ID

36806

Description

Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02458430

Link

https://clinicaltrials.gov/show/NCT02458430

Keywords

Versions (1)
  1. 6/11/19 6/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 11, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT02458430

English

Eligibility Parkinson's Disease NCT02458430

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 50 and above (m/f).
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. pd diagnosis (with or without mild cognitive impairment; mci) will follow the uk parkinson's disease society brain bank research center (ukpdsbrc) clinical diagnostic criteria for pd (47), consistent with the typical nigrostriatal denervation pattern on vmat2. absence of significant dementia confirmed by neuropsychological testing. modified hoehn and yahr stages 1-4 (48, 49).
Description

Parkinson Disease | Mild cognitive disorder | Mild cognitive disorder Absent | Denervation Pattern Nigrostriate tract VMAT2 | Dementia Absent Neuropsychological Tests | UPDRS - Modified Hoehn and Yahr Staging

Data type

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2]
C1270972
UMLS CUI [3,1]
C1270972
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0011307
UMLS CUI [4,2]
C0449774
UMLS CUI [4,3]
C4323184
UMLS CUI [4,4]
C0246932
UMLS CUI [5,1]
C0497327
UMLS CUI [5,2]
C0332197
UMLS CUI [5,3]
C0027902
UMLS CUI [6]
C3639878
3. psp diagnosis will follow the ninds-psp clinical diagnostic criteria (50, 51).
Description

Progressive supranuclear palsy

Data type

boolean

Alias
UMLS CUI [1]
C0038868
4. all pd subjects will be required to have nigrostriatal dopaminergic denervation as demonstrated by [11c]dtbz pet imaging (52, 53). subjects with parkinsonism and absence of this pd-typical pattern will be re-categorized .
Description

Denervation Dopaminergic Neurons Nigrostriate tract | (18F)FP-DTBZ

Data type

boolean

Alias
UMLS CUI [1,1]
C0011307
UMLS CUI [1,2]
C1512035
UMLS CUI [1,3]
C4323184
UMLS CUI [2]
C3661295
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. presence of significant dementia. 2. disorders which may resemble pd or psp, such as dementia with lewy bodies, vascular dementia, normal pressure hydrocephalus, multiple system atrophy, corticobasal ganglionic degeneration, or toxic causes of parkinsonism. the use of the ukpdsbrc and ninds-psp clinical diagnostic criteria will mitigate the inclusion of patients with atypical parkinsonism.
Description

Dementia | Disease Similar Parkinson Disease | Disease Similar Progressive supranuclear palsy | Lewy Body Disease | Dementia, Vascular | Hydrocephalus, Normal Pressure | Multiple System Atrophy | Corticobasal degeneration | Cause Toxic Parkinsonian Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2348205
UMLS CUI [2,3]
C0030567
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C2348205
UMLS CUI [3,3]
C0038868
UMLS CUI [4]
C0752347
UMLS CUI [5]
C0011269
UMLS CUI [6]
C0020258
UMLS CUI [7]
C0393571
UMLS CUI [8]
C0393570
UMLS CUI [9,1]
C0015127
UMLS CUI [9,2]
C1407029
UMLS CUI [9,3]
C0242422
3. subjects on neuroleptic (except for low dose quetiapine 25-50 mg/d), anticholinergic (trihexyphenidyl, benztropine), cholinesterase inhibitors. subjects with prior exposure to disallowed medications may be eligible if there has been an interval of > 2 months off these medications.
Description

Antipsychotic Agents | Exception Quetiapine Low dose | Anticholinergic Agents | Trihexyphenidyl | Benztropine | Cholinesterase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0123091
UMLS CUI [2,3]
C0445550
UMLS CUI [3]
C0242896
UMLS CUI [4]
C0041009
UMLS CUI [5]
C0005098
UMLS CUI [6]
C0008425
4. evidence of a large vessel stroke in a clinically relevant area (cerebral cortex, basal ganglia, thalamus) or mass lesion on structural brain imaging (mri or ct).
Description

