ID

24432

Description

Effect of Stimulus Rate on Cognitive and Motor Activity in Young Subjects, Elderly Subjects, and Patients With Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00026598

Link

https://clinicaltrials.gov/show/NCT00026598

Keywords

Versions (1)
  1. 7/31/17 7/31/17 -
Uploaded on

July 31, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00026598

English

Eligibility Parkinson's Disease NCT00026598

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
imaging methods (e.g., structural mri) may be included as a part of the pre-study evaluation. pd patients should be at a relatively early stage of the disease and must be devoid of any other neuropsychiatric symptoms, especially dementia. to assure this, they are to be rated by updrs (motor sub-scale) and standard neuropsychological batteries (e.g., mini-mental test).
Description

neuropsychiatric symptoms

Data type

boolean

Alias
UMLS CUI [1]
C4285807
thirty pd patients with age 40 and higher will be recruited. patients may be male or female. patients will be asked to withhold any medication that can influence central nervous system (e.g. levodopa) at least 8 hours prior to the examination. they will also asked to abstain from alcohol for 24 hours before the study.
Description

age, medication, alcohol

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0013227
UMLS CUI [3]
C0680142
sixty normal volunteers ranging from 21-75 will be included. normal volunteers will be recruited from people who are registered as hmcs normal volunteers. patients would be referred from the hmcs clinic. all subjects participating in mr studies should have a valid clinical center medical record number. procedures for the fmri experiment will follow the standard operating procedures of the hmcs neuroimaging group.
Description

normal volunteers

Data type

boolean

Alias
UMLS CUI [1]
C1708335
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pd patients younger than 40 years will be excluded from the study since they are considered to be young-onset pd and have slightly different characteristics from typical idiopathic pd. normal subjects younger than 21 years old will also be excluded.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients with mri findings consistent with organic brain lesions such as brain tumors, stroke, trauma or avm's will be excluded.
Description

brain lesions

Data type

boolean

Alias
UMLS CUI [1]
C0221505
patients with progressive neurological disorders other than pd will be excluded.
Description

progressive neurological disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C1335499
patients with a history of significant medical disorders such as cancers, or requiring continuous treatment with drugs other than antiparkinsonian medication, will be excluded.
Description

significant medical disorders

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C2015819
subjects who have any contraindications to mri will be excluded from the fmri part of the study. we will not scan pregnant women because safety of high magnetic field to fetus is not established. therefore, we will administer a urine pregnancy test for any female subjects of childbearing potential prior to functional mri scan.
Description

mri contraindication

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0522473
patients not capable of giving informed consent will be excluded.
Description

not capable of giving informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
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Similar models

Eligibility Parkinson's Disease NCT00026598

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
neuropsychiatric symptoms
Item
imaging methods (e.g., structural mri) may be included as a part of the pre-study evaluation. pd patients should be at a relatively early stage of the disease and must be devoid of any other neuropsychiatric symptoms, especially dementia. to assure this, they are to be rated by updrs (motor sub-scale) and standard neuropsychological batteries (e.g., mini-mental test).
boolean
C4285807 (UMLS CUI [1])
age, medication, alcohol
Item
thirty pd patients with age 40 and higher will be recruited. patients may be male or female. patients will be asked to withhold any medication that can influence central nervous system (e.g. levodopa) at least 8 hours prior to the examination. they will also asked to abstain from alcohol for 24 hours before the study.
boolean
C0001779 (UMLS CUI [1])
C0013227 (UMLS CUI [2])
C0680142 (UMLS CUI [3])
normal volunteers
Item
sixty normal volunteers ranging from 21-75 will be included. normal volunteers will be recruited from people who are registered as hmcs normal volunteers. patients would be referred from the hmcs clinic. all subjects participating in mr studies should have a valid clinical center medical record number. procedures for the fmri experiment will follow the standard operating procedures of the hmcs neuroimaging group.
boolean
C1708335 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
age
Item
pd patients younger than 40 years will be excluded from the study since they are considered to be young-onset pd and have slightly different characteristics from typical idiopathic pd. normal subjects younger than 21 years old will also be excluded.
boolean
C0001779 (UMLS CUI [1])
brain lesions
Item
patients with mri findings consistent with organic brain lesions such as brain tumors, stroke, trauma or avm's will be excluded.
boolean
C0221505 (UMLS CUI [1])
progressive neurological disorders
Item
patients with progressive neurological disorders other than pd will be excluded.
boolean
C0027765 (UMLS CUI [1,1])
C1335499 (UMLS CUI [1,2])
significant medical disorders
Item
patients with a history of significant medical disorders such as cancers, or requiring continuous treatment with drugs other than antiparkinsonian medication, will be excluded.
boolean
C0009488 (UMLS CUI [1])
C2015819 (UMLS CUI [2])
mri contraindication
Item
subjects who have any contraindications to mri will be excluded from the fmri part of the study. we will not scan pregnant women because safety of high magnetic field to fetus is not established. therefore, we will administer a urine pregnancy test for any female subjects of childbearing potential prior to functional mri scan.
boolean
C0024485 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
not capable of giving informed consent
Item
patients not capable of giving informed consent will be excluded.
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
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