Measures of Motor Impairment in Early Parkinson's Disease
Measures of Motor Impairment in Early Parkinson's Disease
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 testing is done at home and the results are sent by Internet to the patient's
 doctor. Detecting Parkinson's disease in its early stages may permit doctors to provide early
 treatment and slow the rate of disease progression.

 Patients with early Parkinson's disease (less than 5 years) with rest tremors and
 bradykinesia (slowness and difficulty of movement) who are not taking medications for the
 disease may be eligible for this study. Candidates are screened with training and practice in
 using the home monitoring device over 2-3 weeks. Those who demonstrate proficiency with the
 device may be enrolled in the study.

 Participants undergo the following tests and procedures:

 Baseline Visit

 Participants' undergo symptoms ratings using the Unified Parkinson's Disease Rating Scale and
 assessments of memory, thinking and depression.

 At-home testing

 Participants begin at-home testing with the monitoring device after the baseline visit and
 repeat the tests weekly for 6 months. The test information is automatically uploaded to a
 home computer (provided by the study) and sent to the investigators via Internet. The test
 procedure is as follows:

 -  Introduction questionnaire (1 minute): Participants are questioned about how they are
 feeling at test time.

 -  Pegboard test (4 minutes): At the sound of a tone, the participant moves eight pegs from
 the right to the left using their right and then left hand.

 -  Tapping test (3 minutes): At the sound of a tone, the participant alternately presses
 two buttons with the right index finger and then the left index finger.

 -  Reaction time/movement time testing (3 minutes): At the sound of a tone, the participant
 moves his or her index finger from one button to the other, first with the right hand
 and then with the left hand.

 -  Digitography testing (4 minutes): At the sound of a tone, the participant alternates
 between pressing two keys with the index and middle fingers.

 -  Speech + Actiwatch tremor data upload (7 minutes): The participant: 1) takes a deep
 breath and says "ahhh" for as long as possible; 2) is shown a picture and, at the sound
 of a tone, is asked to tell a story about the picture; 3) uploads the tremor data from
 the Actiwatch (a device worn on the wrist that records tremors).

 -  At specified times du...
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:

 1. 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.

 2. Hoehn and Yahr stage less than 3.

 3. No clinical evidence of other parkinsonian syndromes (Progressive supranuclear
 palsy, Multiple system atrophy, drug-induced parkinsonism, lewy body dementia).

 4. 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.

 5. 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.

 6. 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.

 7. Patient must demonstrate proficiency in the use of the At Home Testing Program in
 an office setting.

 8. 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:

 1. Patients who have comorbid neurological or psychiatric disorders (even if they don't
 require medications).

 2. Patients who have had Parkinson's disease for more than 5 years.

 3. Patients who have another movement disorder (Progressive supranuclear palsy, Multiple
 system atrophy, drug-induced parkinsonism, Lewy body dementia).

 4. Disruptive non-compliance with requirements of the study causing an inability to
 collect valid and clean data.

 5. 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.