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Stereotactic Laser Ablation for Temporal Lobe Epilepsy (SLATE Trial)
SLATE Trial Summary
This trial will test whether the Visualase MRI-guided laser ablation system is safe and effective for treating mesial temporal lobe epilepsy.
SLATE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSLATE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SLATE Trial Design
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Who is running the clinical trial?
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- You have ongoing abnormal brain activity on an EEG test, which shows spikes or slowing in certain areas of the brain.You are allergic to gadolinium.You have a serious mental illness or medical condition that could make the Visualase procedure unsafe or affect the tests of thinking and emotions.You have a medical device that makes it unsafe for you to have a MRI scan.You have growing brain tumors not related to epilepsy.You have had surgery on your brain in the past to treat seizures.You have seizures that start on one side of the brain or in areas other than the temporal lobe, as shown on an EEG test.You have a condition like dementia or another disease that affects your brain and gets worse over time.Your symptoms suggest that the source of the seizure is not in the temporal lobe.Your MRI shows certain types of brain lesions or changes related to epilepsy.Not following the medication requirements for seizures.You have a history of epilepsy that does not respond to medication in the part of the brain called the mesial temporal lobe.If you have a device called a vagus nerve stimulator (VNS), you must have tried it for at least 6 months and still have seizures.You have at least one specific type of seizure every month.You have symptoms of seizures or auras that are consistent with a specific type of epilepsy called MTLE.MRI shows signs of a specific type of brain damage called mesial temporal lobe sclerosis.Video brain scan shows evidence of seizures coming from one specific part of the brain, which is consistent with a certain type of epilepsy.If other tests show something different than the planned treatment for seizures.You have an IQ score below 70.
- Group 1: Treatment
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Am I eligible to be enrolled in this clinical experiment?
"For this clinical trial, 150 individuals who meet the following requirements are being accepted: a diagnosis of temporal lobe epilepsy (TLE), aged 18 to 70, failed to obtain seizure freedom with vagus nerve stimulator (VNS) for at least 6 months and experienced an average of 1 complex partial or secondarily generalized seizure per month. Additionally, they must be willing and able to remain on stable anti-epileptic drugs 12 months after Visualase procedure as well as adhere to other protocol demands."
How many sites are carrying out the research project?
"21 medical centres are participating in this trial, including University of Miami (Miami), Ohio Health Research Institute (Columbus) and the prestigious University of California, San Francisco. Additionally there are 18 other sites across the United States."
Is this study actively seeking participants at this time?
"Affirmative. The records available on clinicaltrials.gov demonstrate that this medical trial, which was created on December 1st 2016, is actively recruiting participants. 150 people are needed to be recruited from 21 different healthcare facilities."
How many participants are actively engaged in this research endeavor?
"Affirmative, clinicaltrials.gov confirms that this trial is actively recruiting participants. It was first made available on December 1st 2016 and the most recent update was posted on July 27th 2022. 150 individuals from 21 distinct research centres must be enrolled in order to complete it."
Does this research encompass individuals who are senior citizens?
"To qualify for this research, individuals must be aged between 18 and 70 years of age. Additionally, there are 103 clinical trials available to those under 18, while 158 studies target seniors above the age of 65."
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