ID

36785

Description

Pilot Study Evaluating Safety of Unilateral Gamma Knife Subthalamotomy for Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02249559

Link

https://clinicaltrials.gov/show/NCT02249559

Keywords

Versions (1)
  1. 6/8/19 6/8/19 -
Copyright Holder

See clinicaltrials.gov

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June 8, 2019

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License

Creative Commons BY 4.0
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Eligibility Parkinsons Disease NCT02249559

English

Eligibility Parkinsons Disease NCT02249559

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. otherwise appropriate dbs candidates but deemed suboptimal for dbs on account of one or more of the following:
Description

Patient Appropriate Deep Brain Stimulation | Patient Suboptimal Deep Brain Stimulation

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0394162
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C2984009
UMLS CUI [2,3]
C0394162
advanced age greater than 74 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
medical comorbidities
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
need for continual anticoagulation
Description

Patient need for Anticoagulation Therapy Continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0003281
UMLS CUI [1,3]
C0549178
poor candidates for general anesthesia based on cardiac, hepatic ,renal or pulmonary status
Description

General Anesthesia At risk Due to Cardiac Status | General Anesthesia At risk Due to Hepatic status | General Anesthesia At risk Due to Kidney problem | General Anesthesia At risk Due to Lung status

Data type

boolean

Alias
UMLS CUI [1,1]
C0002915
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C1999091
UMLS CUI [2,1]
C0002915
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0449925
UMLS CUI [3,1]
C0002915
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C0812426
UMLS CUI [4,1]
C0002915
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C0678226
UMLS CUI [4,4]
C0449930
high infection risk if internal dbs device hardware is placed (ie. poor diabetes mellitus control)
Description

High risk of Communicable Disease | Etiology Deep Brain Stimulation Device placement | Diabetes mellitus poor control

Data type

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0009450
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0394162
UMLS CUI [2,3]
C0021107
UMLS CUI [3]
C0860161
patient aversion to dbs
Description

Aversion Deep Brain Stimulation

Data type

boolean

Alias
UMLS CUI [1,1]
C0233496
UMLS CUI [1,2]
C0394162
2. patients with asymmetric disease symptoms including:
Description

Disease Symptoms Asymmetric

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0332514
rigidity
Description

Rigidity

Data type

boolean

Alias
UMLS CUI [1]
C0026837
tremor
Description

Tremor

Data type

boolean

Alias
UMLS CUI [1]
C0040822
bradykinesia
Description

Bradykinesia

Data type

boolean

Alias
UMLS CUI [1]
C0233565
dyskinesia
Description

Dyskinesia

Data type

boolean

Alias
UMLS CUI [1]
C0013384
3. more than 30% improvement in updrs score in on versus off medication state, except:
Description

Improvement Percentage UPDRS

Data type

boolean

Alias
UMLS CUI [1,1]
C2986411
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C3639721
in the presence of disabling contralateral dyskinesias/dystonia limiting dose tolerance
Description

Exception Dyskinesia Contralateral | Exception Dystonia Contralateral | Dose Tolerance Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0013384
UMLS CUI [1,3]
C0441988
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0013421
UMLS CUI [2,3]
C0441988
UMLS CUI [3,1]
C0178602
UMLS CUI [3,2]
C0231197
UMLS CUI [3,3]
C0439801
tremors that are medically refractory
Description

Tremors Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0040822
UMLS CUI [1,2]
C0205269
4. patients who are on a stable medication regimen and demonstrating stable disease symptoms (absence of significant improvement or deterioration) for at least 3 months at the time of gks, as determined by review of medical record
Description

Pharmacotherapy Stable | Symptoms Stable Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0205360
UMLS CUI [2,3]
C0449238
5. mmse score greater than or equal to 26
Description

Mini-mental state examination

Data type

boolean

Alias
UMLS CUI [1]
C0451306
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with prominent axial symptoms including postural instability and gait disturbances, defined as a score of 3 or greater on questions 28, 29 & 30 on the updrs
Description

Axial symptoms UPDRS | Postural instability UPDRS | Gait abnormality UPDRS

Data type

boolean

Alias
UMLS CUI [1,1]
C4314351
UMLS CUI [1,2]
C3639721
UMLS CUI [2,1]
C1843921
UMLS CUI [2,2]
C3639721
UMLS CUI [3,1]
C0575081
UMLS CUI [3,2]
C3639721
patients whose symptoms do not improve by more than 30% in updrs score with medication, unless patient experiences dose-limiting side effects
Description

Pharmacotherapy | Improvement Percentage UPDRS | Exception Side effects Limiting Dose

