Trial Outcomes & Findings for Feasibility Study on LITT for Medical Refractory Epilepsy (NCT NCT02820740)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

2 Years

Results posted on

2024-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	NeuroBlate LITT Treatment All eligible study subjects who underwent LITT with the NeuroBlate System.
Overall Study STARTED	4
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	NeuroBlate LITT Treatment All eligible study subjects who underwent LITT with the NeuroBlate System.
Overall Study Did not have procedure	2

Baseline Characteristics

Feasibility Study on LITT for Medical Refractory Epilepsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NeuroBlate LITT Treatment n=2 Participants All eligible study subjects who underwent LITT with the NeuroBlate System.
Age, Customized Age range	55 years n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	2 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	2 participants n=99 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	NeuroBlate LITT Treatment n=2 Participants All eligible study subjects who underwent LITT with the NeuroBlate System.
Number of Participants With Adverse Events	2 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	NeuroBlate LITT Treatment n=2 Participants All eligible study subjects who underwent LITT with the NeuroBlate System.
Changes in Neuropsychological Functioning Baseline Trails Making Trial A	29.5 Time in seconds Interval 24.0 to 35.0
Changes in Neuropsychological Functioning Baseline Trails Making Trial B	66 Time in seconds Interval 47.0 to 85.0
Changes in Neuropsychological Functioning 1 Year Trails Making A	32.5 Time in seconds Interval 26.0 to 39.0
Changes in Neuropsychological Functioning 1 Year Trails Making B	59.5 Time in seconds Interval 43.0 to 76.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	NeuroBlate LITT Treatment n=2 Participants All eligible study subjects who underwent LITT with the NeuroBlate System.
Changes in Seizure Frequency Seizures at baseline	22 Number of seizures/month Interval 8.0 to 34.0
Changes in Seizure Frequency Seizures at 24 Months	3 Number of seizures/month Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	NeuroBlate LITT Treatment n=2 Participants All eligible study subjects who underwent LITT with the NeuroBlate System.
Surgical Outcome Classification Engel Class III at 2 years	1 participants
Surgical Outcome Classification Engel Class I at 2 years	1 participants
Surgical Outcome Classification ILAE Class 4 at 2 years	1 participants
Surgical Outcome Classification ILAE Class 1 at 2 years	1 participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	NeuroBlate LITT Treatment n=2 Participants All eligible study subjects who underwent LITT with the NeuroBlate System.
Changes in Quality of Life Baseline QOLIE	53.91 QOLIE Score (0-100) Interval 26.14 to 81.68
Changes in Quality of Life 24 Month QOLIE	57.88 QOLIE Score (0-100) Interval 34.7 to 81.06

Adverse Events

NeuroBlate LITT Treatment

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	NeuroBlate LITT Treatment n=2 participants at risk All eligible study subjects who underwent LITT with the NeuroBlate System.
Nervous system disorders Tinnitus	50.0% 1/2 • Number of events 1 • Adverse events were collected from the time of patient consent (prior to the surgical procedure) to study withdraw/completion, up to 24 months. A planned study sample size of thirty (30) enrolled and treated subjects would allow events that have a 5% probability per-subject an approximately 80% chance of being observed in at least one subject in the study. Due to the inability to enroll in the FLARE study and early termination, there are insufficient data regarding adverse event rates. The two (2) reported events are captured for the patients who underwent LITT.
Gastrointestinal disorders Infection	50.0% 1/2 • Number of events 1 • Adverse events were collected from the time of patient consent (prior to the surgical procedure) to study withdraw/completion, up to 24 months. A planned study sample size of thirty (30) enrolled and treated subjects would allow events that have a 5% probability per-subject an approximately 80% chance of being observed in at least one subject in the study. Due to the inability to enroll in the FLARE study and early termination, there are insufficient data regarding adverse event rates. The two (2) reported events are captured for the patients who underwent LITT.

Other adverse events

Adverse event data not reported

Additional Information

Clinical Program Manager

Monteris Medical

Phone: 763-401-1727

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place