Clinical Trials


SURPASS Study: HF10 Therapy using Surgical Leads
The purpose of this prospective observational study is to assess the clinical performance of HF10 therapy delivered to the spinal cord through SURPASS™ surgical leads in subjects with chronic, intractable, back and/or leg pain of neuropathic origin. Following device activation, participants complete questionnaires to provide feedback on their pain, quality of life, disability, health status, satisfaction and work status.

Principle investigator: George Mandybur, MD
Trial Sponsor: Nevro Corp
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RENEW Study: HF10 Therapy in Patients who Previously Failed Traditional Spinal Cord Stimulation (SCS)
The purpose of the study is to assess the effectiveness of HF10 therapy delivered to the spinal cord in subjects with chronic, intractable, neuropathic pain of the trunk and/or limbs and who have also previously failed treatment with a traditional SCS system including dorsal root ganglion (DRG) stimulation (either trial or permanent implant). This is a data collection study where outcomes will be assessed via standardized questionnaires.

Principle investigators: Marc Orlando, MD, George Mandybur, MD
Trial Sponsor: Nevro Corp

Framing Eighteen Coils in Cerebral Aneurysms Trial (FEAT)
The purpose of this study is to compare angiographic outcomes in patients receiving 0.014-0.0155” platinum framing and filling coils followed by further aneurysm filling and finishing with less than 0.014” bare platinum coils (as deemed appropriate by the treating physician), versus those treated solely with coils less than 0.014”.

Principle investigator: Andrew Ringer, MD
Trial Sponsor: Vanderbilt University Medical Center
Financial Sponsor: Stryker (Natick, MA)

INTREPID Study for Deep Brain Stimulation
The purpose of this study is to evaluate the safety and effectiveness of the Vercise™ Deep Brain Stimulation (DBS) system as a therapy for reducing some of the symptoms associated with Parkinson’s disease (PD) that are not adequately controlled with medication.

Principal investigator: George Mandybur, MD
Sponsor: Boston Scientific Corporation

Invasive and Non-Invasive Monitoring of Spreading Depolarization by ElectroCorticography in Trauma and Stroke (INSPECT)
The aim of this study is to investigate methods of recording spreading depolarizations in non-surgical patients with acute brain injury.

