A Study of Neurophysiologic Changes in Individuals With Parkinson's Disease
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Parkinson's Disease Parkinsonian Syndrome |
Device: Automated Neuropsychological Assessment Matrix |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Open-Label Validation Study of Neurophysiologic Changes in Individuals With Parkinson's Disease, at Risk for Parkinson's Disease and Healthy Controls |
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.
| Enrollment: | 620 |
| Study Start Date: | May 2003 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| PD/PS |
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. |
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:
- Screening for eligibility
- Clinical assessments
- Neurological evaluation
- Computerized cognitive testing
- Olfactory testing
- Computerized handwriting testing
- Speech evaluation
- Blood sample for biochemical and/or genetic analysis
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.
Eligibility| Ages Eligible for Study: | 22 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
These neurophysiologic tests will be administered to individuals with Parkinson's disease and parkinsonian syndrome and validated against a healthy control population.
Inclusion Criteria:
As a participant with PD or PS:
- Age >21
- Clinical diagnosis of PD or PS (at least two of the three cardinal symptoms: resting tremor, rigidity, bradykinesia) and a clinical response to dopaminergic therapy
For Healthy Control:
- Age >21
Exclusion Criteria:
As a participant with PD or PS:
- Any other concomitant neurologic condition likely to interfere with handwriting, use of the computer, or other motor tasks tested in this study (e.g. stroke, demyelinating disease, visual loss)
For Healthy Control:
- Any indication of parkinsonism on examination
- Any other concomitant neurologic condition likely to interfere with handwriting, use of the computer, or other motor tasks (e.g. stroke, demyelinating disease, visual loss)
Contacts and Locations| United States, Connecticut | |
| Institute for Neurodegenerative Disorders | |
| New Haven, Connecticut, United States, 06510 | |
| Principal Investigator: | Kenneth L Marek, MD | Institute for Neurodegenerative Disorders |
| Study Director: | Laura Leary | Institute for Neurodegenerative Disorders |
More Information
Publications:
| Responsible Party: | Kenneth Marek, MD, Principal Investigator, Institute for Neurodegenerative Disorders |
| ClinicalTrials.gov Identifier: | NCT00117195 History of Changes |
| Other Study ID Numbers: | Neurophysiologic, Neurophys |
| Study First Received: | June 30, 2005 |
| Last Updated: | February 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Institute for Neurodegenerative Disorders:
|
parkinson diagnosis screening |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on June 18, 2013