Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291265
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-02-11
Brief Title:
Measures of Motor Impairment in Early Parkinsons Disease
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Testing Objective Measures of Motor Impairment in Early Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2010-02-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will test the accuracy of a new home-use electronic device that measures and records small changes in Parkinsons 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 patients doctor Detecting Parkinsons disease in its early stages may permit doctors to provide early treatment and slow the rate of disease progression
Patients with early Parkinsons 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 Parkinsons 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 timemovement 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
Patients with early Parkinsons 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 Parkinsons 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 timemovement 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 Parkinsons 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 Parkinsons disease is the Unified Parkinsons 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 Parkinsons 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 timemovement 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 Parkinsons disease it will be particularly applicable to neuroprotective trials currently being designed
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 Parkinsons 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 timemovement 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 Parkinsons disease it will be particularly applicable to neuroprotective trials currently being designed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-N-0096 | None | None | None |