Neurosurgery

Below are current clinical trials.

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

1. Investigation of Regulatory Genes in Pathophysiology of Craniosynostosis

   Rochester, Minn.

   The purpose of this study is to collect tissue (during the initial procedure only) that is surgically removed (and routinely discarded at Mayo Clinic) from CS patients. Portions of the tissue will be embedded in plastic for histological and histomorphometric analysis. A small portion of the tissue will be used for outgrowth cultures to isolate cells. Nucleic acid and protein will be extracted from the remaining portions of the tissue and/or isolated cell lines to examine candidate genes and their role in the disease process.

2. Use of Tamsulosin to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery

   Rochester, Minn.

   Postoperative urinary retention is a frequent complication of spinal surgeries and impacts a large portion of this population which results in increased morbidity as a result of increased number of catheterizations, urinary tract infections (UTIs) and prolonged hospital stays. With the addition of Tamsulosin, the investigators would anticipate a reduction in the incidence and duration of postoperative urinary retention and therefore a reduction in morbidity related to treatment of urinary retention as well as shortened hospital stays.

3. 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).

4. A Study to Implement a Patient-Centered Pain Plan and Standardized Preoperative Pain Education for Patients Undergoing Lumbar Procedures

   Mankato, Minn.

   The purpose of this study is to develop a patient-centered pain plan and standardized preoperative pain education for patients undergoing lumbar procedures to increase postoperative pain control and patient satisfaction.

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

   Jacksonville, Fla., Rochester, Minn.

   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.

6. A Study of Positive Long-Term Functional Outcomes with Early Tracheostomy in Ventilated Stroke Patients

   Jacksonville, Fla.

   The purpose of this study is to test for the long-term outcomes in function for stroke patients who get an early tracheostomy, versus those who have prolonged orotracheal intubation. 

    

    

   Patients with severe ischemic and hemorrhagic strokes, who require mechanical ventilation, have a particularly bad prognosis. If they require long-term ventilation, their orotracheal tube needs to be, like in any other intensive care patient, replaced by a shorter tracheal tube below the larynx. This so called tracheostomy might be associated with advantages such as less demand of narcotics and pain killers, less lesions in mouth and larynx, better mouth hygiene, safer airway, more patient comfort and earlier mobilisation. The best timepoint for tracheostomy in stroke, however, is not known. Preliminary data from a pilot study of early tracheostomy in patients with hemorrhagic or ischemic stroke suggest that such patients may also have improved survival and long-term functional outcomes, but a large, multicenter clinical trial is needed to confirm these findings.

7. A Study to Understand the Patients’ Perioperative Experiences of Awake Craniotomies

   Jacksonville, Fla.

   This study seeks to understand the patient perceptions of awake craniotomies. 

8. Pembrolizumab and Standard Therapy in Treating Patients With Glioblastoma

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   This phase II trial studies the side effects and how well pembrolizumab works in combination with standard therapy in treating patients with glioblastoma. Drugs used in the chemotherapy, such as pembrolizumab and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving pembrolizumab and standard therapy comprising of temozolomide and radiation therapy may kill tumor cells.

9. A Registry for the Research of Primary Tumors of the Spine

   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 Compare HF10 Therapy Combined With CMM to CMM Alone in the Treatment of Non-Surgical Refractory Back Pain

    Scottsdale/Phoenix, Ariz.

    The purpose of this study is to document the safety, clinical effectiveness and cost-effectiveness of high-frequency SCS at 10 kHz (HF10™ Therapy) delivered through the Senza system in subjects with chronic refractory back pain (with or without leg pain) who are not considered candidates for spine surgery. This study is a multi-center, prospective, randomized study to compare the two treatment groups.