ID

36753

Description

Can tDCS Enhance Efficacy of Rehabilitative Intervention for Freezing of Gait in Parkinson's Disease?; ODM derived from: https://clinicaltrials.gov/show/NCT02205216

Lien

https://clinicaltrials.gov/show/NCT02205216

Mots-clés

Versions (1)
  1. 06/06/2019 06/06/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

6 juin 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Parkinson Disease NCT02205216

Anglais

Eligibility Parkinson Disease NCT02205216

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women aged 30 to 80 years with dopa-responsive pd hoehn and yahr (hy) grade of 2 to 4 while "off"
Description

Age | Parkinson Disease Hoehn and Yahr grades | Parkinson Disease Dopa Responsive

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0030567
UMLS CUI [2,2]
C0451215
UMLS CUI [3,1]
C0030567
UMLS CUI [3,2]
C0013023
UMLS CUI [3,3]
C0205342
must be on a regimen including levodopa
Description

Therapeutic procedure | Levodopa

Type de données

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2]
C0023570
total dose of levodopa and dopamine agonists (using dopamine equivalents) has to be equal to or more than 300 milligrams per day
Description

Levodopa Cumulative Dose per day | Dopamine Agonists Cumulative Dose per day

Type de données

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C2986497
UMLS CUI [1,3]
C0439505
UMLS CUI [2,1]
C0178601
UMLS CUI [2,2]
C2986497
UMLS CUI [2,3]
C0439505
gait difficulties with freezing of gait as defined by mds-updrs i score ≥ 2 in fog
Description

Gait abnormality | Freezing of gait MDS-UPDRS

Type de données

boolean

Alias
UMLS CUI [1]
C0575081
UMLS CUI [2,1]
C0860515
UMLS CUI [2,2]
C3639714
optimal conventional pd medication for > 1 month prior to screening
Description

Pharmaceutical Preparations Optimal Parkinson Disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2698651
UMLS CUI [1,3]
C0030567
scheduled for rehabilitative intervention for the treatment of freezing of gait
Description

Rehabilitation therapy Scheduled Freezing of gait

Type de données

boolean

Alias
UMLS CUI [1,1]
C0034991
UMLS CUI [1,2]
C0205539
UMLS CUI [1,3]
C0860515
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant concurrent medical or psychiatric disease
Description

Comorbidity | Mental disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0004936
history of seizures and epilepsy
Description

Seizures | Epilepsy

Type de données

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2]
C0014544
dementia or other neurodegenerative disease (besides pd)
Description

Dementia | Neurodegenerative Disorders | In addition to Parkinson Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C0524851
UMLS CUI [3,1]
C0332287
UMLS CUI [3,2]
C0030567
pallidotomy, implanted electrodes and generator for deep brain stimulation
Description

Pallidotomy | Electrodes, Implanted | Deep brain stimulation generator

Type de données

boolean

Alias
UMLS CUI [1]
C0195893
UMLS CUI [2]
C0013814
UMLS CUI [3]
C4075668
pregnancy
Description

Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
surgically or traumatically implanted foreign bodies such as an implanted medical pump, implanted hearing aids, metal plate in the skull, or metal implant in the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during tdcs.
Description

Foreign Bodies Implanted | Pump Implanted | Hearing Aids Implanted | Metal plate Skull | Plates, Cranioplasty | Ophthalmological implant Metallic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0016542
UMLS CUI [1,2]
C0021102
UMLS CUI [2,1]
C0182537
UMLS CUI [2,2]
C0021102
UMLS CUI [3,1]
C0018768
UMLS CUI [3,2]
C0021102
UMLS CUI [4,1]
C0013866
UMLS CUI [4,2]
C2951888
UMLS CUI [5]
C0182313
UMLS CUI [6,1]
C0581278
UMLS CUI [6,2]
C2986473
study would cause undue risk or stress for reasons such as tendency to fall, excessive fatigue, general frailty, or excessive apprehensiveness.
Description

