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• A Phase I Trial of Intraoperative Optical Imaging of Brain Function

  Primary Investigator

  Douglas Fox, M.D.
  Andrew Dunn, PH.D.
  
  

  Purpose

  The purpose of this study is to collect pilot data to investigate the use of novel optical imaging techniques for multi-parameter hemodynamic mapping of brain function during surgery.
  
  

  Eligibility

  Adults planned for craniotomy surgery at St. David’s Medical Center will be included in this study. Reasons for craniotomy will include planned resection for brain tumor. The following criteria will be observed: Adults 18 years or older; location of planned resection near somatosensory cortex; possibility of intraoperative electrocortical mapping; subject able to render written informed consent. Those subjects with a hemiparesis graded 3/5 or worse or with impaired cognitive function will not be eligible.
  

  
  

  Treatment

  Phase I study to enroll 10 patients; the first 5 patients will be evaluated as to the ability of laser speckle contract imaging to image cerebral blood flow intraoperatively. Images will record changes in cerebral blood flow in response to somatosensory stimulation. The remaining 5 patients will be simultaneously imaged for hemoglobin oxygenation, blood volume, blood flow, and CMRO2 changes during somatosensory stimulation using a combined laser speckle and multi-wavelength reflectance imaging system. The general procedure will be to acquire images with a camera attached to the operating microscope after the craniotomy is performed and the somatosensory cortex is exposed and prior to surgical resection. The exposed area will be diffusely illuminated with either laser light or filtered white light and somatosensory stimulation will be achieved by median nerve stimulation.
  

  
  

  Status

  Open
  
  

  Start Date

  February 18, 2009
  
  

  Study Coordinator

  Kaelyn Kappeler
  
  

  Coordinator Contact

  Kaelyn.Kappeler@stdavids.com

• Penumbra imaging Collaborative Study (PICS)

  Primary Investigator

  Stanley Kim, M.D.
  
  

  Purpose

  This study is a prospective multi-center study of patients with acute ischemic stroke who are revascularized using the Penumbra System. The purpose of this study is to gather data on the experience of the Penumbra System and to determine if there is a correlate between the imaging-defined size of the ischemic penumbra at admission and patient outcome in patients treated by the System.
  
  

  Eligibility

  The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within 8 hours of symptom onset.
  
  

  Treatment

  Procedure begins with angiography to properly visualize the acute ischemia, then the Penumbra System is introduced, aspiration acquired and blood clot removed, followed by final angiographic examination. Patient followed post-operatively at 7 days and 90 days.
  
  

  Status

  Open
  
  

  Start Date

  April 22, 2010
  
  

  Study Coordinator

  Kaelyn Kappeler
  
  

  Coordinator Contact

  Kaelyn.Kappeler@stdavids.com

• Evaluation of Neuroplastic Changes in Patients Participating in an Enhanced Fitness Program During Post-Acute Brain Injury Rehabilitation

  Primary Investigator:

  Jim Misko, PsyD

  Purpose:

  Investigates the functional and biological impact of improved cardiovascular fitness on the traumatic brain injury survivor during the course of standard post-acute treatment.

  Eligibility:

  Documented period LOC or period of post-traumatic amnesia of at least 24 hours or presence of positive CT or MRI findings of trauma-related injury; hx of TBI six months or more at time of study entry; subject age 18 – 50; subject R-handed; estimated IQ of 70 or higher. TBI involving foreign body penetration will be excluded.

  Treatment:

  Randomized assignment of 30 subjects to extra 45 minute aerobic fitness program; 30 subjects relegated to physical therapy standard of care with no additional aerobic fitness program to serve as control group. Subjects within aerobic fitness program will have set exercise regimen and have HRs documented daily pre-, mi-way and post- exercise session.

  Status:

  Enrolling soon

  Start Date:

  TBA

  Study Coordinator:

  Kaelyn Kappeler

  Coordinator Contact:

  Kaelyn.kappeler@stdavids.com

• Identification of Novel Genetic Markers Associated with Phantom Pains Following Limb Amputation

  Primary Investigator(s):

  Matthew C. Cowperthwaite, Ph.D.

  Purpose:

  To identify novel, inheritable genetic markers that are associated with an individual’s susceptibility to phantom limb pain (PLP) following limb amputation.

  Eligibility:

  Subjects 18 years or older; limb amputation performed within last six months; able to render written informed consent; no history of neuropathic pain or chronic generalized pain; no history of chemical or other type of burn or cancer.

  Treatment:

  Randomized trial of 100 patients; 50 subjects with c/o PLP and 50 subjects with no c/o PLP. Data collection to include detailed medical history questionnaire and 1ml blood sample collected for genetic analysis.

  Status:

  Enrolling soon

  Start Date:

  TBA

  Study Coordinator:

  Kaelyn Kappeler

  Coordinator Contact:

  Kaelyn.kappeler@stdavids.com

• Center for Computational Neuroscience
• Center for Brain Tumor Genetics
  & Biology
• Stroke Research
• NeuroRehabilitation Research
• Evidence-Based Medicine
• Biomedical Device Technology