Temporal Lobe EpilepsySLATENCT02844465
Stereotactic Laser Ablation for Temporal Lobe Epilepsy (Slate)
A study testing Visualase MRI-Guided Laser Ablation in people with Temporal Lobe Epilepsy, run by MedtronicNeuro at 23 sites in United States.
Trial summary
The study is designed to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for mesial temporal epilepsy (MTLE). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Temporal Lobe Epilepsy
- What is being tested?
- Visualase MRI-Guided Laser Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 23 sitesUnited States
- Study dates
- Dec 2016to 11 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of drug-resistant mesial temporal lobe epilepsy (MTLE)
- If the subject has a vagus nerve stimulator (VNS), must have failed to achieve sustained seizure freedom with the VNS implanted for at least 6 months
- On stable antiepileptic drugs (AEDs) (and/or stable VNS setting, if applicable) and compliant with medication use
- An average of at least 1 complex partial or secondarily generalized seizure compatible with MTLE per month
- Seizure symptoms and/or auras compatible with MTLE
- Video EEG shows evidence of seizures from one temporal lobe consistent with MTLE
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- MRI has evidence consistent with mesial temporal lobe sclerosis
- Willing and able to remain on stable AEDs (and stable VNS setting, if applicable) for 12 months following the Visualase procedure
- Willing and able to comply with protocol requirements
- Able to complete study assessments in English or Spanish language
Who cannot join
- Unwilling or unable to sign the study informed consent form
- Pregnant or intends to become pregnant during the course of the study
- Currently implanted with a device contraindicating MRI
- Progressive brain lesions and/or tumors not associated with epileptic disease state
- History of previous intracranial surgery for treatment of epileptic seizures
- Persistent extra-temporal or predominant contralateral focal interictal spikes or slowing, or generalized interictal spikes on EEG
Show all 16Show fewer
- Seizures with contralateral or extra-temporal ictal onset on EEG
- Aura and/or ictal behavior suggest an extra-temporal focus
- MRI evidence of epileptogenic, extra-temporal lesions, dual pathology in the temporal lobe, or contralateral hippocampal MRI increased signal and/or loss of architecture
- If additional testing has been performed, results are discordant with the seizure focus scheduled for ablation
- Non-compliance with AED requirements
- IQ < 70
- Dementia or other progressive neurological disease
- Unstable major psychiatric illness, psychogenic non-epileptic seizures, or medical illness that would contraindicate the Visualase procedure or affect the neuropsychological assessments
- Participation in other research that may potentially interfere with SLATE endpoint(s)
- Allergy to gadolinium
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Emory University
Atlanta, Georgia, 30322
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21287
University of Virginia
Charlottesville, Virginia, 22903
University of Chicago
Chicago, Illinois, 60637
Ohio Health Research Institute
Columbus, Ohio, 43214
Henry Ford Health System
Detroit, Michigan, 48202
Northwell Health
Great Neck, New York, 11021
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
University of Louisville Hospital
Louisville, Kentucky, 40202
University of Miami
Miami, Florida, 33136
Rutgers University - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Columbia University Medical Center
New York, New York, 10032
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92688
Stanford University
Palo Alto, California, 94305
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Oregon Health & University Science
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
University of California, San Francisco
San Francisco, California, 94143
University of Washington Harborview
Seattle, Washington, 98104
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: Stereotactic Laser Ablation for Temporal Lobe Epilepsy
The study is designed to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for mesial temporal epilepsy (MTLE).
Read the detailed description
The purpose of the study is to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for necrotization or coagulation of epileptogenic foci in patients with intractable mesial temporal lobe epilepsy.
The study will include approximately 150 adult patients with drug-resistant MTLE treated at selected epilepsy centers across the United States. After the Visualase procedure, patients will be followed for 12 months and evaluated for freedom from seizures, quality of life, adverse events, and neuropsychological outcomes.
- Conditions
- Temporal Lobe Epilepsy
- Being tested
- Visualase MRI-Guided Laser Ablation
- Keywords
- epilepsy, laser ablation, Visualase, laser interstitial thermal therapy
- Medical subject headings
- Epilepsy, Temporal Lobe, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visualase MRI-Guided Laser AblationDevice
Also called Visualase System, Visualase procedure, Laser interstitial thermal therapy, Stereotactic laser ablation
All subjects will undergo MRI-guided laser ablation of the amygdala and hippocampus with the Visualase System.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Visualase MRI-guided laser ablation procedure Receives: Device: Visualase MRI-Guided Laser Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Qualifying Adverse Events
The incidence of qualifying device, procedure and/or anesthesia related adverse events. These events must also be moderate or severe and permanent for the following AEs: anxiety, aphasia, blurry vision, depression, diplopia, emotional lability, hemianopia, hemiparesis, memory impairment/difficulty, neurologic deficits, paralysis, psychological/psychiatric complications, quadrantanopia, sensory loss, sleep problems or insomnia. An exact 95% confidence interval (CI) will be calculated to determine if the upper bound of the CI for qualified AEs is less than 40%.
