NCT02844465Completed
Stereotactic Laser Ablation for Temporal Lobe Epilepsy (Slate)
Stereotactic Laser Ablation for Temporal Lobe Epilepsy
Source: ClinicalTrials.gov · Last updated 17 Jan 2025
Brief summary (registry, in English)
The study is designed to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for mesial temporal epilepsy (MTLE).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 167 (actual)
- First submitted
- 15 Jul 2016
- Start date
- Dec 2016
- Primary completion date
- 11 Dec 2023
- Lead sponsor
- MedtronicNeuro
- Diseases
- Epilepsy
- NCT number
- NCT02844465
What you commit to
- Study type: Interventional
- Participants enrolled: 167
- From Dec 2016 to the primary completion date, 11 Dec 2023
- 23 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous intracranial surgery for treatment of epileptic seizures
Other illness
- Progressive brain lesions and/or tumors not associated with epileptic disease state
- Seizures with contralateral or extra-temporal ictal onset on EEG
- If additional testing has been performed, results are discordant with the seizure focus scheduled for ablation
- 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
- Allergy to gadolinium
Other
- 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
- Persistent extra-temporal or predominant contralateral focal interictal spikes or slowing, or generalized interictal spikes 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
- Non-compliance with AED requirements
- IQ \< 70
- Participation in other research that may potentially interfere with SLATE endpoint(s)
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Ohio Health Research Institute Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Northwell Health Coordinator of this site? Confirm its status | Great Neck | United States | Unknown status |
| The University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Unknown status |
| University of Louisville Hospital Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Rutgers University - Robert Wood Johnson Medical School Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Hoag Memorial Hospital Presbyterian Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Oregon Health & University Science Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| University of Washington Harborview Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Wake Forest Baptist Health Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.