Clinical Trials

3 studies in Parkinson's Disease

1. Neurotransmitter Measurements Using Wireless Instantaneous Neurotransmitter Concentration System (WINCS) During Deep Brain Stimulation Neurosurgery Rochester, MN View Summary
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   Neurotransmitter Measurements Using Wireless Instantaneous Neurotransmitter Concentration System (WINCS) During Deep Brain Stimulation Neurosurgery

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   In this study, the investigators will monitor extracellular neurotransmitter levels using a probe that is able to perform real time electrochemical detection during deep brain stimulation surgery. The overall question this study is designed to answer is: Are there neurotransmitters released during deep brain stimulation?

   NCT ID:

   NCT01705301

   IRB Number:

   09-007441

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   Who can I contact for additional information about this study?

   Rochester: Debra Gorman, RN 507-266-3044
                       
   
   
   

2. Weight Loss in Parkinson's Disease and Role of Small Bowel Bacterial Overgrowth Scottsdale and Phoenix, AZ View Summary
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   Weight Loss in Parkinson's Disease and Role of Small Bowel Bacterial Overgrowth

   Location:

   Scottsdale and Phoenix, AZ

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Hypothesis: Small bowel bacterial overgrowth is an important contributor to the development of weight loss in individuals with Parkinson's disease. Specific aims: 1) To determine the prevalence of SBBO in consecutive patients seen in a Parkinson's disease specialty clinic, and 2) To evaluate the effect of SBBO treatment in PD patients with weight loss. Study design: Prospective, observational case-control study with open-label therapeutic component. Cases will be defined as those PD patients who've experienced significant weight loss while Controls will be defined as those PD patients who have not experienced significant weight loss. Part 1: Consecutive patients seen in the Parkinson's disease clinic at MCA will be approached to participate. After the determination of their eligibility and appropriate signed informed consent, all PD patients (i.e., both Case and Control groups) will undergo the following: 1. Assessment of demographic features, weight history and PD history 2. PD and other medications 3. Determination of PD severity using the Unified Parkinson's Disease rating scale 4. Evaluation of gastrointestinal symptoms (GISSI and modified GISSI) 5. Determination of usual calorie and nutrient intake (Brief Block Food Frequency Questionnaire) 6. Paffenbarger physical activity questionnaire 7. Quality of life (SF12 and PD-specific) 8. HAD survey 9. Glucose hydrogen breath test (SBBO test) 10. Qualitative assessments of smell and taste All questionnaires will be completed during the 2 hour breath test. Part 2: All individuals in the weight loss group (i.e., only the Case group) will be offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment will not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects will receive antibiotic treatment. The patient will be contacted by phone 1 month after treatment at which time the presence of GI symptoms will be determined and inquiry made about any adverse effects related to rifaximin use. GI symptoms, quality of life, weight measurement and breath testing will be repeated at a 3 month study visit.

   NCT ID:

   NCT01662791

   IRB Number:

   11-006817

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   Who can I contact for additional information about this study?

   
   Scottsdale: Michaele Menghini 480-301-4319
                       
   
   

3. Functional Magnetic Resonance Imaging (fMRI) During Deep Brain Stimulation (DBS) to Treat Parkinson's Disease Rochester, MN View Summary
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   Functional Magnetic Resonance Imaging (fMRI) During Deep Brain Stimulation (DBS) to Treat Parkinson's Disease

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Deep brain stimulation (DBS) of the subthalamic nucleus (STN) within the thalamocortical basal ganglion (BG) complex is an effective neurosurgical approach for treating motor symptoms of Parkinson's disease (PD). However, because the nature of its underlying mechanisms and clinical effects are not fully understood, precision targeting, decreasing adverse effects, and improving clinical outcomes represent major clinical and scientific challenges in PD and other disorders treated by DBS. Our goal is to investigate the inter-relationships between site-specific neural activation and clinical outcomes during STN DBS. To do so, we will perform non-invasive functional Magnetic Resonance Imaging (fMRI) to investigate DBS-mediated activation of thalamocortical BG network circuitry. Our proposed protocol involves the addition of intraoperative fMRI to the standard DBS protocol in order to determine the major sites of activation in the thalamocortical BG complex during application of clinically effective DBS to the dorsal and ventral regions of the STN (dSTN and ventral subthalamic nucleus (vSTN), respectively). Patients will undergo clinical assessment using the Unified Parkinson's Disease Rating Scale (UPDRS) to determine the relative efficacy of dSTN and vSTN DBS, applied during the fMRI and at every standard follow visit post-surgery. Our Specific Aims are to: (1) Identify fMRI-activated brain regions by vSTN and dSTN DBS in PD patients and (2) correlate fMRI activation with clinical outcomes (UPDRS) and side effects. With the goal of improving DBS electrode targeting for optimal and reproducible clinical outcomes, these experiments will be the first attempt to relate site-specific DBS with functional in vivo imaging data and quantitative longitudinal clinical outcome measures in PD patients.

   NCT ID:

   NCT01809613

   IRB Number:

   12-009020

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   Who can I contact for additional information about this study?

   Rochester: Emily Knight 507-293-0512