Measured: 12 months
Seizure Freedom, Defined as Engel Classification of Postoperative Outcome Class I
Seizure freedom at 12 months following the Visualase procedure (starting at 30 days post-procedure through 365 days post procedure). Engel Class I: Free of disabling seizures includes subclasses: A. Completely seizure free since surgery, B. Nondisabling simple partial seizures only since surgery, D. Generalized convulsions with antiepileptic drugs (AED) discontinuation only. An exact 95% CI will be calculated to determine if the lower bound of the CI for seizure freedom at 12 months following the Visualase procedure will be greater than 43%. Multiple imputation was used if subject diary data was not compliant. Retreated subjects are treated as failures.
Measured: 12 months
Secondary outcomes (8)
Seizure Freedom Compared to Historical Controls (Medical Therapy)
Seizure freedom (Engel Class I) compared to historical control for continued medical therapy. It is hypothesized that the seizure freedom at 12 months following the Visualase procedure will be superior to 8% reported in the literature for continued medical therapy. An exact 95% CI for the percentage of subjects who are seizure free will be calculated.
Measured: 12 months
Seizure Freedom, Including Subjects Retreated With Visualase
Seizure freedom (Engel Class I) including subjects who were retreated with Visualase. The outcome after retreatment will count towards the endpoint. It is hypothesized that the lower bound of the 95% CI for seizure freedom at 12 months following the Visualase procedure, including subjects retreated with Visualase, will be greater than 43%. Subjects retreated with Visualase will count toward the secondary efficacy endpoint based on their outcome after retreatment. If they have become seizure free and have reached 12 months follow-up from time of retreatment, they are counted as seizure free. Otherwise, they will count as not seizure free. An exact 95% CI will be calculated to determine if the lower bound of the CI for seizure freedom at 12 months following a subject's last Visualase procedure, including patients retreated with Visualase, will be greater than 43%.
Measured: 12 months
Change in Boston Naming Test Scores
Within-subject change of Boston Naming Test score (English language version) from baseline to 12 months following the Visualase procedure. The Boston Naming Test is a neuropsychological assessment tool to measure confrontational word retrieval. The test contains 60 line drawings graded in difficulty which the participants need to name. The total score ranges from 0-60 with a higher score meaning a better outcome.
Measured: Baseline and 12 months
Change in Rey Auditory Verbal Learning Test Scores
Within-subject change of Rey Auditory Verbal Learning Test (RAVLT) 5-Trial Total score (English language version) from baseline to 12 months following the Visualase procedure. It is used for assessing episodic memory by providing scores for evaluating different aspects of memory. The RAVLT presents a list of 15 words across 5 consecutive trials. The list is read to the participant and the participant is asked to recall as many words as possible. This is repeated for 5 consecutive trials. The scores range from 0-75 with a higher score indicating a better outcome.
Measured: Baseline and 12 months
Change in Quality of Life in Epilepsy (QOLIE-31) Scores
Within-subject change of the QOLIE-31 score (English language version) from baseline to 12 months following the Visualase procedure, categorized as -1 if the decrease is clinically significant (<= -11.8), categorized as 0 if not clinically significant (-11.7 to +11.7), and categorized as +1 if the increase is clinically significant (>= 11.8). The QOLIE-31 evaluates a participant's quality of life in relation to their epilepsy. It is used to asses a person's overall wellness, including their social functioning and cognitive impact. The QOLIE scores range from 0-100 with a higher score meaning a better outcome.
Measured: Baseline and 12 months
Change in SF-36 Mental Component Score
Within-subject change of short form (SF)-36 quality of life questionnaire Mental Component Score (English language version) from baseline to 12 month following the Visualase procedure, categorized as -1 if the decrease is clinically significant (<=-4.58), categorized as 0 if not clinically significant (-4.57 to +4.57), and categorized as +1 if the increase is clinically significant (>=4.58). The SF-36 is a 36-item, patient-reported survey of patient health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The SF-36 Mental Component Score ranges from 0-100 with a higher score meaning a better outcome, on the assumption that each questions carries equal weight.
Measured: Baseline and 12 Months
Change in SF-36 Physical Component Score
Within-subject change of short form (SF)-36 quality of life questionnaire Physical Component Score (English language version) from baseline to 12 month following the Visualase procedure, categorized as -1 if the decrease is clinically significant (<=-3.02), categorized as 0 if not clinically significant (-3.01 to +3.01), and categorized as +1 if the increase is clinically significant (>=3.02). The SF-36 is a 36-item, patient-reported survey of patient health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The SF-36 Physical Component Scores range from 0-100 with a higher score meaning a better outcome, on the assumption that each questions carries equal weight.
Measured: Baseline and 12 Months
Seizure Freedom Compared to Historical Controls (Open Surgical Resection)
Seizure freedom (Engel Class I) compared to historical control for open surgical resection.
It is hypothesized that the seizure freedom at 12 months following the Visualase procedure will not be inferior to 64% reported in the literature for open surgical resection.
