ID

21539

Description

Measures of Motor Impairment in Early Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00291265

Link

https://clinicaltrials.gov/show/NCT00291265

Keywords

Versions (1)
  1. 4/26/17 4/26/17 -
Uploaded on

April 26, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00291265

English

Eligibility Parkinson's Disease NCT00291265

1 forms  
Criteria
Description

Criteria

1. 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.
Description

Rest tremor, bradykinesia, rigidity

Data type

boolean

Alias
UMLS CUI [1]
C1112182
UMLS CUI [2]
C0233565
UMLS CUI [3]
C0026837
2. hoehn and yahr stage less than 3.
Description

Hoehn and yahr stage

Data type

boolean

Alias
UMLS CUI [1]
C3639483
3. no clinical evidence of other parkinsonian syndromes (progressive supranuclear palsy, multiple system atrophy, drug-induced parkinsonism, lewy body dementia).
Description

Other parkinsonian syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C0242422
UMLS CUI [1,2]
C0205394
4. 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.
Description

Pharmacotherapy for parkinsonism

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0242422
5. 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.
Description

Willing to change pharmacotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0013216
6. 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.
Description

Willing to change pharmacotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0013216
7. patient must demonstrate proficiency in the use of the at home testing program in an office setting.
Description

Proficiency in home testing

Data type

boolean

Alias
UMLS CUI [1,1]
C0870520
UMLS CUI [1,2]
C0973155
8. 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.
Description

Home visit of technician

Data type

boolean

Alias
UMLS CUI [1,1]
C0020043
UMLS CUI [1,2]
C1556020
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who have comorbid neurological or psychiatric disorders (even if they don't require medications).
Description

Neurological disease or psychatric disorder

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
2. patients who have had parkinson's disease for more than 5 years.
Description

Parkinson's disease duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0872146
UMLS CUI [1,2]
C0747270
3. patients who have another movement disorder (progressive supranuclear palsy, multiple system atrophy, drug-induced parkinsonism, lewy body dementia).
Description

Movement disorder

Data type

boolean

Alias
UMLS CUI [1]
C0026650
4. disruptive non-compliance with requirements of the study causing an inability to collect valid and clean data.
Description

Compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
5. 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).
Description

Ability to perform the tasks

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0039333
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.
Description

Depression or dementia

Data type

boolean

Alias
UMLS CUI [1]
C0011581
UMLS CUI [2]
C0497327
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Similar models

Eligibility Parkinson's Disease NCT00291265

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Rest tremor, bradykinesia, rigidity
Item
1. 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.
boolean
C1112182 (UMLS CUI [1])
C0233565 (UMLS CUI [2])
C0026837 (UMLS CUI [3])
Hoehn and yahr stage
Item
2. hoehn and yahr stage less than 3.
boolean
C3639483 (UMLS CUI [1])
Other parkinsonian syndrome
Item
3. no clinical evidence of other parkinsonian syndromes (progressive supranuclear palsy, multiple system atrophy, drug-induced parkinsonism, lewy body dementia).
boolean
C0242422 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Pharmacotherapy for parkinsonism
Item
4. 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.
boolean
C0013216 (UMLS CUI [1,1])
C0242422 (UMLS CUI [1,2])
Willing to change pharmacotherapy
Item
5. 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.
boolean
C0600109 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
Willing to change pharmacotherapy
Item
6. 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.
boolean
C0600109 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
Proficiency in home testing
Item
7. patient must demonstrate proficiency in the use of the at home testing program in an office setting.
boolean
C0870520 (UMLS CUI [1,1])
C0973155 (UMLS CUI [1,2])
Home visit of technician
Item
8. 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.
boolean
C0020043 (UMLS CUI [1,1])
C1556020 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Neurological disease or psychatric disorder
Item
1. patients who have comorbid neurological or psychiatric disorders (even if they don't require medications).
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Parkinson's disease duration
Item
2. patients who have had parkinson's disease for more than 5 years.
boolean
C0872146 (UMLS CUI [1,1])
C0747270 (UMLS CUI [1,2])
Movement disorder
Item
3. patients who have another movement disorder (progressive supranuclear palsy, multiple system atrophy, drug-induced parkinsonism, lewy body dementia).
boolean
C0026650 (UMLS CUI [1])
Compliance
Item
4. disruptive non-compliance with requirements of the study causing an inability to collect valid and clean data.
boolean
C1321605 (UMLS CUI [1])
Ability to perform the tasks
Item
5. 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).
boolean
C0085732 (UMLS CUI [1,1])
C0039333 (UMLS CUI [1,2])
Depression or dementia
Item
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.
boolean
C0011581 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
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