Epilepsy
Conditions
Keywords
Epilepsy, Medial Temporal Lobe Epilepsy, Seizure, NeuroBlate, LITT, Quality of Life
Brief summary
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.
Detailed description
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.
Interventions
DEVICENeuroBlate System
Laser Interstitial Thermal Therapy
Sponsors
Monteris Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Relevant Inclusion Criteria are listed below * Diagnosis of unilateral medial temporal lobe epilepsy (MTLE) confirmed clinically and with either (1) ictal scalp recording and MRI evidence of mesial temporal sclerosis or (2) intracranial ictal onset consistent with hippocampal origin * Averages 1 or more complex partial seizures or secondary generalized seizures compatible with MTLE per month * On stable antiepileptic medications * Meets the criteria for a medial temporal lobe resection and is a candidate for LITT * 18 years or older at the time of consent Relevant
Exclusion criteria
are listed below * Previous diagnosis of psychogenic/non-epileptic seizures * Previous diagnosis of primary generalized seizures * IQ less than 70 * Subject has a MRI-incompatible implanted electronic device or any metallic prosthesis or implant for which brain MRI is contraindicated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 2 Years | 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. |
| Changes in Neuropsychological Functioning | 1 Year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Seizure Frequency | 2 Years | 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. |
| Surgical Outcome Classification | 2 Years | 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 |
| Changes in Quality of Life | 2 Years | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NeuroBlate LITT Treatment All eligible study subjects who underwent LITT with the NeuroBlate System. | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not have procedure | 2 |
Baseline characteristics
| Characteristic | NeuroBlate LITT Treatment |
|---|---|
| Age, Customized Age range | 55 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 2 / 2 |
Outcome results
Primary
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
Population: The per-protocol analysis was not completed because the study was terminated early and the data collected was insufficient for the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| NeuroBlate LITT Treatment | Changes in Neuropsychological Functioning | Baseline Trails Making Trial A | 29.5 Time in seconds |
| NeuroBlate LITT Treatment | Changes in Neuropsychological Functioning | Baseline Trails Making Trial B | 66 Time in seconds |
| NeuroBlate LITT Treatment | Changes in Neuropsychological Functioning | 1 Year Trails Making A | 32.5 Time in seconds |
| NeuroBlate LITT Treatment | Changes in Neuropsychological Functioning | 1 Year Trails Making B | 59.5 Time in seconds |
Primary
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
Population: The per-protocol analysis was not completed because the study was terminated early and the data collected was insufficient for the analysis despite two subjects completing the study at 24 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NeuroBlate LITT Treatment | Number of Participants With Adverse Events | 2 Participants |
Secondary
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
Population: The per-protocol analysis was not completed because the study was terminated early and the data collected was insufficient for the analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| NeuroBlate LITT Treatment | Changes in Quality of Life | Baseline QOLIE | 53.91 QOLIE Score (0-100) |
| NeuroBlate LITT Treatment | Changes in Quality of Life | 24 Month QOLIE | 57.88 QOLIE Score (0-100) |
Secondary
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
Population: The per-protocol analysis was not completed because the study was terminated early and the data collected was insufficient for the analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| NeuroBlate LITT Treatment | Changes in Seizure Frequency | Seizures at baseline | 22 Number of seizures/month |
| NeuroBlate LITT Treatment | Changes in Seizure Frequency | Seizures at 24 Months | 3 Number of seizures/month |
Secondary
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
Population: The per-protocol analysis was not completed because the study was terminated early and the data collected was insufficient for the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NeuroBlate LITT Treatment | Surgical Outcome Classification | Engel Class III at 2 years | 1 participants |
| NeuroBlate LITT Treatment | Surgical Outcome Classification | Engel Class I at 2 years | 1 participants |
| NeuroBlate LITT Treatment | Surgical Outcome Classification | ILAE Class 4 at 2 years | 1 participants |
| NeuroBlate LITT Treatment | Surgical Outcome Classification | ILAE Class 1 at 2 years | 1 participants |