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• Investigation of Latent Visual-Tactile Agnosia in Mild to Moderate Stroke Patients

  Primary Investigator(s):

  Matthew C. Cowperthwaite, Ph.D.

  Timothoy Schallert, Ph.D.

   

  Purpose:

  To assess undetected visual-tactile agnosia impairments in the mild to moderate stroke population.  Secondary purpose is to review imaging diagnostics on same population to determine effect of location and severity of stroke in producing visual-tactile agnosia deficit.

   

  Eligibility:

  Subjects 18 years or older;  ability to be randomized within 24 hour window; positive radiographic findings of stroke on imaging; NIHSS total score < 6; mRS < or equal to 3.

   

  Treatment:

  Randomized trial of 300, 200 mild to moderate stroke subjects and 100 control.  All subjects will undergo one of four study groups asking subjects to retrieve objects of various shapes, having to determine those objects by touch alone.

   

  Status:

  Open

   

  Study Coordinator - Contact Information

  Kaelyn Kappeler, CCRC, CCRP 

  Kaelyn.kappeler@stdavids.com

• Efficacy of Ventriculosinus Shunt for Treatment of Hydrocephalus

  Primary Investigator(s)

  Mark Burnett, M.D.
  Mike Webb, M.D. 
  Kit Fox, M.D.

   

  Purpose:

  To assess the efficacy of the ventriculosinus (VS) shunt within adult hydrocephalus population for short-term neurological symptom resolution and to compare the VS shunt complication and revision rate against current cerebrospinal fluid shunt study data.

   

  Eligibility:

  Subjects 18 years or older; findings of at least one neurological impairment that can be monitored for improvement (i.e. gait disturbance, cognition, urinary symptoms); minimum duration of symptoms of at least 1 month, progression over time, and no other neurological, psychiatric or general medical conditions that are sufficient to explain the presenting symptoms; MRI or CT performed after onset of symptoms must show evidence of ventricular enlargement not entirely attributable to cerebral atrophy or congenital enlargement.

  Treatment:

  10 subjects who are undergoing neurosurgical cerebrospinal fluid shunt procedure at St. David’s Medical Center for the treatment of hydrocephalus will receive the ventriculosinus revised cerebrospinal shunt.

  Status:

  Open

   

  Study Coordinator: Kaelyn Kappeler, CCRC, CCRP
  Kaelyn.Kappeler@stdavids.com

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

  Primary Investigator:

  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

   

  Study Coordinator - Contact Information

  Kaelyn Kappeler, CCRC, CCRP

  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: 

  Open

   

  Study Coordinator - Contact Information

  Kaelyn Kappeler, CCRC, CCRP

  Kaelyn.kappeler@stdavids.com

• 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

  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

  Completed
  
  

  Study Coordinator

  Kaelyn Kappeler, CCRC, CCRP
  
  

  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:

  Closed

   

  Study Coordinator - Contact Information

  Kaelyn Kappeler, CCRC, CCRP
  Kaelyn.Kappeler@stdavids.com

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• JCV Antibody Program in Patients with Relapsing Multiple Sclerosis Receiving or Considering Treatment with Tysabri: STRATIFY-1

  Primary Investigator

  Edward Fox, M.D.

   

  Purpose

  The purpose of this study is to define the prevalence of Serum JC Antibody in relapsing MS patients receiving Tysabri or being considered for such treatment.

   

  Eligibility

  Patients with relapsing MS receiving commercial Tysabri and patients being considered for such treatment. Those patients participating in any other Tysabri clinical trial or study sponsored by Biogen Idec or Elan may not participate in this study.

   

  Primary Outcome Measures:

  Define the prevalence of serum JC virus (JCV) antibody in patients with relapsing Multiple Sclerosis receiving or considering treatment with Tysabri. Confirm the false negative rate for the serum JCV antibody assay.

   

  Secondary Outcome Measures:

  Analytically validate the JCV antibody assay in plasma matrix and determine changes in JCV antibody status over time.

