Stereotactic Laser Ablation for Temporal Lobe Epilepsy (SLATE)

What we are studying

The purpose of the study is to learn more about a device called the Visualase Thermal Therapy System (Visualase system) and find out if using Visualase is safe and effective for the treatment of people with intractable mesial temporal lobe epilepsy (MTLE). The study will include approximately 120 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.

Who is Eligible

• Genders:
  • Men
  • Women
• Races:
  • White
  • African American
  • Asian
  • American Indian or Alaska Native
  • Native Hawaiian or Pacific Islander
  • Other
• All Ethnicities
• Ages 18+

Eligibility Criteria

• Must have:
  • History of drug-resistant mesial temporal lobe epilepsy (MTLE)
• 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 Cannot have:
  • Pregnancy
• Progressive brain lesions and/or tumors not associated with epileptic disease state
• History of previous intracranial surgery for treatment of epileptic seizures
• IQ < 70
• Dementia or other progressive neurological disease
• Allergy to gadolinium

What is involved

• 3 MRIs (preprocedure
• During procedure and postprocedure)
• 6 visits
• Questionnaires
• Neuropsychological assessments
• Neurological exam
• Seizure diary

Compensation

$150.00 for the Baseline Visit, $75.00 each for Follow-up Visits 1 and 2 and $150.00 each for Follow-up Visits 3 and 4

Contact Information

Study Coordinator

Jessica Dimos

Email

jdimos@wakehealth.edu

Phone

336-716-8694

Principal Investigator

Gautam Popli, MD