NIH Clinical Research Studies

Protocol Number: 06-N-0096

Active Followup, Protocols NOT Recruiting New Patients

Title:
Testing Objective Measures of Motor Impairment in Early Parkinson's Disease
Number:
06-N-0096
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 during the study, participants are asked to transfer the information from the Actiwatch to the electronic monitoring device.

3-month Visit

Participants come to the NIH clinic with the electronic device and the Actiwatch to test that the devices are working properly and to undergo standard tests to evaluate their Parkinson's symptoms.

6-month Visit

Participants repeat the procedures for the 3-month visit, plus undergo tests of memory and thinking.

Sponsoring Institute:
National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail
Type: No longer recruiting/follow-up only
Gender: Male & Female
Referral Letter Required: Yes
Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
Special Instructions:
Currently Not Provided
Keyword(s):
Bradykinesia
Tremor
Speech
Rigidity
Neurodegeneration
Recruitment Keyword(s):
Parkinson Disease
PD
Condition(s):
Parkinson's Disease
Investigational Drug(s):
None
Investigational Device(s):
None
Interventions:
None
Supporting Site:
National Institute of Neurological Disorders and Stroke

Contact(s):
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):
Motor impairment in normal aging, clinically possible Parkinson's disease, and clinically probable Parkinson's disease: longitudinal evaluation of a cohort of prospective brain donors. Parkinsonism Relat Disord. 2002 Dec;9(2):103-10.

Clinimetrics of postural instability in Parkinson's disease.J Neurol. 1998 Oct;245(10):669-73. PMID: 9776467

Quantitative digitography (QDG): a sensitive measure of digital motor control in idiopathic Parkinson's disease.Mov Disord. 2000 Jan;15(1):36-47. MID: 10634240

Active Followup, Protocols NOT Recruiting New Patients

If you have:


Command Menu Bar

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home


Clinical Center LogoNational Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/30/2009

Search The Studies Help Questions