Neurosurgery

Below are current clinical trials.

Filter this list of studies by location, status and more.

1. A Study to Evaluate fMRI of Active Deep Brain Stimulation in Epilepsy

   Jacksonville, Fla.

   The purpose of this study is to to use functional imaging to study the mechanisms of anterior thalamic nucleus (ANT) Deep Brain Stimulation (DBS).

2. A Study to Evaluate the Safety and Effectiveness of Adherus™ AutoSpray and Adherus™ AutoSpray ET Dural Sealant

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this study is to evaluate the safety and effectiveness of Adherus Dural Sealant when used in conjunction with standard methods of dural repair in spinal procedures. This trial uses the commercially available DuraSeal Exact (P080013b) as an active control. The trial is designed to demonstrate non-inferiority of Adherus Dural Sealant to DuraSeal Exact.
   Subjects who have consented to participate in this study prior to undergoing spinal surgery and experience a durotomy, will be considered for study enrollment.
    

3. Posterior Fossa Decompression with or without Duraplasty for Chiari Type I Malformation with Syringomyelia

   Rochester, Minn.

   The purpose of this study is to determine whether a posterior fossa decompression or a posterior fossa decompression with duraplasty results in better patient outcomes with fewer complications and improved quality of life in those who have Chiari malformation type I and syringomyelia.

4. Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial - Hemodynamics (CREST-H)

   Rochester, Minn., Jacksonville, Fla.

   We aim to determine whether cognitive impairment attributable to cerebral hemodynamic impairment in patients with high-grade asymptomatic carotid artery stenosis is reversible with restoration of flow. To accomplish this aim CREST-H will add on to the NINDS-sponsored CREST-2 trial (parallel, outcome-blinded Phase 3 clinical trials for patients with asymptomatic high-grade carotid artery stenosis which will compare carotid endarterectomy plus intensive medical management (IMM) versus IMM alone (n=1,240), and carotid artery stenting plus IMM versus IMM alone (n=1,240) to prevent stroke and death). CREST-H addresses the intriguing question of whether cognitive impairment can be reversed when it arises from abnormal cerebral hemodynamic perfusion in a hemodynamically impaired subset of the CREST-2 -randomized patients. We will enroll 500 patients from CREST-2, all of whom receive cognitive assessments at baseline and yearly thereafter. We anticipate identifying 100 patients with hemodynamic impairment as measured by an inter-hemispheral MRI perfusion "time to peak" (TTP) delay on the side of stenosis. Among those who are found to be hemodynamically impaired and have baseline cognitive impairment, the cognitive batteries at baseline and at 1 year will determine if those with flow failure who are randomized to a revascularization arm in CREST-2 will have better cognitive outcomes than those in the medical-only arm compared with this treatment difference for those who have no flow failure. We hypothesize that hemodynamically significant "asymptomatic" carotid disease may represent one of the few examples of treatable causes of cognitive impairment. If cognitive decline can be reversed in these patients, then we will have established a new indication for carotid revascularization independent of the risk of recurrent stroke.

5. A Study to Evaluate Endoscopic Endonasal Skull Base Surgery and Pituitary Surgery Quality of Life

   Rochester, Minn.

   The objectives of this study are to:

   • • Measure the short and long-term overall and nasal-specific quality of life (QOL) impact of patients undergoing Endoscopic Endonasal Skull Base Surgery (EESBS) for pituitary and sellar lesions.
     • Determine the relative difference in QOL impact of EESBS for patients undergoing surgery for functional and nonfunctional pituitary adenomas.
     • Generate baseline data to development and validate a site-specific endoscopic-specific comprehensive QOL for EESBS.
     • Particular tumors of interest include pituitary tumors, Rathke’s cleft cysts, craniopharyngiomas, clival chordomas and chondrosarcomas.
     • Specific QOL aims focus on olfaction (sense of smell), gustation (sense of taste) and nasal function.

    

    

6. A Study to Assess Neuroinflammation in Epileptic Tissue Immediately Prior to Surgical Resection Using Intraoperative Brain Microdialysis

   Rochester, Minn.

   The purpose of this study is to measure the space and time characteristics of inflammatory mediator release in response to induced epileptiform activity in ASD-resistant patients.

7. A Study to Evaluate Awake vs. Asleep Spine Surgery

   Jacksonville, Fla.

   Patients undergoing spine lumbar surgery will be asked to perform short exams/questionnaires aimed at determining cognitive function, quality of life, health outcomes twice post surgery with a baseline performance prior to surgery.

8. A Study to Assess Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval (EPAS)

   Rochester, Minn.

   The purpose of this post-approval study is to further evaluate the long-term safety and effectiveness of Medtronic DBS therapy for epilepsy on seizure reduction in newly implanted participants through 3 years of follow-up in different geographic populations.

9. Primary Tumor Research and Outcome Network (PTRON) Registry

   Rochester, Minn.

   The purpose of this registry is to collect clinical, diagnostic, and therapeutic data specific for primary spinal column tumor patients, and evaluate it to understand the predictive factors which influence survival, local recurrence, adverse events, perioperative morbidity, and health related quality of life.

10. A Study to Evaluate Advanced Development of Desorption Electrospray Ionization Mass Spectrometry for Intraoperative Molecular Diagnosis of Brain Cancer

    Jacksonville, Fla.

    The purpose of this study is to explore the translational abilities of desorption electrospray ionization mass spectrometry (DESI-MS) as intraoperative diagnostic tool to identify cancerous versus noncancerous tissue and estimate the percentage of tumor infiltration in tissue biopsies, by monitoring depletion of N-acetylaspartate (NAA) and aberrations of the phospholipid signature of neurological tissue; and to identify the presence of IDH mutations by monitoring the 2-hydroxyglutarate (2HG) and, therefore, differentiate between IDH-mutant and wild-type gliomas.