Large vessel Cerebrovascular accident Cerebral cortex | Large vessel Cerebrovascular accident Basal Ganglia | Large vessel Cerebrovascular accident Thalamus | Mass lesion MRI | Mass lesion CT

Data type

boolean

Alias
UMLS CUI [1,1]
C0225990
UMLS CUI [1,2]
C0038454
UMLS CUI [1,3]
C0007776
UMLS CUI [2,1]
C0225990
UMLS CUI [2,2]
C0038454
UMLS CUI [2,3]
C0004781
UMLS CUI [3,1]
C0225990
UMLS CUI [3,2]
C0038454
UMLS CUI [3,3]
C0039729
UMLS CUI [4,1]
C0746408
UMLS CUI [4,2]
C0024485
UMLS CUI [5,1]
C0746408
UMLS CUI [5,2]
C0040405
5. participants in whom magnetic resonance imaging (mri) is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant.
Description

Medical contraindication Magnetic Resonance Imaging | Artificial cardiac pacemaker | Metal foreign body in eye region | Metallic material Spinal Cord | Cochlear Implants

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0030163
UMLS CUI [3]
C0562528
UMLS CUI [4,1]
C0567346
UMLS CUI [4,2]
C0037925
UMLS CUI [5]
C0009199
6. severe claustrophobia precluding mr or pet imaging. 7. subjects limited by previous participation in research procedures involving ionizing radiation.
Description

Claustrophobia Severe Excludes MRI | Claustrophobia Severe Excludes PET | Study Subject Participation Status Limited | Involvement with Ionizing radiation

Data type

boolean

Alias
UMLS CUI [1,1]
C0008909
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C0024485
UMLS CUI [2,1]
C0008909
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0332196
UMLS CUI [2,4]
C0032743
UMLS CUI [3,1]
C2348568
UMLS CUI [3,2]
C0439801
UMLS CUI [4,1]
C1314939
UMLS CUI [4,2]
C0034538
8. pregnancy (test within 48 hours of each pet session) or breastfeeding 9. history of deep brain stimulation surgery.
Description

Pregnancy Pregnancy Test | Breast Feeding | Deep Brain Stimulation

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0032976
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0394162
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Similar models

