A Study to Characterize the Performance of Brain Laser (LITT) Ablation for Treating Epilepsy that is Resistant to Medical Therapy

Overview

  • Study type

    Interventional
  • Study phase

    I
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Jacksonville, Florida: 16-005426
    NCT ID: NCT02820740
    Sponsor Protocol Number: CL10054

About this study

The purpose of this study is to characterize the use of the Monteris NeuroBlate System for the performance of brain laser interstitial thermal therapy (LITT) ablation treatment of medial temporal lobe epilepsy that is resistant to medical tharapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Diagnosis of unilateral medial temporal lobe epilepsy  confirmed clinically and with either 
    • Ictal scalp recording and MRI evidence of mesial temporal sclerosis 
    • Intracranial ictal onset consistent with hippocampal origin
  • Averages 3 or more complex partial seizures (with or without secondary generalization) per month
  • Refractory to antiepileptic drugs and have failed treatment with at least 2 due to lack of effectiveness
  • Meets the criteria for a medial temporal lobe resection and is a candidate for LITT
  • 18 years or older at the time of consent

Exclusion Criteria

  • Previous diagnosis of psychogenic/non-epileptic seizures
  • Previous diagnosis of primary generalized seizures
  • IQ less than 70
  • Has an MRI-incompatible implanted electronic device or any metallic prosthesis or implant for which brain MRI is contraindicated

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

William Tatum, D.O.

Closed for enrollment

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CLS-20258811

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