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Clinical Studies
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Stereo-EEG Investigation of the Thalamus
Rochester, Minn.
The purpose of this study is to assess the thalamus area of the brain using stereotactic electroencephalography (an EEG with deep electrode placement inside the brain) to better understand its role in the starting and spreading of epileptic seizure activity.
Closed for Enrollment
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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.
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A Phase 3 Multicenter Study of Gleolan (Aminolevulinic Acid Hydrochloride) to Enhance Visualization of Tumor in Patients with Newly Diagnosed or Recurrent Meningiomas
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
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).
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A Pilot Study of Endoscope-assisted, Minimally-invasive Cortical Access System (MICAS) for Chronic Subdural Evacuation
Rochester, Minn.
The purpose of this study is to evaluate a less-invasive alternative to the currently available method of removing aging blood in the subdural space.
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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.
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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.
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Randomized, Two-arm, Multicenter Study to Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery - ENCASE II (ENCASE II)
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to clinically assess the safety and effectiveness of LIQOSEAL® as a means of reducing intra-, as well as post-operative, CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure to show noninferiority compared to a control group.
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RNS® System Responsive Thalamic Stimulation for Primary Generalized Seizures (NAUTILUS) Study (NAUTILUS)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to demonstrate that the RNS® System for thalamic stimulation is safe and effective as an adjunctive therapy for the reduction of primary generalized seizures in individuals 12 years of age or older who have drug-resistant idiopathic generalized epilepsy.
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Stereotactic Laser Ablation for Temporal Lobe Epilepsy (SLATE)
Rochester, Minn.
The study is designed to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for mesial temporal epilepsy (MTLE).
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