Study Subject Participation Status At risk | Tendency to fall | Fatigue Excessive | Frailty General | Apprehensiveness Excessive

Type de données

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1444641
UMLS CUI [2]
C2830327
UMLS CUI [3,1]
C0015672
UMLS CUI [3,2]
C0442802
UMLS CUI [4,1]
C0424594
UMLS CUI [4,2]
C0205246
UMLS CUI [5,1]
C0233485
UMLS CUI [5,2]
C0442802
significant postural instability with daily falls, inability to walk the parcours or inability to walk 10 meters.
Description

Postural instability | Falls Daily | Lacking Able to walk Distance

Type de données

boolean

Alias
UMLS CUI [1]
C1843921
UMLS CUI [2,1]
C0085639
UMLS CUI [2,2]
C0332173
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C2712089
UMLS CUI [3,3]
C0429886
presence of significant cognitive dysfunction as determined by montreal cognitive assessment (moca) <20 or mentally impaired patients having no capacity to provide their own consent (the physician establishing the diagnosis and applying updrs will evaluate patient's mental capacity using conventional clinical interview).
Description

Impaired cognition MoCA questionnaire total score | Mental impairment | Informed Consent Unable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0338656
UMLS CUI [1,2]
C3836787
UMLS CUI [2]
C0683322
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1299582
presence of other co-morbid conditions that can contribute to gait dysfunction (orthopedic, rheumatologic, cardiac, other)
Description

Comorbidity Contributing Gait Dysfunction | Musculoskeletal Disease | Rheumatic disorder | Heart Disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1880177
UMLS CUI [1,3]
C0751830
UMLS CUI [2]
C0026857
UMLS CUI [3]
C3495832
UMLS CUI [4]
C0018799
presence of clinically significant hallucinations
Description

Hallucinations

Type de données

boolean

Alias
UMLS CUI [1]
C0018524
participation in any rehabilitation therapy for fog within the last six months prior to screening
Description

Rehabilitation therapy Freezing of gait

Type de données

boolean

Alias
UMLS CUI [1,1]
C0034991
UMLS CUI [1,2]
C0860515
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Similar models

