Parkinson DiseaseNCT00063661
Studying Automatic Movements in Patients With Parkinson's Disease
An observational study of Parkinson Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Parkinson's disease patients usually have difficulty making automatic movements. Automatic movements are movements people often make without conscious thought. The purpose of this study is to investigate regions of the brain that affect automatic movements and to understand the movements of Parkinson's patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to May 2005
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Thirty patients with PD will be included in the study.
- The diagnosis of PD is based on medical history, physical and neurological examinations, response to levodopa or dopaminergic drugs, and laboratory tests and MRI scans to exclude other diseases.
- Patients will be assessed with the Unified Parkinson's Disease Rating Scale (UPDRS) and Mini-Mental State Exam (MMSE). Only patients with mild to moderate motor disability (UDRS less than or equal to 40) and without cognitive impairment (MMT score greater than or equal to 25) will be investigated.
- Patients will be studied only after their medication has been withdrawn for at least 12 hours.
- All subjects participating in the study should have a valid Clinical Center Medical Record Number.
- The fMRI experiment will follow the standard operating procedures of the HMCS Neuroimaging Group.
Who cannot join
- Subjects with psychiatric disorders or severe motor disabilities will be excluded.
- Subjects with pacemakers, cardiac or neural defibrillators, intracranial aneurysm clips, intraorbital metallic structures, insulin pumps, cochlear implants, and other metallic objects will not be scanned.
- Women who are pregnant are excluded from MRI because the safety of the fetus in the presence of high magnetic fields is not established. Therefore, all women of childbearing potential will have a pregnancy test performed, which must be negative, before proceeding.
- Subjects under age 18 will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: A Neuroimaging Study of Automatic Movements in Patients With Parkinson's Disease
Parkinson's disease patients usually have difficulty making automatic movements. Automatic movements are movements people often make without conscious thought.
The purpose of this study is to investigate regions of the brain that affect automatic movements and to understand the movements of Parkinson's patients. Investigators hope this knowledge will lead to better treatment for the disease.
Thirty participants will be enrolled in this study. Each will give a medical history and undergo a brief physical exam. Participants will have two MRI scans, each lasting approximately 1.5 hours. During these scans, they may be asked to move their right or left hands or to remember some letters that they have been shown. Before undergoing the second scan, participants will be asked to practice the tasks until they can perform them correctly.
Read the detailed description
Patients with Parkinson's Disease (PD) are deficient in making automatic movements. The underlying neural correlates of the problem are not understood. In the present study, to investigate the brain activity contributing to this disorder, we will use specially designed dual-task paradigm and the functional magnetic resonance imaging (fMRI) technique. Thirty patients with PD will be asked to perform sequential finger-tapping movement with the right hand; results will be analyzed from 20 patients who achieve automaticity as defined in the study. In addition, we will use a dual-task paradigm to evaluate automaticity by having subjects perform either a distraction task (involving visual memory) or an interference task (tapping with the left hand) simultaneously with the sequential movements. Patients will practice to achieve automaticity. fMRI will be obtained before and after achieving automaticity. By analyzing fMRI results, we will explore the brain regions associated with deficiency of automatic movements in PD patients.
- Conditions
- Parkinson Disease
- Keywords
- fMRI, Brain Activity, Overlearned, Dual-Task, Mechanism, Parkinson Disease, PD
- Medical subject headings
- Parkinson Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2003 (estimated)
- Study startJun 2003
- Study completionMay 2005
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 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
- 30 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063661
- Sponsor's protocol ID
- 030236
- Other IDs
- 03-N-0236
- Status last verified
- May 2005
- First submitted
- 2 Jul 2003
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Catalan MJ, Ishii K, Honda M, Samii A, Hallett M. A PET study of sequential finger movements of varying length in patients with Parkinson's disease. Brain. 1999 Mar;122 ( Pt 3):483-95. doi: 10.1093/brain/122.3.483.
PubMed 10094257Cunnington R, Iansek R, Bradshaw JL. Movement-related potentials in Parkinson's disease: external cues and attentional strategies. Mov Disord. 1999 Jan;14(1):63-8. doi: 10.1002/1531-8257(199901)14:13.0.co;2-v.
