ID

18828

Descripción

Effects of Deep Brain Stimulation on Motor, Mood, and Cognitive Symptoms in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00360009

Link

https://clinicaltrials.gov/show/NCT00360009

Palabras clave

Versiones (1)
  1. 21/11/16 21/11/16 -
Subido en

21 de noviembre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Parkinson Disease NCT00360009

Inglés

Eligibility Parkinson Disease NCT00360009

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
intractable, disabling pd with motor fluctuations, dyskinesias, or freezing episodes
Descripción

Parkinson Disease disabling Unresponsive to Treatment | Motor fluctuations | Dyskinetic syndrome | Freezing of gait Episode of

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0596452
UMLS CUI [1,3]
C0205269
UMLS CUI [2]
C1868976
UMLS CUI [3]
C0013384
UMLS CUI [4,1]
C0860515
UMLS CUI [4,2]
C0332189
age between 30-75 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
unsatisfactory clinical response to maximal medical management (with trials of both higher and lower doses of anti-parkinsonian drugs)
Descripción

Antiparkinson Agents High dose | Antiparkinson Agents Low dose | Unresponsive to Treatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0444956
UMLS CUI [2,1]
C0003405
UMLS CUI [2,2]
C0445550
UMLS CUI [3]
C0205269
a stable and optimal medical regimen of anti-parkinsonian drug therapy for at least three months prior to surgery
Descripción

Antiparkinson Agents Optimal Stable Before Operative Surgical Procedure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C2698651
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0332152
UMLS CUI [1,5]
C0543467
patients must be right-handed to be included in the study since mood and cognition are being analyzed and right hemisphere dominant patients could confound the results.
Descripción

Handedness | assessment of mood | Assessment: Cognition

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023114
UMLS CUI [2]
C2237119
UMLS CUI [3]
C0870300
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically significant medical disease that would increase risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension)
Descripción

Disease Clinical Significance At risk Complication Preoperative | Disease Clinical Significance At risk Postoperative Complications | Heart Disease Significant | Lung disease Significant | Uncontrolled hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C0009566
UMLS CUI [1,5]
C0445204
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2826293
UMLS CUI [2,3]
C1444641
UMLS CUI [2,4]
C0032787
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0750502
UMLS CUI [4,1]
C0024115
UMLS CUI [4,2]
C0750502
UMLS CUI [5]
C1868885
evidence of secondary or atypical parkinsonism as suggested by the presence of any of the following: 1) history of stroke(s), 2) exposure to toxins or neuroleptics, 3) history of encephalitis, 4) neurological signs of upper motor neuron disease, cerebellar involvement, supranuclear gaze palsy, or significant orthostatic hypotension
Descripción

Secondary Parkinson Disease | Parkinsonian Disorders Atypical | Cerebrovascular accident Quantity | Exposure to toxin | Antipsychotic Agents Exposure to | Encephalitis | Upper Motor Neuron Disease Neurologic Signs | Involvement Cerebellar | Supranuclear gaze palsy | Hypotension orthostatic Significant

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030569
UMLS CUI [2,1]
C0242422
UMLS CUI [2,2]
C0205182
UMLS CUI [3,1]
C0038454
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C0040537
UMLS CUI [5,1]
C0040615
UMLS CUI [5,2]
C0332157
UMLS CUI [6]
C0014038
UMLS CUI [7,1]
C0521659
UMLS CUI [7,2]
C0751378
UMLS CUI [8,1]
C1314939
UMLS CUI [8,2]
C0007765
UMLS CUI [9]
C1720037
UMLS CUI [10,1]
C0020651
UMLS CUI [10,2]
C0750502
mri scan with significant evidence of brain atrophy or other abnormalities (e.g., lacunar infarcts or iron deposits in the putamen)
Descripción

MRI Scans | Cerebral atrophy Evidence Significant | Abnormality Evidence Significant | Infarction, Lacunar | Iron Deposits putamen

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0917711
UMLS CUI [2,1]
C0235946
UMLS CUI [2,2]
C3887511
UMLS CUI [2,3]
C0750502
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C3887511
UMLS CUI [3,3]
C0750502
UMLS CUI [4]
C0333559
UMLS CUI [5,1]
C0302583
UMLS CUI [5,2]
C0333562
UMLS CUI [5,3]
C1281335
the mattis dementia rating scale will be used to assess the level of intellectual function and patients will be excluded with scores reflecting clinical dementia
Descripción

Clinical dementia rating scale | Dementia Clinical

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0451074
UMLS CUI [2,1]
C0497327
UMLS CUI [2,2]
C0205210
a major psychiatric disorder on the structured clinical interview for dsm-iv (scid-iv).
Descripción

