Status:
COMPLETED
Measures of Motor Impairment in Early Parkinson's Disease
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-85 years
Brief Summary
This study will test the accuracy of a new home-use electronic device that measures and records small changes in Parkinson's disease symptoms, such as tremor and impaired movement and speech. The test...
Detailed Description
Objective: Because neuroprotective strategies in Parkinson's disease are primarily aimed at intervening in the early phase of disease, appropriate measures of minor, subtle parkinsonian impairments ne...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- PD, defined with at least two of the following cardinal features: rest tremor, bradykinesia, rigidity with PD diagnosis less than or equal to 5 years.
- Hoehn and Yahr stage less than 3.
- No clinical evidence of other parkinsonian syndromes (Progressive supranuclear palsy, Multiple system atrophy, drug-induced parkinsonism, lewy body dementia).
- The patient must not be on any drug therapy for symptomatic control of parkinsonism, specifically levodopa, dopamine agonist, amantadine, anticholinergic drugs, COMT-inhibitors, selegiline while participating in the initial 6 months of the study.
- Patients must express a willingness and intent to remain off all medications that could affect parkinsonism for the first 6 months of the study without first informing the site PI. Starting an anti-Parkinson medication does not necessarily disqualify a patient from continuing with the study. After the initial 6 months of participation, the patients will be allowed to start a anti-Parkinson medications.
- Patient must express a willingness and intent to remain off of all medications that could affect parkinsonism for the first 6 months of the study without first informing the site PI. Starting an anti-Parkinson medication does not necessarily disqualify a patient from continuing with the study. After the initial 6 months of participation, the patients will be allowed to start anti-Parkinson medications.
- Patient must demonstrate proficiency in the use of the At Home Testing Program in an office setting.
- Participants must be willing to have a technician come to their homes to set up the equipment, check on it periodically, and remove it at study end.
- EXCLUSION CRITERIA:
- Patients who have comorbid neurological or psychiatric disorders (even if they don't require medications).
- Patients who have had Parkinson's disease for more than 5 years.
- Patients who have another movement disorder (Progressive supranuclear palsy, Multiple system atrophy, drug-induced parkinsonism, Lewy body dementia).
- Disruptive non-compliance with requirements of the study causing an inability to collect valid and clean data.
- Inability to accurately perform the task required of this study (i.e. cannot use the equipment properly and to transfer data using a simple USB connection).
- Please note that there is no inclusion or exclusion criteria based on depression or dementia. However, if these problems interfered with proficiency of data acquisition during the screening phase, they will not be eligible. The Hamilton Depression Rating Scale will be the measure used. Depression scale scores will be used as potential co-variants to compliance in exploratory analysis. Furthermore, treatment of other medical conditions will be allowed during the treatment period. Treatment of any feature of Parkinson's disease that does not involve the exclusionary medications (see inclusion/exclusion criteria) will be allowed.
Exclusion
Key Trial Info
Start Date :
February 9 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 2 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00291265
Start Date
February 9 2006
End Date
February 2 2010
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892