An interventional study of NeuroBlate System in Epilepsy, sponsored by Monteris Medical. Terminated at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-12.
Sponsored by Monteris Medical · Not applicable, Interventional, and Treatment
Multicenter, open-label, prospective designed study to characterize the performance of brain laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System for the treatment of drug-refractory medial temporal lobe epilepsy in subjects who are candidates for LITT surgery.
Monteris is sponsoring this multicenter, open-label, prospective feasibility study to characterize the performance of laser interstitial thermal therapy (LITT) using the Monteris NeuroBlate System for the treatment of drug-refractory medial temporal lobe epilepsy in subjects who are candidates for LITT surgery.
The NeuroBlate System uses precise, high-intensity laser light to initiate necrosis of abnormal brain tissue through thermal ablation while limiting injury to healthy tissue. Unlike traditional brain surgery, LITT does not require a large opening in the skull.
Subjects who meet the study eligibility criteria and sign the informed consent form will undergo the LITT procedure. Subjects, or their caregivers, are required to keep a seizure diary throughout the study, beginning after surgery. The study will monitor and record subjects' seizure frequency, antiepileptic medications, and physical and emotional health.
Subjects treated with NeuroBlate will have 2 years of follow-up. Throughout study participation, the study investigator will continuously monitor and document both effectiveness and safety data at study appointments.
1,804 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 4 is below the median of 50 across 1,205 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Monteris Medical is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Relevant Inclusion Criteria are listed below
Relevant Exclusion Criteria are listed below
This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System.
Device: NeuroBlate System
Laser Interstitial Thermal Therapy
Number of Participants With Adverse Events
Characterize adverse events experienced in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System. Adverse events will be collected based on subject reports and subject examination/testing.
Time frame: 2 Years
Changes in Neuropsychological Functioning
Characterize changes to neuropsychological functioning experienced in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System. Descriptive statistics (via neuropsychological assessment tools) will be reported for the measured score at baseline and each follow-up visit.
Time frame: 1 Year
Changes in Seizure Frequency
Characterize changes in seizure frequency experienced in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System by utilizing patient diary to evaluate seizure occurrences.
Time frame: 2 Years
Surgical Outcome Classification
Characterize the Engel and ILAE surgical outcome classification in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System. Classifications will be determined by the Investigator. Engel Scale Class I: Free of disabling seizures Class II: Rare disabling seizures Class III: Worthwhile improvement Class IV: No worthwhile improvement ILAE Outcome Scale Class 1: Completely seizure free; no auras Class 2: Only auras; no other seizures Class 3: 1 to 3 seizure days per year; ± auras Class 4: 4 seizure days per year to 50% reduction of baseline seizure days; ± auras Class 5: Less than 50% reduction of baseline seizure days; ± auras Class 6: More than 100% increase of baseline seizure days; ± auras
Time frame: 2 Years
Changes in Quality of Life
Characterize the changes in quality of life in subjects with medical temporal lobe epilepsy undergoing LITT using the NeuroBlate System. Quality of life will be measured using the QOLIE-31 (Quality of Life in Epilepsy) questionnaire. Score scale 0-100 with 100 indicating a higher reported quality of life across seven different categories (seizure worry, overall quality of life, social functioning, emotional wellbeing, medication effects, energy/fatigue, and cognitive functioning).
Time frame: 2 Years
| Milestone | NeuroBlate LITT Treatment |
|---|---|
| Started | 4 |
| Completed | 2 |
| Not completed | 2 |
| Withdrew: Did not have procedure | 2 |
Characterize adverse events experienced in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System. Adverse events will be collected based on subject reports and subject examination/testing.
| Participants | NeuroBlate LITT Treatment |
|---|---|
| Number of Participants With Adverse Events | 2 |
Characterize changes to neuropsychological functioning experienced in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System. Descriptive statistics (via neuropsychological assessment tools) will be reported for the measured score at baseline and each follow-up visit.
| Time in seconds | NeuroBlate LITT Treatment |
|---|---|
| Baseline Trails Making Trial A | 29.5 (24 to 35) |
| Baseline Trails Making Trial B | 66 (47 to 85) |
| 1 Year Trails Making A | 32.5 (26 to 39) |
| 1 Year Trails Making B | 59.5 (43 to 76) |
Characterize changes in seizure frequency experienced in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System by utilizing patient diary to evaluate seizure occurrences.
| Number of seizures/month | NeuroBlate LITT Treatment |
|---|---|
| Seizures at baseline | 22 (8 to 34) |
| Seizures at 24 Months | 3 (0 to 6) |
Characterize the Engel and ILAE surgical outcome classification in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System. Classifications will be determined by the Investigator. Engel Scale Class I: Free of disabling seizures Class II: Rare disabling seizures Class III: Worthwhile improvement Class IV: No worthwhile improvement ILAE Outcome Scale Class 1: Completely seizure free; no auras Class 2: Only auras; no other seizures Class 3: 1 to 3 seizure days per year; ± auras Class 4: 4 seizure days per year to 50% reduction of baseline seizure days; ± auras Class 5: Less than 50% reduction of baseline seizure days; ± auras Class 6: More than 100% increase of baseline seizure days; ± auras
| participants | NeuroBlate LITT Treatment |
|---|---|
| Engel Class III at 2 years | 1 |
| Engel Class I at 2 years | 1 |
| ILAE Class 4 at 2 years | 1 |
| ILAE Class 1 at 2 years | 1 |
Characterize the changes in quality of life in subjects with medical temporal lobe epilepsy undergoing LITT using the NeuroBlate System. Quality of life will be measured using the QOLIE-31 (Quality of Life in Epilepsy) questionnaire. Score scale 0-100 with 100 indicating a higher reported quality of life across seven different categories (seizure worry, overall quality of life, social functioning, emotional wellbeing, medication effects, energy/fatigue, and cognitive functioning).
| QOLIE Score (0-100) | NeuroBlate LITT Treatment |
|---|---|
| Baseline QOLIE | 53.91 (26.14 to 81.68) |
| 24 Month QOLIE | 57.88 (34.7 to 81.06) |
Collected over Adverse events were collected from the time of patient consent (prior to the surgical procedure) to study withdraw/completion, up to 24 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NeuroBlate LITT Treatment | 0/2 (0%) | 2/2 (100%) | 0/2 (0%) |
| Event | NeuroBlate LITT Treatment |
|---|---|
| TinnitusNervous system disorders | 1/2 |
| InfectionGastrointestinal disorders | 1/2 |
| Age, Customized(years) | NeuroBlate LITT Treatment |
|---|---|
| Age range | 55 (53 to 57) |
| Sex: Female, Male(Participants) | NeuroBlate LITT Treatment |
|---|---|
| Female | 1 |
| Male | 1 |
| Race (NIH/OMB)(Participants) | NeuroBlate LITT Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | NeuroBlate LITT Treatment |
|---|---|
| United States | 2 |
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