Principal investigator: Jed Hartings, PhD
Sponsor: Investigator initiated

Closed trials or in follow-up

  • Minimally Invasive Surgery + rt-PA for ICH Evacuation (MISTIE III)
  • CREST-2
  • The EVICEL® Neurosurgery Phase III Study
  • Cancer Genome Atlas Patient Enrollment and Specimen Qualification Criteria Grade II-IV Gliomas
  • Rindopepimut/GM-CSF with Temozolomide for EGFRvIII-positive Glioblastoma
  • Dasatinib or Placebo Combined with Chemoradiotherapy for Glioblastoma
  • First-in-Human Study Evaluating AMG 595 in Subjects with Recurrent Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII
  • EDGE-NEWTON: Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage
  • Condition of Approval Study for the Treatment of Lumbar Spinal Stenosis with X-STOP® PEEK IPD® in Moderately Symptomatic Patients
  • Deep Brain Stimulation (DBS) Long Term Follow-Up
    CLEAR III (Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage) Phase III
  • The Injury and Traumatic Stress (INTRuST) Consortium Neuroimagin Acquisition and Archival
  • The Injury and Traumatic Stress (INTRuST) Consortium Biorepository
  • Acoustic Neuromas: Subtotal Resection & Radiosurgery
  • Chiari Malformation Study
  • RAMP: Prospective, Randomized, Multicenter Clinical Study Comparing Axial Lumbar Interbody Fusion (AxiaLIF®) and Transforaminal Lumbar Interbody Fusion (TLIF) Spinal Procedures
  • Brain Tissue Oxygen Monitoring in Traumatic Brain Injury (BOOST II)
  • Spreading Depression in Brain Trauma (COSBID-TBI)
  • CREATE – Cognitive Remediation after Traumatic Exposure Trial
  • Adherus™ Dural Sealant in Cranial Procedures
  • Monitoring of Delayed Ischemia after Subarachnoid Hemorrhage
  • ICH Removal: Minimally Invasive Surgery + rt-PA (MISTIE)
  • Stenting versus Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS)
  • Angio-Seal™ Vascular Closure Device Following Interventional Radiology Procedures
  • PRET: Patients Prone to Recurrence after Endovascular Treatment
  • Target Imaging for Assistance in Treatment of Parkinson's
  • SLV334 in Traumatic Brain Injury
  • Clazosentan in Aneurysmal Subarachnoid Hemorrhage (CONSCIOUS-3)
  • Randomized Evaluation of Carotid Occlusion and Neurocognition (RECON)
  • Carotid Occlusion Surgery Study (COSS)
  • Clazosentan in Aneurysmal Subarachnoid Hemorrhage
  • INFUSE® Bone Graft for Spine Fusion
  • Libra™ Deep Brain Stimulator for Parkinson's Disease
  • Duragen Plus to Minimize Adhesions after Lumbar Discectomy
  • Gliadel Wafers & Permanent I-125 Seeds for Glioblastoma
  • Biomarkers for Subarachnoid Induced Cerebral Vasospasm
  • IVH Removal: Intraventricular rt-PA
  • Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST)
  • Comparison of Dura Sealants for Cranial Surgery
  • New Spinal Sealant for Dura Repair
  • Eon™ Spinal Cord Stimulator for Chronic Back & Leg Pain
  • Prevention of Disability after Spinal Cord Injury (Cethrin)
  • Prevention of Seizures after Brain Injury
  • Near-infrared Spectroscopy to Detect Bleeding in the Brain
  • Brain Stimulation for Arm/Hand Weakness After a Stroke
  • Assessment of Surgery for Cervical Spondylotic Myelopathy
  • Lumbar Stabilization using the AxiaLif system
  • Evaluation of the PathFinder™ System for Pedicle Screw Insertion
  • Evaluation of the CODA Expandable Fusion Cage
  • FlexiCore™ Artificial Disc for the Treatment of Discogenic Pain
  • ChillerStrip™ Hypothermia System for Aneurysm Surgery
  • Safety and Tolerability of DTI-015 in Patients with Recurrent GBM
  • Hemicraniectomy and Durotomy Upon Deterioration from Infarction Related Swelling (HeADDFIRST)
  • Evaluation of ForSite Device to Measure Pupillary Size
  • National Acute Brain Injury Study: Hypothermia II
  • Prevention of Vasospasm & New Infarction after Aneurysmal SAH Following Administration of Clazosentan
  • Evaluation of a Single IV Dose of Dexanabinol in Patients Suffering from Severe TBI
  • Procrit® (Epoetin Alfa) Administered Perioperatively Versus Standard of Care in Blood Conservation in Subjects Undergoing Major Elective Spinal Surgery
  • DuraSeal™ System as an Adjunct to Sutured Dural Repair During Cranial Surgery

Humanitarian Use Devices

Wingspan™ Stent for Blocked Brain Arteries
The purpose of this study is to monitor the effectiveness of the Wingspan Stent System to open arteries in the brain that have become blocked by a clot or narrowed by plaque.

Principal investigator: Andrew Ringer, MD

Neuroform™ Stent for Wide-neck Aneurysms
The purpose of this study is to monitor the effectiveness of the Neuroform Stent in treating wide-neck aneurysms in the brain.

Principal investigator: Andrew Ringer, MD

Onyx Liquid Embolic System HD-500
The purpose of this study is to monitor the effectiveness of the Onyx Liquid Embolic System in treating aneurysms in the brain.

Principal investigator: Andrew Ringer, MD

CORDIS ENTERPRISE™ Vascular Reconstruction Device & Delivery System
The purpose of this study is to monitor the effectiveness of the Cordis Enterprise Device in treating aneurysms in the brain.

Principal investigator: Andrew Ringer, MD

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