Measures of Motor Impairment in Early Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

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 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...
    

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 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.
    

Keywords: Bradykinesia; Tremor; Speech; Rigidity; Neurodegeneration; Parkinson Disease; PD