   

  Status

  Open

   

  Study Coordinator - Contact Information

  Lori Mayer, RN, MSCN, CCRP
  Ph: 512-218-1222
  Email: lorimayer@sbcglobal.net

• JCV Antibody Program in Patients with Relapsing Multiple Sclerosis Receiving or Considering Treatment with Tysabri: STRATIFY-2

  Principal Investigator:

  Edward Fox, M.D.

   

  Purpose:

  The purpose of this study is to define the sero prevalence of JCV Antibody in the MS population and potentially stratify patients into lower or higher risk for developing PML based on antibody status.

   

  Eligibility:

  Patients with relapsing MS receiving commercial Tysabri and patients being considered for such treatment. Those patients participating in any other Tysabri clinical trial or study sponsored by Biogen Idec or Elan may not participate in this study.

   

  Primary Outcome Measures:

  Correlation of JCV Antibody positivity and development of PML.

   

  Secondary Outcome Measures:

  Define the sero prevalence of JCV Antibody in this US representative sample of MS patients.

   

  Status:

  Open

   

  Study Coordinator - Contact Information

  Lori Mayer, RN, MSCN, CCRP
  Ph: 512-218-1222
  Email: lorimayer@sbcglobal.net 

• Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)

  Principal Investigator:

  Edward Fox, M.D.

   

  Purpose:

  The purpose of this study is to explore alternative routes of administration for natalizumab.

   

  Eligibility:

  Aged 18 - 65 years-old, for arms 1-4 diagnosis of SPMS; arms 5-6 diagnosis of relapsing forms of MS; no past history of receiving natalizumab. Exclusive criteria: for arms 1-4, diagnosis of primary progressive MS or relapsing-remitting MS; for arms 5-6, diagnosis of primary progressive MS or secondary progressive MS without the occurrence of relapses.

   

  Primary Outcome Measures:

  PK, PD

   

  Secondary Outcome Measures:

  Safety and efficacy

   

  Status

  Open

   

  Study Coordinator - Contact Information:

  Lori Mayer, RN, MSCN, CCRP
  Ph: 512-218-1222
  Email: lorimayer@sbcglobal.net

• TYSABRI Global Observational Program in Safety (TYGRIS)

  Principal Investigator:

  Eward Fox, M.D.

   

  Purpose:

  The purpose of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious events in patients with multiple sclerosis (MS) treated with TYSABRI (natalizumab).

   

  Eligibility:

  MS patients in the US and Canada receiving TYSABRI under standard clinical care for less than or equal to 3 infusions are eligible to participate in TYGRIS.

   

  Primary Outcome Measures:

  To determine the incidence and pattern of serious infections, malignancies, and other serious adverse events (SAEs) in patients with Multiple Sclerosis (MS) treated with Tysabri.

   

  Status:

  Open

   

  Study Coordinator - Contact Information:

  Lori Mayer, RN, MSCN, CCRP
  Ph: 512-218-1222
  Email: lorimayer@sbcglobal.net

• Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis (SURPASS)

  Principal Investigator:

  Edward Fox, M.D.

   

  Purpose:

  This study will examine subjects with relapsing-remitting MS that has been active within the past 12 months, that are being treated with either Copaxone® (glatiramer acetate) or Rebif® (interferon β-1a). This study aims to measure the effect of switching to Tysabri compared to receiving Copaxone (glatiramer acetate) or Rebig (interferon β-1a) in subject with Relapsing Remitting Multiple Sclerosis.  The results of clinical tests and evaluations and brain magnetic resonance imaging (MRI) scans will be compared.

   

  Eligibility:

  Extensive inclusion/exclusion criteria.  Please contact Study Coordinator for further information.

   

  Primary Outcome Measures:

  The primary endpoint in this study is the annualized relapse rate in subjects with relapsing remitting multiple sclerosis (RRMS).

   

  Secondary Outcome Measures:

  Change from baseline to 48 weeks in T2 lesion volume; Proportion of subjects free of disease activity; change from baseline to 48 weeks in physical impact score of multiple sclerosis impact scale.

