Measures of Motor Impairment in Early Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT00291265|
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : July 2, 2017
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:
Participants' undergo symptoms ratings using the Unified Parkinson's Disease Rating Scale and assessments of memory, thinking and depression.
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...
|Condition or 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.
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Testing Objective Measures of Motor Impairment in Early Parkinson's Disease|
|Study Start Date :||February 9, 2006|
|Study Completion Date :||February 2, 2010|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291265
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|