An exact 95% CI for the percentage of subjects who are seizure free will be calculated and its lower boundary compared to zero after subtraction of the historical open surgical resection percentage of 64% and the addition of the equivalence delta percentage of 10%.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startDec 2016
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Temporal Lobe EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Gross, MD, PhD, Principal investigator, Emory UniversityMichael Sperling, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844465
- Sponsor's protocol ID
- CS-05000
- Acronym
- SLATE
- Status last verified
- Jan 2025
- First submitted
- 15 Jul 2016
- Last updated
- 17 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is not a plan to share individual participant data, but aggregate data for all primary and secondary endpoints will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Laser Ablation for Temporal Lobe Epilepsy
- ClinicalTrials.gov ID
- NCT02844465
- Acronym / sponsor ID
- SLATE / CS-05000
- Conditions
- Temporal Lobe Epilepsy
- Keywords
- epilepsy, laser ablation, Visualase, laser interstitial thermal therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Posted 17 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for mesial temporal epilepsy (MTLE).
Detailed description
The purpose of the study is to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for necrotization or coagulation of epileptogenic foci in patients with intractable mesial temporal lobe epilepsy.
The study will include approximately 150 adult patients with drug-resistant MTLE treated at selected epilepsy centers across the United States. After the Visualase procedure, patients will be followed for 12 months and evaluated for freedom from seizures, quality of life, adverse events, and neuropsychological outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Visualase MRI-Guided Laser AblationVisualase MRI-guided laser ablation procedure |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- History of drug-resistant mesial temporal lobe epilepsy (MTLE)
- If the subject has a vagus nerve stimulator (VNS), must have failed to achieve sustained seizure freedom with the VNS implanted for at least 6 months
- On stable antiepileptic drugs (AEDs) (and/or stable VNS setting, if applicable) and compliant with medication use
- An average of at least 1 complex partial or secondarily generalized seizure compatible with MTLE per month
- Seizure symptoms and/or auras compatible with MTLE
Key exclusion criteria (16 listed)
- Unwilling or unable to sign the study informed consent form
- Pregnant or intends to become pregnant during the course of the study
- Currently implanted with a device contraindicating MRI
- Progressive brain lesions and/or tumors not associated with epileptic disease state
- History of previous intracranial surgery for treatment of epileptic seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visualase MRI-Guided Laser AblationAlso: Visualase System, Visualase procedure, Laser interstitial thermal therapy, Stereotactic laser ablationAll subjects will undergo MRI-guided laser ablation of the amygdala and hippocampus with the Visualase System. | Device | Treatment |
Primary outcome
Incidence of Qualifying Adverse Events
Time frame: 12 months
The incidence of qualifying device, procedure and/or anesthesia related adverse events. These events must also be moderate or severe and permanent for the following AEs: anxiety, aphasia, blurry vision, depression, diplopia, emotional lability, hemianopia, hemiparesis, memory impairment/difficulty, neurologic deficits, paralysis, psychological/psychiatric complications, quadrantanopia, sensory loss, sleep problems or insomnia. An exact 95% confidence interval (CI) will be calculated to determine if the upper bound of the CI for qualified AEs is less than 40%.
Seizure Freedom, Defined as Engel Classification of Postoperative Outcome Class I
Time frame: 12 months
Seizure freedom at 12 months following the Visualase procedure (starting at 30 days post-procedure through 365 days post procedure). Engel Class I: Free of disabling seizures includes subclasses: A. Completely seizure free since surgery, B. Nondisabling simple partial seizures only since surgery, D. Generalized convulsions with antiepileptic drugs (AED) discontinuation only. An exact 95% CI will be calculated to determine if the lower bound of the CI for seizure freedom at 12 months following the Visualase procedure will be greater than 43%. Multiple imputation was used if subject diary data was not compliant. Retreated subjects are treated as failures.
8 secondary outcomes
Seizure Freedom Compared to Historical Controls (Medical Therapy)
Time frame: 12 months
Seizure Freedom, Including Subjects Retreated With Visualase
Time frame: 12 months
Change in Boston Naming Test Scores
Time frame: Baseline and 12 months
Change in Rey Auditory Verbal Learning Test Scores
Time frame: Baseline and 12 months
Change in Quality of Life in Epilepsy (QOLIE-31) Scores
Time frame: Baseline and 12 months
Change in SF-36 Mental Component Score
Time frame: Baseline and 12 Months
Change in SF-36 Physical Component Score
Time frame: Baseline and 12 Months
Seizure Freedom Compared to Historical Controls (Open Surgical Resection)
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is not a plan to share individual participant data, but aggregate data for all primary and secondary endpoints will be shared.
Related trials for Temporal Lobe Epilepsy
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Mesial Temporal Lobe Epilepsy
RecruitingObservational study
Investigating Epilepsy: Screening and Evaluation
Seizures, Epilepsy
RecruitingObservational study
Surgery as a Treatment for Medically Intractable Epilepsy
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Recruiting
Overnight TI in TLE
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RecruitingEarly Phase 1
Pharmacological Modulation of Brain Oscillations in Memory Processing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Gross, MD, PhD principal investigator
Emory University
Michael Sperling, MD principal investigator
Thomas Jefferson University
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visualase MRI-Guided Laser Ablation in people with Temporal Lobe Epilepsy, run by MedtronicNeuro at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Qualifying Adverse Events (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.