   

  Status:

  Open

   

  Study Coordinator - Contact Information

  Lori Mayer, RN, MSCN, CCRP
  Ph: 512-218-1222
  Email: lorimayer@sbcglobal.net

• Comarison of Campath and Rebif Treatment on Cognition in Multiple Sclerosis (MS)

  Principal Investigator:

  Edward Fox, M.D.

   

  Purpose:

  The main purpose of this research study is to investigate how well two medicines Campath® (alemtuzumab) and Rebif ® (interferon β -1a) work in treating MS-related cognitive programs (e.g., attention, memory, speed of thinking).  Participants enrolled will be assessed prior to their first study-related medication dose and re-assessed throughout treatment.  It is expected that participants taking Campath® will demonstrate relative stability in cognitive funtioning relative to those taking Rebif®.  Specifically, the cognitive performance of Rebif® participants will decline somewhat over time, but the cognitive performance of Campath® participants will remain stable.

   

  Eligibility:

  Inclusion/exclusion criteria extensive.  Please contact the Study Coordinator for further details.

   

  Status:

  Open

   

  Study Coordinator - Contact Information

  Lori Mayer, RN, MSCN, CCRP
  Ph: 512-218-1222
  Email: lorimayer@sbcglobal.net

• Phase III Study with Teriflunomide Versus Placebo in Patients with First Clinical Symptom of Multiple Sclerosis (TOPIC)

  Principal Investigator:

  Edward Fox, M.D.

   

  Purpose:

  The primary objective is to demonstrate the effect of teriflunomide (14mg/day and 7mg/day) compared to placebo for reducing conversion of patients presented with their first clinical episode consistent with Multiple Sclerosis (MS) to clinically definite MS.

   

  Eligibility:

  Patients with a first acute or subacute, well-defined neurological event consistent with demyelination (i.e. ooptic neuritis confirmed by an ophthalmologist, spine cord syndrome, brainstem/cerebellar syndromes); onset of MS symptoms occurring within 60 days of randomization; screening MRI with 2 or more T2 lesions at least 3mm in diameter that are characteristic of MS.  Exclusion criteria includes: patient with clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease; patients with significant imparied bone marrow function; pregnant or nursing women; use of cladribine, mitoxantrone or other immunosuppressant agents such as axathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment; any known condition or circumstances that would prevent in the investigator's opinion compliance or completion of the study. 

   

  Primary Outcome Measures:

  Conversion to clinically definite MS as defined by the occurrence of a relapse.

   

  Secondary Outcome Measures:

  Conversion to definite MS as demonstrated by the dissemination of cerebral Magnetic Resonance Imaging (MRI) lesions in time; annualized relapse reate; burden of disease; disability progression as assessed by the Kurtzke Expanded Disability Status Scale (EDSS); subject reported fatigue as assessed by the Fatigue Impact Scale (FIS).

   

  Status:

  Open

   

  Study Coordinator - Contact Information

  Lori Mayer, RN, MSCN, CCRP
  Ph: 512-218-1222
  Email: lorimayer@sbcglobal.net

• A Safety and Efficacy Extension Study of ONO-4641 in Patients with Relapsing-Remitting Multiple Sclerosis (DreaMS)

  Principal Investigator:

  Edward Fox, M.D.

   

  Purpose:

  The purpose of this active-drug Extension Study is to evaluate the continuing safety and efficacy of ONO-4641 in patients with relapsing-remitting Multiple Sclerosis (RRMS) in patients who have completed an initial 26-week study. 

   

  Eligibility:

  Aged 18 - 55 years old; completed 26-weeks of double-blind phase of Study ONO-4641POU006.  Exclusion criteria includes the presence of any dermatological abnormalities during Study ONO-4641POU006 that could increase the risk of the patient developing a skin cancer.

   

  Primary Outcome Measures:

  The long-term safety and tolerability of ONO-4641 using vital signs, pulmonary function tests, ECGs, dermatological and ophthalmologic examinations.

   

  Secondary Outcome Measures:

  The number of Gd-enhanced lesions obtained by MRI; lesion volume obtained by MRI; brain volume obtained by MRI.

