Assessment of Contributions to Impaired Walking after Neurologic Injury

Date Added
January 15th, 2014
PRO Number
Pro00028941
Researcher
Chris Gregory

List of Studies


Keywords
Brain, Healthy Volunteer Studies, Muscle, Nerve, Physical Therapy, Rehabilitation Studies, Stroke
Summary

Rehabilitation interventions including resistance training, functional and task-specific therapy, and gait or locomotor training have been shown to be successful in improving motor function in individuals with neurologic disease or injury. Recent investigations conducted in our laboratory indicate that intense resistance training coupled with task-specific functional training lead to significant gains in functional motor recovery. Similarly, gait rehabilitation involving intense treadmill training and/or task-specific locomotor training has been shown to be effective in improving locomotor ability. However, the underlying neural adaptations associated with these therapeutic approaches are not well understood. Our primary goal is to understand the motor control underpinnings of neurologic rehabilitation in order to apply this knowledge to future generations of therapeutic interventions.

Institution
MUSC
Recruitment Contact
Brian Cence
843-792-2668
cence@musc.edu

A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak® Knee Stystem.

Date Added
February 18th, 2014
PRO Number
Pro00030785
Researcher
Richard Friedman

List of Studies


Keywords
Joint, Pain, Surgery
Summary

The study will collect data to further affirm the safety and effectiveness of the Optetrak® Knee System product lines. Data will be collected in order to provide post-market subjective and objective evidednce of safety and effectivness. Data may be analyzed to support future presentation and publication of the Optetrak® Knee Systems and will be made available in the event Exactech is required to provide clinical evidence of the post market outcomes of the Optetrak Knee devices.

Institution
MUSC
Recruitment Contact
Lisa Mock
843-876-2211
mockl@musc.edu

An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes

Date Added
February 18th, 2014
PRO Number
Pro00030914
Researcher
Richard Friedman

List of Studies


Keywords
Joint, Pain, Surgery
Summary

The purpose of this study is to collect and evaluate clinical and radiographic outcomes data on patients who have undergone, or will undergo, shoulder replacement surgery. Patients who receive a device from the Equinoxe® Shoulder System, manufactured and distributed by Exactech, Inc as well as patients who receive a device from another shoulder arthroplasty system may be included in this study.

Institution
MUSC
Recruitment Contact
Lisa Mock
843-876-2211
mockl@musc.edu

Repetitive TMS Modulates Dorsal Lateral Prefrontal-Ventral Medial Prefrontal Pathway to Decrease Craving in Smokers

Date Added
March 4th, 2014
PRO Number
Pro00032649
Researcher
Xingbao Li

List of Studies


Keywords
Brain, Smoking
Summary

Cigarette smoking causes significant morbidity and mortality in the United States. Smoking cessation is difficult, with the average smoker attempting to quit five times before permanent success. Moreover, the majority of smoking quit attempts result in relapse. Brain stimulation for smoke cessation is an exciting new area that builds on advancing neuroscience knowledge concerning the functional neurocircuitry of addiction. Cortical stimulation can now be performed non-invasively by transcranial magnetic stimulation (TMS). Several studies have shown that TMS can reduce cue-elicited craving in smokers. Previous research by our group has shown that a single session of 15 minutes high frequency (10 Hz) repetitive TMS (rTMS) at 100% motor threshold over the left dorsal lateral prefrontal cortex (DLPFC) can reduce cue-induced craving compared to sham TMS. However, the mechanism by which craving is reduced by rTMS is poorly understood both at behavioral and neural levels. Neuroimaging studies in nicotine dependence have revealed cue-related responses in numerous brain areas, including frontal, parietal cortices and subcortical areas. Recently functional magnetic resonance imaging (fMRI) studies by our group have shown that cue-induced craving induced brain activation in ventral medial prefrontal cortex (VMPFC), including medial frontal, orbital frontal and anterior cingulate. This Chair Research Development Fund (CRDF) pilot proposal will integrate two new techniques- TMS and fMRI to investigate DLPFC-VMPFC pathway in smokers. Using double-masked methods we hypothesize that cue-induced exposure will induce brain activity in VMPFC, and 15 minutes rTMS over DLPFC will reduce cue-induced craving through modulating DLPFC-VMPFC pathway (increased activity DLPFC and decreased activity VMPFC). In the one year of project, we plan to recruit 10 non-treatment-seeking nicotine-dependent cigarette smokers and 20 non-smoking participants, both males and females of all ethnic and racial groups between the ages of 18 and 60 to participate in the study. The participants will randomly receive two different types of brain stimulation: active rTMS or sham rTMS over the left DLPFC with a 1 week interval between treatments. MRI scans will be completed pre and post rTMS. The data from this pilot will provide the information needed for submitting a larger-scale investigation (R01) to investigate cue craving neutral pathway and develop a potential clinical applications of TMS in smoke cessation.

Institution
MUSC
Recruitment Contact
Xingbao Li
843 7925729
lixi@musc.edu

Regulation of Inflammatory T Cells and Neuroprotection by Calpain Inhibition in MS

Date Added
March 4th, 2014
PRO Number
Pro00028348
Researcher
Narendra Banik

List of Studies


Keywords
Inflammation, Multiple Sclerosis
Summary

A number of veterans suffer from multiple sclerosis (MS), a devastating and debilitating disease for which there is not cure or significant treatment. The only therapy available is immunomodulatory, but does not treat the neurodegeneration. The studies proposed in this application will develop therapeutic strategies and identify a drug that ameliorates inflammation as well as neurodegeneration in the disease. Thus, the effect of this drug will not only help veterans with MS, but will also benefit individuals with the disease in general.