PubMed 9918346Catalan MJ, Honda M, Weeks RA, Cohen LG, Hallett M. The functional neuroanatomy of simple and complex sequential finger movements: a PET study. Brain. 1998 Feb;121 ( Pt 2):253-64. doi: 10.1093/brain/121.2.253.
PubMed 9549504
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Neuroimaging Study of Automatic Movements in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00063661
- Acronym / sponsor ID
- 030236
- Conditions
- Parkinson Disease
- Keywords
- fMRI, Brain Activity, Overlearned, Dual-Task, Mechanism, Parkinson Disease, PD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jun 2003
- Study completion
- May 2005
- First posted
- 2 Jul 2003 (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.
Parkinson's disease patients usually have difficulty making automatic movements. Automatic movements are movements people often make without conscious thought.
The purpose of this study is to investigate regions of the brain that affect automatic movements and to understand the movements of Parkinson's patients. Investigators hope this knowledge will lead to better treatment for the disease.
Thirty participants will be enrolled in this study. Each will give a medical history and undergo a brief physical exam. Participants will have two MRI scans, each lasting approximately 1.5 hours. During these scans, they may be asked to move their right or left hands or to remember some letters that they have been shown. Before undergoing the second scan, participants will be asked to practice the tasks until they can perform them correctly.
Detailed description
Patients with Parkinson's Disease (PD) are deficient in making automatic movements. The underlying neural correlates of the problem are not understood. In the present study, to investigate the brain activity contributing to this disorder, we will use specially designed dual-task paradigm and the functional magnetic resonance imaging (fMRI) technique. Thirty patients with PD will be asked to perform sequential finger-tapping movement with the right hand; results will be analyzed from 20 patients who achieve automaticity as defined in the study. In addition, we will use a dual-task paradigm to evaluate automaticity by having subjects perform either a distraction task (involving visual memory) or an interference task (tapping with the left hand) simultaneously with the sequential movements. Patients will practice to achieve automaticity. fMRI will be obtained before and after achieving automaticity. By analyzing fMRI results, we will explore the brain regions associated with deficiency of automatic movements in PD patients.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Thirty patients with PD will be included in the study.
- The diagnosis of PD is based on medical history, physical and neurological examinations, response to levodopa or dopaminergic drugs, and laboratory tests and MRI scans to exclude other diseases.
- Patients will be assessed with the Unified Parkinson's Disease Rating Scale (UPDRS) and Mini-Mental State Exam (MMSE). Only patients with mild to moderate motor disability (UDRS less than or equal to 40) and without cognitive impairment (MMT score greater than or equal to 25) will be investigated.
- Patients will be studied only after their medication has been withdrawn for at least 12 hours.
- All subjects participating in the study should have a valid Clinical Center Medical Record Number.
Key exclusion criteria (4 listed)
- Subjects with psychiatric disorders or severe motor disabilities will be excluded.
- Subjects with pacemakers, cardiac or neural defibrillators, intracranial aneurysm clips, intraorbital metallic structures, insulin pumps, cochlear implants, and other metallic objects will not be scanned.
- Women who are pregnant are excluded from MRI because the safety of the fetus in the presence of high magnetic fields is not established. Therefore, all women of childbearing potential will have a pregnancy test performed, which must be negative, before proceeding.
- Subjects under age 18 will be excluded.
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 4 Mar 2008.
- Background: PubMed 10094257Catalan MJ, Ishii K, Honda M, Samii A, Hallett M. A PET study of sequential finger movements of varying length in patients with Parkinson's disease. Brain. 1999 Mar;122 ( Pt 3):483-95. doi: 10.1093/brain/122.3.483.
- Background: PubMed 9918346Cunnington R, Iansek R, Bradshaw JL. Movement-related potentials in Parkinson's disease: external cues and attentional strategies. Mov Disord. 1999 Jan;14(1):63-8. doi: 10.1002/1531-8257(199901)14:13.0.co;2-v.
- Background: PubMed 9549504Catalan MJ, Honda M, Weeks RA, Cohen LG, Hallett M. The functional neuroanatomy of simple and complex sequential finger movements: a PET study. Brain. 1998 Feb;121 ( Pt 2):253-64. doi: 10.1093/brain/121.2.253.
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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 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 6 inclusion and 4 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 4 Mar 2008. 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 NCT00063661, 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 4 Mar 2008.