Eligibility Parkinson's Disease NCT02458430

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age 50 and above (m/f).
boolean
C0001779 (UMLS CUI [1])
Parkinson Disease | Mild cognitive disorder | Mild cognitive disorder Absent | Denervation Pattern Nigrostriate tract VMAT2 | Dementia Absent Neuropsychological Tests | UPDRS - Modified Hoehn and Yahr Staging
Item
2. pd diagnosis (with or without mild cognitive impairment; mci) will follow the uk parkinson's disease society brain bank research center (ukpdsbrc) clinical diagnostic criteria for pd (47), consistent with the typical nigrostriatal denervation pattern on vmat2. absence of significant dementia confirmed by neuropsychological testing. modified hoehn and yahr stages 1-4 (48, 49).
boolean
C0030567 (UMLS CUI [1])
C1270972 (UMLS CUI [2])
C1270972 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0011307 (UMLS CUI [4,1])
C0449774 (UMLS CUI [4,2])
C4323184 (UMLS CUI [4,3])
C0246932 (UMLS CUI [4,4])
C0497327 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0027902 (UMLS CUI [5,3])
C3639878 (UMLS CUI [6])
Progressive supranuclear palsy
Item
3. psp diagnosis will follow the ninds-psp clinical diagnostic criteria (50, 51).
boolean
C0038868 (UMLS CUI [1])
Denervation Dopaminergic Neurons Nigrostriate tract | (18F)FP-DTBZ
Item
4. all pd subjects will be required to have nigrostriatal dopaminergic denervation as demonstrated by [11c]dtbz pet imaging (52, 53). subjects with parkinsonism and absence of this pd-typical pattern will be re-categorized .
boolean
C0011307 (UMLS CUI [1,1])
C1512035 (UMLS CUI [1,2])
C4323184 (UMLS CUI [1,3])
C3661295 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Dementia | Disease Similar Parkinson Disease | Disease Similar Progressive supranuclear palsy | Lewy Body Disease | Dementia, Vascular | Hydrocephalus, Normal Pressure | Multiple System Atrophy | Corticobasal degeneration | Cause Toxic Parkinsonian Disorders
Item
1. presence of significant dementia. 2. disorders which may resemble pd or psp, such as dementia with lewy bodies, vascular dementia, normal pressure hydrocephalus, multiple system atrophy, corticobasal ganglionic degeneration, or toxic causes of parkinsonism. the use of the ukpdsbrc and ninds-psp clinical diagnostic criteria will mitigate the inclusion of patients with atypical parkinsonism.
boolean
C0497327 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C2348205 (UMLS CUI [2,2])
C0030567 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C2348205 (UMLS CUI [3,2])
C0038868 (UMLS CUI [3,3])
C0752347 (UMLS CUI [4])
C0011269 (UMLS CUI [5])
C0020258 (UMLS CUI [6])
C0393571 (UMLS CUI [7])
C0393570 (UMLS CUI [8])
C0015127 (UMLS CUI [9,1])
C1407029 (UMLS CUI [9,2])
C0242422 (UMLS CUI [9,3])
Antipsychotic Agents | Exception Quetiapine Low dose | Anticholinergic Agents | Trihexyphenidyl | Benztropine | Cholinesterase Inhibitors
Item
3. subjects on neuroleptic (except for low dose quetiapine 25-50 mg/d), anticholinergic (trihexyphenidyl, benztropine), cholinesterase inhibitors. subjects with prior exposure to disallowed medications may be eligible if there has been an interval of > 2 months off these medications.
boolean
C0040615 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0123091 (UMLS CUI [2,2])
C0445550 (UMLS CUI [2,3])
C0242896 (UMLS CUI [3])
C0041009 (UMLS CUI [4])
C0005098 (UMLS CUI [5])
C0008425 (UMLS CUI [6])
Large vessel Cerebrovascular accident Cerebral cortex | Large vessel Cerebrovascular accident Basal Ganglia | Large vessel Cerebrovascular accident Thalamus | Mass lesion MRI | Mass lesion CT
Item
4. evidence of a large vessel stroke in a clinically relevant area (cerebral cortex, basal ganglia, thalamus) or mass lesion on structural brain imaging (mri or ct).
boolean
C0225990 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
C0007776 (UMLS CUI [1,3])
C0225990 (UMLS CUI [2,1])
C0038454 (UMLS CUI [2,2])
C0004781 (UMLS CUI [2,3])
C0225990 (UMLS CUI [3,1])
C0038454 (UMLS CUI [3,2])
C0039729 (UMLS CUI [3,3])
C0746408 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
C0746408 (UMLS CUI [5,1])
C0040405 (UMLS CUI [5,2])
Medical contraindication Magnetic Resonance Imaging | Artificial cardiac pacemaker | Metal foreign body in eye region | Metallic material Spinal Cord | Cochlear Implants
Item
5. participants in whom magnetic resonance imaging (mri) is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant.
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
C0562528 (UMLS CUI [3])
C0567346 (UMLS CUI [4,1])
C0037925 (UMLS CUI [4,2])
C0009199 (UMLS CUI [5])
Claustrophobia Severe Excludes MRI | Claustrophobia Severe Excludes PET | Study Subject Participation Status Limited | Involvement with Ionizing radiation
Item
6. severe claustrophobia precluding mr or pet imaging. 7. subjects limited by previous participation in research procedures involving ionizing radiation.
boolean
C0008909 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0024485 (UMLS CUI [1,4])
C0008909 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0032743 (UMLS CUI [2,4])
C2348568 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C1314939 (UMLS CUI [4,1])
C0034538 (UMLS CUI [4,2])
Pregnancy Pregnancy Test | Breast Feeding | Deep Brain Stimulation
Item
8. pregnancy (test within 48 hours of each pet session) or breastfeeding 9. history of deep brain stimulation surgery.
boolean
C0032961 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
C0394162 (UMLS CUI [3])
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