   

  Status:

  Open

   

  Study Coordinator - Contact Information:

  Lori Mayer, RN, MSCN, CCRP
  Ph: 512-218-1222
  Email: lorimayer@sbcglobal.net

• A 6-month, Randomized, Open-label, Patient Outcomes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5mg/day Vs. Comparator in Patients with Relapsing Forms of Multiple Sclerosis (EPOC)

  Principal Investigator:

  Edward Fox, M.D.

   

  Purpose:

  The purpose of this study is to evaluate patient-reported outcomes, physician assessment of a change as well as safety and tolerability in patients with Relapsing Forms of Multiple Sclerosis on previous Disease Modifying Therapy (DMT) who are randomized to one of two treatment arms: fingolimod vs. standard of care DMT.

   

  Eligibility:

  Patients with Relapsing-Remitting MS; EDSS 0-5.5; treatment with MS DMT for 6 months; Fingolimod naive.  Exclusion criteria includes those patients with immune system diseases other than MS; macular edema; hx of selected prior infections and criteria for immunizations; hx of selected immune system treatments and/or medications; selected cardiovascular, pulmonary, or hepatic conditions; selected abnormal laboratory values; pregnant or nursing women. 

   

  Primary Outcome Measures:

  Treatment Satisfaction Questionnaire for Medication

   

  Secondary Outcome Measures:

  Safety and tolerability immediately after a change in Disease Modifying Therapy (DMT) during 6 months of treatment with fingolimod vs. DMT standard of care; change in patient-reported Activities of Daily Living (ADL) using the Multiple Sclerosis Activities Scale; change in pateint-reported fatigue using the Fatigue Severity Scale (FSS); changes in patient-reported effectiveness, side effects and convenience subscales using the TSQM v1.4; change in patient-reported depression using the Beck Depression Inventory (BDI-II)

   

  Status:

  Open

   

  Study Coordinator - Contact Information:

  Lori Mayer, RN, MSCN, CCRP
  Ph: 512-218-1222
  Email: lorimayer@sbcglobal.net

• An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

  Principal Investigator:

  Edward Fox, M.D.

   

  Purpose:

  The purposes of this study are:

  1. To examine the long term safety and efficacy of alemtuzumab treatment in patients who received alematuzumab as their study treatment in one of the prior studies.

  2. To examien the safety and efficacy of initial alemtuzumab treatment in this study for patients who received Rebif® (interferon beta-1a) as their study treatment in one of the prior studies.

  3. To determine if and when further alemtuzumab treatment is needed, and the safety and efficacy of this "as needed" treatment.  This applies both to patients who received alemtuzumab for the first time in one of the prior studies or for the first time in this extension study.

   

  Eligibility:

  Extensive inclusion/exclusion criteria.  Please contact the Study Coordinator for further details.

   

  Primary Outcome Measures:

  Time to Sustained Accumulation of Disability (SAD); relapse rate.

   

  Secondary Outcome Measures:

  Time to sustained reduction in disability (SRD) as measured by the EDSS (Expanded Disability Status Scale); change over time in EDSS scores; change over time in MRI findings.

   

  Status:

  Open

   

  Study Coordinator - Contact Information

  Lori Mayer, RN, MSCN, CCRP
  Ph: 512-218-1222
  Email: lorimayer@sbcglobal.net

• Evaluation of Two Glatirmer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients (ENCORE)

  Principal Investigator:

  Edward Fox, M.D.

   

  Purpose:

  An open-label, multicenter study evaluating patient injection satisfaction with two formulations of glatiramer acetate (GA) using Autoject 2 as the subcutaneous injection delivery method.

   

  Eligibility:

  Exstensive inclusion/exclusion criteria.  Please contact Study Coordinator for further details.

   

  Primary Outcome Measures:

  Difference in composite mean scores as measured by the Satisfaction with Injection Experience question.

   

  Secondary Outcome Measures:

  Categorical preference reating as measured by the injection Experience Preference questions.

   

  Status:

  Open

   

  Study Coordinator - Contact Information

  Lori Mayer, RN, MSCN, CCRP
  Ph: 512-218-1222
  Email: lorimayer@sbcglobal.net

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