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Studying Automatic Movements in Patients With Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Parkinson Disease focused on measuring fMRI, Brain Activity, Overlearned, Dual-Task, Mechanism, Parkinson Disease, PD

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA: 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 Patients will be studied only after their medication has been withdrawn for at least 12 hours.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. EXCLUSION CRITERIA: 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.

Sites / Locations

  • National Institute of Neurological Disorders and Stroke (NINDS)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 2, 2003
Last Updated
March 3, 2008
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00063661
Brief Title
Studying Automatic Movements in Patients With Parkinson's Disease
Official Title
A Neuroimaging Study of Automatic Movements in Patients With Parkinson's Disease
Study Type
Observational

2. Study Status

Record Verification Date
May 2005
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
fMRI, Brain Activity, Overlearned, Dual-Task, Mechanism, Parkinson Disease, PD

7. Study Design

Enrollment
30 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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.
Facility Information:
Facility Name
National Institute of Neurological Disorders and Stroke (NINDS)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10094257
Citation
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.
Results Reference
background
PubMed Identifier
9918346
Citation
Cunnington 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.
Results Reference
background
PubMed Identifier
9549504
Citation
Catalan 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.
Results Reference
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Studying Automatic Movements in Patients With Parkinson's Disease

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