Parkinson's DiseaseNCT00291265
Measures of Motor Impairment in Early Parkinson's Disease
An observational study of Parkinson's Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Parkinson's Disease
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2006to 2 Feb 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Hoehn and Yahr stage less than 3.
- No clinical evidence of other parkinsonian syndromes (Progressive supranuclear palsy, Multiple system atrophy, drug-induced parkinsonism, lewy body dementia).
- 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.
- 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.
- 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.
- Patient must demonstrate proficiency in the use of the At Home Testing Program in an office setting.
- 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.
Who cannot join
- Patients who have comorbid neurological or psychiatric disorders (even if they don't require medications).
- Patients who have had Parkinson's disease for more than 5 years.
- Patients who have another movement disorder (Progressive supranuclear palsy, Multiple system atrophy, drug-induced parkinsonism, Lewy body dementia).
- Disruptive non-compliance with requirements of the study causing an inability to collect valid and clean data.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Testing Objective 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.
Read more
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...
Read the 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.
- Conditions
- Parkinson's Disease
- Keywords
- Bradykinesia, Tremor, Speech, Rigidity, Neurodegeneration, Parkinson Disease, PD
- Medical subject headings
- Parkinson Disease, Hypokinesia, Tremor, Speech, Muscle Rigidity, Nerve Degeneration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2006 (estimated)
- Study start9 Feb 2006
- Study completion2 Feb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291265
- Sponsor's protocol ID
- 060096
- Other IDs
- 06-N-0096
- Status last verified
- 2 Feb 2010
- First submitted
- 11 Feb 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Adler CH, Hentz JG, Joyce JN, Beach T, Caviness JN. 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. doi: 10.1016/s1353-8020(02)00012-3.
PubMed 12473400Bloem BR, Beckley DJ, van Hilten BJ, Roos RA. Clinimetrics of postural instability in Parkinson's disease. J Neurol. 1998 Oct;245(10):669-73. doi: 10.1007/s004150050265.
PubMed 9776467Bronte-Stewart HM, Ding L, Alexander C, Zhou Y, Moore GP. Quantitative digitography (QDG): a sensitive measure of digital motor control in idiopathic Parkinson's disease. Mov Disord. 2000 Jan;15(1):36-47. doi: 10.1002/1531-8257(200001)15:13.0.co;2-m.
PubMed 10634240
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Objective Measures of Motor Impairment in Early Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00291265
- Acronym / sponsor ID
- 060096
- Conditions
- Parkinson's Disease
- Keywords
- Bradykinesia, Tremor, Speech, Rigidity, Neurodegeneration, Parkinson Disease, PD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 9 Feb 2006
- Study completion
- 2 Feb 2010
- First posted
- 13 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
Key exclusion criteria (6 listed)
- Patients who have comorbid neurological or psychiatric disorders (even if they don't require medications).
- Patients who have had Parkinson's disease for more than 5 years.
- Patients who have another movement disorder (Progressive supranuclear palsy, Multiple system atrophy, drug-induced parkinsonism, Lewy body dementia).
- Disruptive non-compliance with requirements of the study causing an inability to collect valid and clean data.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 12473400Adler CH, Hentz JG, Joyce JN, Beach T, Caviness JN. 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. doi: 10.1016/s1353-8020(02)00012-3.
- Background: PubMed 9776467Bloem BR, Beckley DJ, van Hilten BJ, Roos RA. Clinimetrics of postural instability in Parkinson's disease. J Neurol. 1998 Oct;245(10):669-73. doi: 10.1007/s004150050265.
- Background: PubMed 10634240Bronte-Stewart HM, Ding L, Alexander C, Zhou Y, Moore GP. Quantitative digitography (QDG): a sensitive measure of digital motor control in idiopathic Parkinson's disease. Mov Disord. 2000 Jan;15(1):36-47. doi: 10.1002/1531-8257(200001)15:13.0.co;2-m.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00291265, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.