Mental disorder Major

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205164
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Similar models

Eligibility Parkinson Disease NCT00360009

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease disabling Unresponsive to Treatment | Motor fluctuations | Dyskinetic syndrome | Freezing of gait Episode of
Item
intractable, disabling pd with motor fluctuations, dyskinesias, or freezing episodes
boolean
C0030567 (UMLS CUI [1,1])
C0596452 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
C1868976 (UMLS CUI [2])
C0013384 (UMLS CUI [3])
C0860515 (UMLS CUI [4,1])
C0332189 (UMLS CUI [4,2])
Age
Item
age between 30-75 years
boolean
C0001779 (UMLS CUI [1])
Antiparkinson Agents High dose | Antiparkinson Agents Low dose | Unresponsive to Treatment
Item
unsatisfactory clinical response to maximal medical management (with trials of both higher and lower doses of anti-parkinsonian drugs)
boolean
C0003405 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C0003405 (UMLS CUI [2,1])
C0445550 (UMLS CUI [2,2])
C0205269 (UMLS CUI [3])
Antiparkinson Agents Optimal Stable Before Operative Surgical Procedure
Item
a stable and optimal medical regimen of anti-parkinsonian drug therapy for at least three months prior to surgery
boolean
C0003405 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0543467 (UMLS CUI [1,5])
Handedness | assessment of mood | Assessment: Cognition
Item
patients must be right-handed to be included in the study since mood and cognition are being analyzed and right hemisphere dominant patients could confound the results.
boolean
C0023114 (UMLS CUI [1])
C2237119 (UMLS CUI [2])
C0870300 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Disease Clinical Significance At risk Complication Preoperative | Disease Clinical Significance At risk Postoperative Complications | Heart Disease Significant | Lung disease Significant | Uncontrolled hypertension
Item
clinically significant medical disease that would increase risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension)
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0009566 (UMLS CUI [1,4])
C0445204 (UMLS CUI [1,5])
C0012634 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0032787 (UMLS CUI [2,4])
C0018799 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
C0024115 (UMLS CUI [4,1])
C0750502 (UMLS CUI [4,2])
C1868885 (UMLS CUI [5])
Secondary Parkinson Disease | Parkinsonian Disorders Atypical | Cerebrovascular accident Quantity | Exposure to toxin | Antipsychotic Agents Exposure to | Encephalitis | Upper Motor Neuron Disease Neurologic Signs | Involvement Cerebellar | Supranuclear gaze palsy | Hypotension orthostatic Significant
Item
evidence of secondary or atypical parkinsonism as suggested by the presence of any of the following: 1) history of stroke(s), 2) exposure to toxins or neuroleptics, 3) history of encephalitis, 4) neurological signs of upper motor neuron disease, cerebellar involvement, supranuclear gaze palsy, or significant orthostatic hypotension
boolean
C0030569 (UMLS CUI [1])
C0242422 (UMLS CUI [2,1])
C0205182 (UMLS CUI [2,2])
C0038454 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0040537 (UMLS CUI [4])
C0040615 (UMLS CUI [5,1])
C0332157 (UMLS CUI [5,2])
C0014038 (UMLS CUI [6])
C0521659 (UMLS CUI [7,1])
C0751378 (UMLS CUI [7,2])
C1314939 (UMLS CUI [8,1])
C0007765 (UMLS CUI [8,2])
C1720037 (UMLS CUI [9])
C0020651 (UMLS CUI [10,1])
C0750502 (UMLS CUI [10,2])
MRI Scans | Cerebral atrophy Evidence Significant | Abnormality Evidence Significant | Infarction, Lacunar | Iron Deposits putamen
Item
mri scan with significant evidence of brain atrophy or other abnormalities (e.g., lacunar infarcts or iron deposits in the putamen)
boolean
C0917711 (UMLS CUI [1])
C0235946 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
C1704258 (UMLS CUI [3,1])
C3887511 (UMLS CUI [3,2])
C0750502 (UMLS CUI [3,3])
C0333559 (UMLS CUI [4])
C0302583 (UMLS CUI [5,1])
C0333562 (UMLS CUI [5,2])
C1281335 (UMLS CUI [5,3])
Clinical dementia rating scale | Dementia Clinical
Item
the mattis dementia rating scale will be used to assess the level of intellectual function and patients will be excluded with scores reflecting clinical dementia
boolean
C0451074 (UMLS CUI [1])
C0497327 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
Mental disorder Major
Item
a major psychiatric disorder on the structured clinical interview for dsm-iv (scid-iv).
boolean
C0004936 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
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