Eligibility Parkinson Disease NCT02205216

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age | Parkinson Disease Hoehn and Yahr grades | Parkinson Disease Dopa Responsive
Item
men and women aged 30 to 80 years with dopa-responsive pd hoehn and yahr (hy) grade of 2 to 4 while "off"
boolean
C0001779 (UMLS CUI [1])
C0030567 (UMLS CUI [2,1])
C0451215 (UMLS CUI [2,2])
C0030567 (UMLS CUI [3,1])
C0013023 (UMLS CUI [3,2])
C0205342 (UMLS CUI [3,3])
Therapeutic procedure | Levodopa
Item
must be on a regimen including levodopa
boolean
C0087111 (UMLS CUI [1])
C0023570 (UMLS CUI [2])
Levodopa Cumulative Dose per day | Dopamine Agonists Cumulative Dose per day
Item
total dose of levodopa and dopamine agonists (using dopamine equivalents) has to be equal to or more than 300 milligrams per day
boolean
C0023570 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
C0178601 (UMLS CUI [2,1])
C2986497 (UMLS CUI [2,2])
C0439505 (UMLS CUI [2,3])
Gait abnormality | Freezing of gait MDS-UPDRS
Item
gait difficulties with freezing of gait as defined by mds-updrs i score ≥ 2 in fog
boolean
C0575081 (UMLS CUI [1])
C0860515 (UMLS CUI [2,1])
C3639714 (UMLS CUI [2,2])
Pharmaceutical Preparations Optimal Parkinson Disease
Item
optimal conventional pd medication for > 1 month prior to screening
boolean
C0013227 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
Rehabilitation therapy Scheduled Freezing of gait
Item
scheduled for rehabilitative intervention for the treatment of freezing of gait
boolean
C0034991 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0860515 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Comorbidity | Mental disorders
Item
significant concurrent medical or psychiatric disease
boolean
C0009488 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Seizures | Epilepsy
Item
history of seizures and epilepsy
boolean
C0036572 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
Dementia | Neurodegenerative Disorders | In addition to Parkinson Disease
Item
dementia or other neurodegenerative disease (besides pd)
boolean
C0497327 (UMLS CUI [1])
C0524851 (UMLS CUI [2])
C0332287 (UMLS CUI [3,1])
C0030567 (UMLS CUI [3,2])
Pallidotomy | Electrodes, Implanted | Deep brain stimulation generator
Item
pallidotomy, implanted electrodes and generator for deep brain stimulation
boolean
C0195893 (UMLS CUI [1])
C0013814 (UMLS CUI [2])
C4075668 (UMLS CUI [3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Foreign Bodies Implanted | Pump Implanted | Hearing Aids Implanted | Metal plate Skull | Plates, Cranioplasty | Ophthalmological implant Metallic
Item
surgically or traumatically implanted foreign bodies such as an implanted medical pump, implanted hearing aids, metal plate in the skull, or metal implant in the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during tdcs.
boolean
C0016542 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
C0182537 (UMLS CUI [2,1])
C0021102 (UMLS CUI [2,2])
C0018768 (UMLS CUI [3,1])
C0021102 (UMLS CUI [3,2])
C0013866 (UMLS CUI [4,1])
C2951888 (UMLS CUI [4,2])
C0182313 (UMLS CUI [5])
C0581278 (UMLS CUI [6,1])
C2986473 (UMLS CUI [6,2])
Study Subject Participation Status At risk | Tendency to fall | Fatigue Excessive | Frailty General | Apprehensiveness Excessive
Item
study would cause undue risk or stress for reasons such as tendency to fall, excessive fatigue, general frailty, or excessive apprehensiveness.
boolean
C2348568 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C2830327 (UMLS CUI [2])
C0015672 (UMLS CUI [3,1])
C0442802 (UMLS CUI [3,2])
C0424594 (UMLS CUI [4,1])
C0205246 (UMLS CUI [4,2])
C0233485 (UMLS CUI [5,1])
C0442802 (UMLS CUI [5,2])
Postural instability | Falls Daily | Lacking Able to walk Distance
Item
significant postural instability with daily falls, inability to walk the parcours or inability to walk 10 meters.
boolean
C1843921 (UMLS CUI [1])
C0085639 (UMLS CUI [2,1])
C0332173 (UMLS CUI [2,2])
C0332268 (UMLS CUI [3,1])
C2712089 (UMLS CUI [3,2])
C0429886 (UMLS CUI [3,3])
Impaired cognition MoCA questionnaire total score | Mental impairment | Informed Consent Unable
Item
presence of significant cognitive dysfunction as determined by montreal cognitive assessment (moca) <20 or mentally impaired patients having no capacity to provide their own consent (the physician establishing the diagnosis and applying updrs will evaluate patient's mental capacity using conventional clinical interview).
boolean
C0338656 (UMLS CUI [1,1])
C3836787 (UMLS CUI [1,2])
C0683322 (UMLS CUI [2])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Comorbidity Contributing Gait Dysfunction | Musculoskeletal Disease | Rheumatic disorder | Heart Disease
Item
presence of other co-morbid conditions that can contribute to gait dysfunction (orthopedic, rheumatologic, cardiac, other)
boolean
C0009488 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
C0751830 (UMLS CUI [1,3])
C0026857 (UMLS CUI [2])
C3495832 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
Hallucinations
Item
presence of clinically significant hallucinations
boolean
C0018524 (UMLS CUI [1])
Rehabilitation therapy Freezing of gait
Item
participation in any rehabilitation therapy for fog within the last six months prior to screening
boolean
C0034991 (UMLS CUI [1,1])
C0860515 (UMLS CUI [1,2])
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