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Clinical Studies


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  • A Feasibility Study to Evaluate Safety and Initial Effectiveness of MR-Guided Focused Ultrasound Ablation Therapy in the Treatment of Focal Epilepsy (EP001) Rochester, Minn. The purpose of this study is to evaluate the feasibility, safety, and initial effectiveness of ExAblate thermal ablation of a subcortical focal epileptic target area in the brain of patients suffering from medication-refractory epilepsy, using the ExAblate transcranial system to produce multiple sonications targeted in the lesion of interest. The investigators will establish the feasibility and collect data to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its full clinical efficacy.
  • A Phase 3 Multicenter Study of Gleolan (Aminolevulinic Acid Hydrochloride) to Enhance Visualization of Tumor in Patients with Newly Diagnosed or Recurrent Meningiomas Scottsdale/Phoenix, Ariz., Rochester, Minn.

    The purpose of this study is to investigate  the safety, diagnostic performance, and clinical  usefulness of  the imaging  agent Gleolan™ (Aminolevulinic  Acid Hydrochloride, ALA HCl, ALA, 5-ALA), an orally administered imaging agent for the real-time detection and visualization of meningiomas during tumor resection surgery. ALA is a prodrug that is metabolized  intracellularly  to  form  the  fluorescent  molecule  Protoporphyrin  IX  (PpIX). 

  • Intraoperative Non-invasive Eye Movement Monitoring Rochester, Minn.

    For procedures involving proximity to the nerves responsible for eye movement, the need to monitor eye movement exists. The current solution is to place needles in the muscles surrounding the eye. The Investigators have invented a non-invasive electrode and software designed to monitor eye movements non-invasively. The electrode is placed on the skin on the corner of the eye and using the natural dipole of the eye, detects the horizontal and vertical movements of the eye. The Investigators would like to prove efficacy compared to the standard monitoring.

  • Polyimide Microelectrode for Intraoperative Electrocorticography Rochester, Minn.

    This research study will investigate a new recording electrode that will record brain activity during surgery. This electrode is being tested for efficacy, and may eventually replace the current electrodes used for this purpose. The goal is to record brain activity in a region of the brain that is already being removed to treat epilepsy.