ID

17239

Description

Safety and Efficacy of Motor Cortex Stimulation in the Treatment of Advanced Parkinson Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00159172

Link

https://clinicaltrials.gov/show/NCT00159172

Keywords

  1. 9/1/16 9/1/16 -
Uploaded on

September 1, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Parkinson Disease NCT00159172

Eligibility Parkinson Disease NCT00159172

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age between 18 and 70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
idiopathic parkinson disease, for at least 5 years of evolution
Description

Idiopathic parkinson disease

Data type

boolean

Alias
UMLS CUI [1]
C0030567
asymmetric akinetic-rigid form, with symptoms predominant in the right side of the body (stimulator will be implanted on the left side).
Description

asymmetric akinetic-rigid form, with symptoms predominant in the right side of the body

Data type

boolean

Alias
UMLS CUI [1]
C1446219
UMLS CUI [2,1]
C0030567
UMLS CUI [2,2]
C0332514
UMLS CUI [2,3]
C0229966
functional impairment score in off stage (no drug treatment) of 3-4 according to the hoehn and yahr scale
Description

Hoehn and yahr scale

Data type

boolean

Alias
UMLS CUI [1]
C0451215
updrs iii score > 40 in off-drug stage.
Description

UPDRS

Data type

boolean

Alias
UMLS CUI [1]
C3639721
updrs iii score with l-dopa treatment improved by at least 50% compared to updrs iii score in off-drug stage
Description

updrs iii score with l-dopa treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C3639721
UMLS CUI [1,2]
C0023570
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
age superior to 70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
adult patients under guardianship
Description

under guardianship

Data type

boolean

Alias
UMLS CUI [1]
C0870627
previous neurosurgical operation(s)
Description

Neurosurgical operation

Data type

boolean

Alias
UMLS CUI [1]
C0524850
previous partial or generalised seizures
Description

Seizures

Data type

boolean

Alias
UMLS CUI [1]
C0036572
mini mental status (mms) score  24 or mattis score < 130 or montgomery-asberg depression rating scale (madrs) depression score > 20.
Description

mini mental status score, dementia, montgomery-asberg depression rating scale score

Data type

boolean

Alias
UMLS CUI [1]
C0451306
UMLS CUI [2]
C0497327
UMLS CUI [3]
C4054475
presence of signal abnormalities on t1- and t2- mri sequences
Description

signal abnormalities on t1- and t2- mri sequences

Data type

boolean

Alias
UMLS CUI [1]
C1319851
abnormalities in general exam or biological constants (hemogram, ionogram, hepatic or kidney dysfunction) with a higher surgical risk
Description

abnormalities in general exam or biological constants

Data type

boolean

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0200631
UMLS CUI [3]
C0853360
UMLS CUI [4]
C0232741
UMLS CUI [5]
C0022662

Similar models

Eligibility Parkinson Disease NCT00159172

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age between 18 and 70 years
boolean
C0001779 (UMLS CUI [1])
Idiopathic parkinson disease
Item
idiopathic parkinson disease, for at least 5 years of evolution
boolean
C0030567 (UMLS CUI [1])
asymmetric akinetic-rigid form, with symptoms predominant in the right side of the body
Item
asymmetric akinetic-rigid form, with symptoms predominant in the right side of the body (stimulator will be implanted on the left side).
boolean
C1446219 (UMLS CUI [1])
C0030567 (UMLS CUI [2,1])
C0332514 (UMLS CUI [2,2])
C0229966 (UMLS CUI [2,3])
Hoehn and yahr scale
Item
functional impairment score in off stage (no drug treatment) of 3-4 according to the hoehn and yahr scale
boolean
C0451215 (UMLS CUI [1])
UPDRS
Item
updrs iii score > 40 in off-drug stage.
boolean
C3639721 (UMLS CUI [1])
updrs iii score with l-dopa treatment
Item
updrs iii score with l-dopa treatment improved by at least 50% compared to updrs iii score in off-drug stage
boolean
C3639721 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
age superior to 70 years
boolean
C0001779 (UMLS CUI [1])
under guardianship
Item
adult patients under guardianship
boolean
C0870627 (UMLS CUI [1])
Neurosurgical operation
Item
previous neurosurgical operation(s)
boolean
C0524850 (UMLS CUI [1])
Seizures
Item
previous partial or generalised seizures
boolean
C0036572 (UMLS CUI [1])
mini mental status score, dementia, montgomery-asberg depression rating scale score
Item
mini mental status (mms) score  24 or mattis score < 130 or montgomery-asberg depression rating scale (madrs) depression score > 20.
boolean
C0451306 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
C4054475 (UMLS CUI [3])
signal abnormalities on t1- and t2- mri sequences
Item
presence of signal abnormalities on t1- and t2- mri sequences
boolean
C1319851 (UMLS CUI [1])
abnormalities in general exam or biological constants
Item
abnormalities in general exam or biological constants (hemogram, ionogram, hepatic or kidney dysfunction) with a higher surgical risk
boolean
C0031809 (UMLS CUI [1])
C0200631 (UMLS CUI [2])
C0853360 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
C0022662 (UMLS CUI [5])

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