Clinical Trials

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.

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.

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.

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.

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.

The goal of this study is to investigate the feasibility of successfully obtaining intra-operative OCT imaging and data during standard brain surgery.

The purpose of this study is to understand how electrical stimulation of the brain can modulate and suppress interictal epileptiform activity as a step on the path to developing new therapies for epilepsy.

The purpose of this study is to determine whether transverse/sigmoid sinus junction stenting reduces the risk of recurrent cerebrospinal fluid (CSF) leak in patients with idiopathic intracranial hypertension presenting with CSF leak.

The purpose of this study is to determine return to baseline (RTB) period after an elective craniotomy procedure using the ImPACT testing assessment.

The purpose of this study is to combine MRI images with histologic and genetic analysis of cancer (from blood and tissue samples) to improve the overall accuracy of diagnosis and effectiveness of cancer treatment.