A Study of Neurophysiologic Changes in Individuals With Parkinson's Disease
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| First Received Date ICMJE | June 30, 2005 | ||||||||
| Last Updated Date | February 8, 2012 | ||||||||
| Start Date ICMJE | May 2003 | ||||||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00117195 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Study of Neurophysiologic Changes in Individuals With Parkinson's Disease | ||||||||
| Official Title ICMJE | Open-Label Validation Study of Neurophysiologic Changes in Individuals With Parkinson's Disease, at Risk for Parkinson's Disease and Healthy Controls | ||||||||
| Brief Summary | The goal of this study is to investigate neurophysiologic tests that have the potential of serving as screening tools for Parkinson's disease. These neurophysiologic tests will be administered to individuals with Parkinson's disease and parkinsonian syndrome and validated against a healthy control population. Specifically, this study will look at changes in motor function, cognitive function, handwriting, speech, and olfactory function in individuals with Parkinson's disease, individuals at risk for Parkinson's disease and healthy controls. |
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| Detailed Description | One of the greatest challenges in Parkinson's research is the identification of individuals who are at risk or have early Parkinson's disease (PD) or parkinsonian syndrome (PS). Subtle signs that do not meet the diagnostic criteria for PD may occur during this period. This study will evaluate a profile of neurophysiologic tests for potentially predictive signs of PD or PS in individuals with PD or PS, those who may be at risk for PD or PS and in a population of individuals without parkinsonian symptoms or any other neurologic conditions. In addition, the study will evaluate serum samples for changes in proteins or metabolites that may be indicators of early changes associated with Parkinson's disease or parkinsonian syndrome. Each study participant will be scheduled for a 90 minute study visit. This visit may include the following procedures:
The study will be conducted at the Institute for Neurodegenerative Disorders (IND), which is a not for profit research institute specializing in Parkinson's disease research. Clinical data will be collected, stored and analyzed at IND to evaluate whether there are significant differences between the performance of the parkinsonian study participants, individuals with risk factors for PD or PS, and the healthy subjects. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: In addition, the study will evaluate serum samples for changes in proteins or metabolites that may be indicators of early changes associated with Parkinson's disease or parkinsonian syndrome. |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | These neurophysiologic tests will be administered to individuals with Parkinson's disease and parkinsonian syndrome and validated against a healthy control population. |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Automated Neuropsychological Assessment Matrix
This study will evaluate a profile of neurophysiologic tests for potentially predictive signs of PD or PS in individuals with PD or PS, those who may be at risk for PD or PS and in a population of individuals without parkinsonian symptoms or any other neurologic conditions. In addition, the study will evaluate serum samples for changes in proteins or metabolites that may be indicators of early changes associated with Parkinson's disease or parkinsonian syndrome. |
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| Study Group/Cohort (s) | PD/PS
Intervention: Device: Automated Neuropsychological Assessment Matrix |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 620 | ||||||||
| Completion Date | January 2012 | ||||||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: As a participant with PD or PS:
For Healthy Control:
Exclusion Criteria: As a participant with PD or PS:
For Healthy Control:
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| Gender | Both | ||||||||
| Ages | 22 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00117195 | ||||||||
| Other Study ID Numbers ICMJE | Neurophysiologic, Neurophys | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Kenneth Marek, MD, Institute for Neurodegenerative Disorders | ||||||||
| Study Sponsor ICMJE | Institute for Neurodegenerative Disorders | ||||||||
| Collaborators ICMJE | Molecular NeuroImaging | ||||||||
| Investigators ICMJE |
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| Information Provided By | Institute for Neurodegenerative Disorders | ||||||||
| Verification Date | February 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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