
- Pragmatic randomized clinical trials like the SANAD study address clinically relevant questions
- Randomized controlled trials (RCTs) and quasi-RCTs compare treatments such as oral clonazepam versus placebo
- Case studies nested within controlled trials evaluate specialist nurse-led services
- Telementoring using ECHO methodology for educational interventions
Study Phases and Duration
- Studies typically include baseline periods (3 months), titration periods (e.g., 4 months), and maintenance periods (e.g., 9 months)
- Follow-up periods range from 6 months to mean 6.5 years
- Treatment periods in RCTs range from 7 to 16 weeks
Patient Populations
- Adults with drug-resistant epilepsy (defined as failure of at least two antiepileptic drugs)
- Elderly patients (60+ years)
- Institutionalized patients with multiple handicaps
- School-age children
- Patients with specific seizure types (e.g., epileptic drop attacks, complex partial seizures)
- Age ranges vary (e.g., 17-78 years in a 2008 levetiracetam study)
Treatment Arms
- Monotherapy versus polytherapy comparisons
- Add-on versus substitution strategies for new AEDs
- Drug-specific comparisons (e.g., clonazepam vs. carbamazepine)
Assessment Methods
- Seizure diaries track frequency and severity
- Regular clinical evaluations (typically every 3 months)
- Hematological testing and plasma level monitoring
- EEG evaluations including video-EEG monitoring
- Neuropsychological testing
- MRI and EEG-fMRI for epileptogenic focus localization
- Standardized questionnaires for knowledge assessment
Primary Endpoints
- Seizure frequency reduction (≥50% reduction considered significant)
- Seizure freedom rates
- Seizure-related exit rate based on discontinuation criteria
- Seizure freedom up to 24 hours from medication administration for seizure clusters
- EEG improvement (e.g., disappearance of secondary bilateral synchrony)
- Memory outcomes after surgical procedures
- Engel Class I (seizure-free) status post-surgery (77% in one study)
Secondary Endpoints
- Treatment withdrawal for any reason or due to adverse events
- Adverse events incidence (reported in 20% of patients in topiramate study)
- Time to treatment withdrawal
- Time to remission (6-month and 12-month)
- Time to first seizure post randomization
- Adherence rate at various timepoints
- Risk of evolution into Status Epilepticus
- Quality of life assessments
- Knowledge and self-efficacy improvements in educational interventions
Challenges in Trial Design
- Participant recruitment and retention has become increasingly difficult
- Number of participants per site has steadily decreased over decades
- Placebo response has increased over time
NeuroBlate System Clinical Trials Beyond Epilepsy
I don't have specific information about the NeuroBlate System's clinical trials for indications other than epilepsy or their intervention models. The provided context does not contain details about the NeuroBlate System, its applications, or any clinical trials it is being used in.
To properly answer this question would require information about:
- Current clinical trials using the NeuroBlate System for various neurological or oncological conditions
- Specific intervention protocols being tested
- Treatment parameters for different indications
- Patient selection criteria across various trials
- Outcome measures being evaluated
The NeuroBlate System appears to be a form of MRI-guided laser interstitial thermal therapy, which is typically used for minimally invasive neurosurgical applications, but without additional context, I cannot provide specific details about its trials beyond epilepsy treatment.