Stereotactic Laser Ablation for Temporal Lobe Epilepsy (SLATE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02844465 |
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Recruitment Status :
Recruiting
First Posted : July 26, 2016
Last Update Posted : November 22, 2019
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Sponsor:
Medtronic Navigation, Inc.
Information provided by (Responsible Party):
Medtronic Surgical Technologies ( Medtronic Navigation, Inc. )
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Brief Summary:
The study is designed to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for mesial temporal epilepsy (MTLE).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Temporal Lobe Epilepsy | Device: Visualase MRI-Guided Laser Ablation | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 150 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Stereotactic Laser Ablation for Temporal Lobe Epilepsy |
| Actual Study Start Date : | December 2016 |
| Estimated Primary Completion Date : | May 2022 |
| Estimated Study Completion Date : | May 2022 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Pyridoxal 5'-phosphate-dependent epilepsy
MedlinePlus related topics:
Epilepsy
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment
Visualase MRI-guided laser ablation procedure
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Device: Visualase MRI-Guided Laser Ablation
All subjects will undergo MRI-guided laser ablation of the amygdala and hippocampus with the Visualase System.
Other Names:
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Primary Outcome Measures :
- Incidence of qualifying adverse events [ Time Frame: 12 months ]
- Seizure freedom, defined as Engel Classification of Postoperative Outcome Class I [ Time Frame: 12 months ]
Secondary Outcome Measures :
- Seizure freedom compared to historical controls [ 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 Short Form-36 (SF-36) Health Survey scores [ Time Frame: Baseline and 12 months ]
- Change in Quality of Life in Epilepsy (QOLIE-31) scores [ Time Frame: Baseline and 12 months ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844465
Contacts
| Contact: Guy Alvarez, PhD | rs.slatestudy@medtronic.com |
Locations
Show 18 study locations
Sponsors and Collaborators
Medtronic Navigation, Inc.
Investigators
| Principal Investigator: | Robert Gross, MD, PhD | Emory University | |
| Principal Investigator: | Michael Sperling, MD | Thomas Jefferson University |
| Responsible Party: | Medtronic Navigation, Inc. |
| ClinicalTrials.gov Identifier: | NCT02844465 |
| Other Study ID Numbers: |
CS-05000 |
| First Posted: | July 26, 2016 Key Record Dates |
| Last Update Posted: | November 22, 2019 |
| Last Verified: | November 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | There is not a plan to share individual participant data, but aggregate data for all primary and secondary endpoints will be shared. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
Keywords provided by Medtronic Surgical Technologies ( Medtronic Navigation, Inc. ):
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epilepsy laser ablation Visualase laser interstitial thermal therapy |
Additional relevant MeSH terms:
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Epilepsy Epilepsy, Temporal Lobe Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Epilepsies, Partial Epileptic Syndromes |