Measures of Motor Impairment in Early Parkinson's Disease

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 need to be defined. The gold standard of rating scales for Parkinson's disease is the Unified Parkinson's Disease Rating scale (UPDRS), but it covers the gamut of disability levels and does not specifically focus on early impairments. We have developed a series of motor tasks that can be performed with a home-based computer module so that data can be collected frequently and prospectively without obligating the patient to come to a medical center.

Study population: The study population will consist of patients with mild and early Parkinson disease.

Design: This feasibility study will longitudinally follow 50 patients with mild and early Parkinson's disease who are not receiving symptomatic therapy for the treatment of motor impairment. They will be trained to perform the task and transmit data on a weekly basis.

Outcome measures: We will analyze time-related changes in several domains of motor function (tremor, limb bradykinesia, fine motor bradykinesia, voice, reaction time/movement time) and correlate these changes with the UPDRS at 3 and 6 months. We hypothesize that patients will find this assessment technology easy to use, a positive force in their lives, and that they will be committed to the program throughout its duration. Further, we hypothesize that motor changes will be detected with this technology at a time when UPDRS scores do not show decrements. Over six months, however, declines in the UPDRS will occur and correlate with the decrements in computer-based motor task. If, as we hypothesize, the home-based motor testing program is both feasible and useful in the assessment of early impairments in Parkinson's disease, it will be particularly applicable to neuroprotective trials currently being designed.

• 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.