Institution
MUSC
Recruitment Contact
Elizabeth Kau
789-6450
elizabeth.kau2@va.gov

Validation of computer-based saccade measures as a sensitive, reliable, and freely available biomarker for tracking subtle neurocognitive changes in Parkinson's disease

Date Added
March 28th, 2014
PRO Number
Pro00031260
Researcher
Travis Turner

List of Studies


Keywords
Parkinsons
Summary

We will ask 80 patients with Parkinson's disease, representing the full spectrum of motor and cognitive symptoms, to participate. Participation will include measurement of eye movements using two methods: the new computer-based saccade battery and the best available video-based eye-tracking equipment. The evaluation will be repeated about 30 days later. Data will be analyzed to determine whether the computer-based tasks are reliable and able to provide the same quality of information as the gold standard in eye-tracking. A comparison sample of 80 healthy older adults will also complete the behavioral saccade tests in order to establish normative data that will enable application in clinical settings.

Institution
MUSC
Recruitment Contact
Travis Turner
619-788-3079
turnertr@musc.edu

A RANDOMIZED PHASE III STUDY OF BENDAMUSTINE PLUS RITUXIMAB VERSUS IBRUTINIB PLUS RITUXIMAB VERSUS IBRUTINIB ALONE IN UNTREATED OLDER PATIENTS (≥ 65 YEARS OF AGE) WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)

Date Added
April 4th, 2014
PRO Number
Pro00033691
Researcher
Brian Hess

List of Studies


Keywords
Cancer/Leukemia
Summary

This study is for male and female patients who are 65 years of age or older who have chronic lymphocytic leukemia (CLL) that has never been treated before, and their disease has progressed to the point that therapy has been recommended. The purpose of this study is to compare the effects, good and/or bad, of the drug ibrutinib, either alone or in combination with the drug rituximab, with the standard treatment for this disease. The standard treatment is chemotherapy with the drug bendamustine in combination with the drug rituximab. The effects on the patient and their leukemia will be looked at to find out which treatment is better. Both bendamustine and rituximab are approved by the FDA to treat chronic lymphocytic leukemia (your leukemia type), but ibrutinib is considered investigational. In this study, patients will get either the drug ibrutinib alone, or ibrutinib with rituximab, or bendamustine with rituximab. If the patient is in the group that receives bendamustine with rituximab and their disease returns, they will have the option to receive ibrutinib.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer.

Date Added
April 28th, 2014
PRO Number
Pro00034803
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer/Genitourinary, Prostate
Summary

This study is for patients that have prostate cancer that has spread and are either beginning hormone therapy for the first time or have been on hormone therapy for less than 30 days. The purpose of this study is to find out what effects (good and/or bad) there are to adding the new investigational drug TAK-700 (also called orteronel) to standard hormone therapy which is used to treat prostate cancer as compared to the standard of hormone therapy alone. The combination of TAK-700 and standard hormone therapy is considered experimental.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer

Date Added
April 30th, 2014
PRO Number
Pro00034096
Researcher
Whitney Graybill

List of Studies


Keywords
Cancer/Gynecological, Women's Health
Summary

This study is for adult women who have advanced or recurrent endometrial (uterine) cancer. The purpose is to find out if the drug combination of paclitaxel, carboplatin and metformin works better than paclitaxel and carboplatin alone in treating uterine cancer.

Institution
MUSC
Recruitment Contact
Sarah Booker
843-792-9190
bookers@musc.edu

Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry (IPF-PRO)

Date Added
May 13th, 2014
PRO Number
Pro00033910
Researcher
Timothy Whelan

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

The purpose of this research registry is to better understand the natural history of Idiopathic Pulmonary Fibrosis and current practice patterns. The IPF-PRO registry will be used to collect data and biological samples that will support future research studies by identifying disease biomarkers for IPF. Through these studies, researchers hope to find new ways to detect, treat, and maybe prevent or cure health problems. Some of these studies may be about how genes affect health and disease, or how a person's genes affect their response to a treatment. Some of these studies may lead to new products, such as drugs or tests for diseases. We are asking you to let us collect and store some of your blood and health information so they might be used in these kinds of future studies.

If you are newly diagnosed with IPF and are eligible for participation in IPF-PRO, you will be asked to sign a consent form to become enrolled if you agree to be in this registry. At enrollment a member of MUSC research staff will collect information from you and about your medical history and medical care, as well as information about the types of health insurance (public or private) that you have. As part of your participation in this registry, you will be required to sign a medical release form giving permission for your medical records to be reviewed for the purposes of data collection for the registry. This is an observational registry which means you will not receive any investigational treatments or investigational drugs, and only minimally invasive procedures will be performed (blood draws) at scheduled clinic visits. In addition to the face to face visits for self-administered participant reported questionnaires and blood collection, at roughly 6-month intervals, sites will review the participant's medical records. Your disease management and treatment decisions will be determined by you and your health care professional. Subjects will be followed until the last enrolled subject has been followed for 3 years up to a maximum of 5 years.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu



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