ID

42531

Beschreibung

Pedunculo-Pontin Nucleus (PPN) - Deep Brain Stimulation (DBS) in Gait and Balance Disturbance in Parkinson's Disease (PPN-GAB-PARK Study); ODM derived from: https://clinicaltrials.gov/show/NCT00821743

Link

https://clinicaltrials.gov/show/NCT00821743

Stichworte

Versionen (1)
  1. 18.08.21 18.08.21 -
Rechteinhaber

Centre Hospitalier Universitaire de Nice

Hochgeladen am

18. August 2021

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Eligibility Parkinson Disease NCT00821743

Englisch

Eligibility Parkinson Disease NCT00821743

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
severe idiopathic parkinson's disease (stage of hoehn and yahr ≥ 3).
Beschreibung

Severe idiopathic parkinson's disease (Hoehn and Yahr Stage)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0865475
UMLS CUI [1,2]
C3639483
UMLS CUI [1,3]
C0205082
disease duration ≥ 5 years.
Beschreibung

Disease duration

Datentyp

boolean

Alias
UMLS CUI [1]
C0872146
predominant axial motor signs (gait and balance disturbance as freezing of gait, postural instability, falls) with disability in daily life, defined by a score updrs ii 2 of item 13 or 3 of item 14 or 15.
Beschreibung

Predominant axial motor signs | Gait disturbance | Balance ability absent | UPRDS score

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0426980
UMLS CUI [1,2]
C0205131
UMLS CUI [1,3]
C1542147
UMLS CUI [2,1]
C0560184
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C1856566
UMLS CUI [4]
C3639721
axial motor signs resistant to optimal drug and non-drug treatment, including physical therapy and eventually stn-dbs (if stn-dbs is ongoing for at least 1 year and has shown no efficacy on axial motor signs).
Beschreibung

Axial motor signs resistant to treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0426980
UMLS CUI [1,2]
C0205131
UMLS CUI [1,3]
C0205269
no significant abnormality on brain mri.
Beschreibung

Significant abnormality on brain MRI absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0412675
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0750502
UMLS CUI [1,4]
C0332197
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
patient with non-axial, dopa-responsive motor signs and indication of first line stn-dbs. in case of absence of efficacy of stn-dbs on axial motor signs after one year of stimulation, ppn-dbs may be proposed to these patients.
Beschreibung

Non-axial, dopa-responsive motor signs | Indication of first line stn-dbs | When absence of efficacy of stn-dbs after one year, pps-dbs allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0426980
UMLS CUI [1,2]
C1705847
UMLS CUI [1,3]
C0205131
UMLS CUI [1,4]
C0023570
UMLS CUI [1,5]
C0205342
UMLS CUI [2,1]
C0152355
UMLS CUI [2,2]
C0394162
UMLS CUI [2,3]
C1708063
UMLS CUI [2,4]
C3146298
UMLS CUI [3,1]
C0152355
UMLS CUI [3,2]
C0394162
UMLS CUI [3,3]
C0235828
UMLS CUI [3,4]
C0449238
UMLS CUI [3,5]
C0683607
UMLS CUI [3,6]
C0262306
UMLS CUI [3,7]
C0394162
patient with major cognitive disturbances defined by a score mattis drs 130 (of 144).
Beschreibung

Impaired cognition defined by Clinical dementia rating scale

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0338656
UMLS CUI [1,2]
C0451074
pregnant or breast-feeding woman.
Beschreibung

Pregnancy | Breast-feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient with contraindication for general anaesthesia, a contraindication for surgery (including disorders of haemostasis, or necessity of anticoagulant and antiaggregant drug), or a contraindication for mri.
Beschreibung

Contraindication for general anaesthesia | Contraindication for surgery | Contraindication for mri.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002915
UMLS CUI [1,2]
C1301624
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C1301624
UMLS CUI [3,1]
C0024485
UMLS CUI [3,2]
C1301624
patient presenting major depression, psychosis or addiction in six months preceding inclusion.
Beschreibung

Major depression recent | Psychosis recent | Addiction recent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0033975
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C0038586
UMLS CUI [3,2]
C0332185
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Ähnliche Modelle

Eligibility Parkinson Disease NCT00821743

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Severe idiopathic parkinson's disease (Hoehn and Yahr Stage)
Item
severe idiopathic parkinson's disease (stage of hoehn and yahr ≥ 3).
boolean
C0865475 (UMLS CUI [1,1])
C3639483 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Disease duration
Item
disease duration ≥ 5 years.
boolean
C0872146 (UMLS CUI [1])
Predominant axial motor signs | Gait disturbance | Balance ability absent | UPRDS score
Item
predominant axial motor signs (gait and balance disturbance as freezing of gait, postural instability, falls) with disability in daily life, defined by a score updrs ii 2 of item 13 or 3 of item 14 or 15.
boolean
C0426980 (UMLS CUI [1,1])
C0205131 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
C0560184 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1856566 (UMLS CUI [3])
C3639721 (UMLS CUI [4])
Axial motor signs resistant to treatment
Item
axial motor signs resistant to optimal drug and non-drug treatment, including physical therapy and eventually stn-dbs (if stn-dbs is ongoing for at least 1 year and has shown no efficacy on axial motor signs).
boolean
C0426980 (UMLS CUI [1,1])
C0205131 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
Significant abnormality on brain MRI absent
Item
no significant abnormality on brain mri.
boolean
C0412675 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Non-axial, dopa-responsive motor signs | Indication of first line stn-dbs | When absence of efficacy of stn-dbs after one year, pps-dbs allowed
Item
patient with non-axial, dopa-responsive motor signs and indication of first line stn-dbs. in case of absence of efficacy of stn-dbs on axial motor signs after one year of stimulation, ppn-dbs may be proposed to these patients.
boolean
C0426980 (UMLS CUI [1,1])
C1705847 (UMLS CUI [1,2])
C0205131 (UMLS CUI [1,3])
C0023570 (UMLS CUI [1,4])
C0205342 (UMLS CUI [1,5])
C0152355 (UMLS CUI [2,1])
C0394162 (UMLS CUI [2,2])
C1708063 (UMLS CUI [2,3])
C3146298 (UMLS CUI [2,4])
C0152355 (UMLS CUI [3,1])
C0394162 (UMLS CUI [3,2])
C0235828 (UMLS CUI [3,3])
C0449238 (UMLS CUI [3,4])
C0683607 (UMLS CUI [3,5])
C0262306 (UMLS CUI [3,6])
C0394162 (UMLS CUI [3,7])
Impaired cognition defined by Clinical dementia rating scale
Item
patient with major cognitive disturbances defined by a score mattis drs 130 (of 144).
boolean
C0338656 (UMLS CUI [1,1])
C0451074 (UMLS CUI [1,2])
Pregnancy | Breast-feeding
Item
pregnant or breast-feeding woman.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraindication for general anaesthesia | Contraindication for surgery | Contraindication for mri.
Item
patient with contraindication for general anaesthesia, a contraindication for surgery (including disorders of haemostasis, or necessity of anticoagulant and antiaggregant drug), or a contraindication for mri.
boolean
C0002915 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
C0024485 (UMLS CUI [3,1])
C1301624 (UMLS CUI [3,2])
Major depression recent | Psychosis recent | Addiction recent
Item
patient presenting major depression, psychosis or addiction in six months preceding inclusion.
boolean
C1269683 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0033975 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0038586 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
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