Data type

boolean

Alias
UMLS CUI [1]
C0013216
UMLS CUI [2,1]
C2986411
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C3639721
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0879626
UMLS CUI [3,3]
C0439801
UMLS CUI [3,4]
C0178602
the presence of dementia or inability to provide informed consent for participation in the study, as determined by a mini-mental status examination score below 25
Description

Dementia Mini-mental state examination | Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0451306
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
patients who have had prior brain radiation
Description

Radiotherapy to brain

Data type

boolean

Alias
UMLS CUI [1]
C0948319
patients with improvement and satisfactory symptom management will not be offered this procedure. we will only include patients without satisfactory symptom management.
Description

Improvement | Symptom Management satisfactory

Data type

boolean

Alias
UMLS CUI [1]
C2986411
UMLS CUI [2,1]
C1536570
UMLS CUI [2,2]
C0205410
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Similar models

Eligibility Parkinsons Disease NCT02249559

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patient Appropriate Deep Brain Stimulation | Patient Suboptimal Deep Brain Stimulation
Item
1. otherwise appropriate dbs candidates but deemed suboptimal for dbs on account of one or more of the following:
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0394162 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C2984009 (UMLS CUI [2,2])
C0394162 (UMLS CUI [2,3])
Age
Item
advanced age greater than 74 years of age
boolean
C0001779 (UMLS CUI [1])
Comorbidity
Item
medical comorbidities
boolean
C0009488 (UMLS CUI [1])
Patient need for Anticoagulation Therapy Continuous
Item
need for continual anticoagulation
boolean
C0686904 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
General Anesthesia At risk Due to Cardiac Status | General Anesthesia At risk Due to Hepatic status | General Anesthesia At risk Due to Kidney problem | General Anesthesia At risk Due to Lung status
Item
poor candidates for general anesthesia based on cardiac, hepatic ,renal or pulmonary status
boolean
C0002915 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C1999091 (UMLS CUI [1,4])
C0002915 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0449925 (UMLS CUI [2,4])
C0002915 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C0812426 (UMLS CUI [3,4])
C0002915 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0678226 (UMLS CUI [4,3])
C0449930 (UMLS CUI [4,4])
High risk of Communicable Disease | Etiology Deep Brain Stimulation Device placement | Diabetes mellitus poor control
Item
high infection risk if internal dbs device hardware is placed (ie. poor diabetes mellitus control)
boolean
C0332167 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0394162 (UMLS CUI [2,2])
C0021107 (UMLS CUI [2,3])
C0860161 (UMLS CUI [3])
Aversion Deep Brain Stimulation
Item
patient aversion to dbs
boolean
C0233496 (UMLS CUI [1,1])
C0394162 (UMLS CUI [1,2])
Disease Symptoms Asymmetric
Item
2. patients with asymmetric disease symptoms including:
boolean
C0012634 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0332514 (UMLS CUI [1,3])
Rigidity
Item
rigidity
boolean
C0026837 (UMLS CUI [1])
Tremor
Item
tremor
boolean
C0040822 (UMLS CUI [1])
Bradykinesia
Item
bradykinesia
boolean
C0233565 (UMLS CUI [1])
Dyskinesia
Item
dyskinesia
boolean
C0013384 (UMLS CUI [1])
Improvement Percentage UPDRS
Item
3. more than 30% improvement in updrs score in on versus off medication state, except:
boolean
C2986411 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C3639721 (UMLS CUI [1,3])
Exception Dyskinesia Contralateral | Exception Dystonia Contralateral | Dose Tolerance Limited
Item
in the presence of disabling contralateral dyskinesias/dystonia limiting dose tolerance
boolean
C1705847 (UMLS CUI [1,1])
C0013384 (UMLS CUI [1,2])
C0441988 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0013421 (UMLS CUI [2,2])
C0441988 (UMLS CUI [2,3])
C0178602 (UMLS CUI [3,1])
C0231197 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
Tremors Unresponsive to Treatment
Item
tremors that are medically refractory
boolean
C0040822 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
Pharmacotherapy Stable | Symptoms Stable Duration
Item
4. patients who are on a stable medication regimen and demonstrating stable disease symptoms (absence of significant improvement or deterioration) for at least 3 months at the time of gks, as determined by review of medical record
boolean
C0013216 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Mini-mental state examination
Item
5. mmse score greater than or equal to 26
boolean
C0451306 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Axial symptoms UPDRS | Postural instability UPDRS | Gait abnormality UPDRS
Item
patients with prominent axial symptoms including postural instability and gait disturbances, defined as a score of 3 or greater on questions 28, 29 & 30 on the updrs
boolean
C4314351 (UMLS CUI [1,1])
C3639721 (UMLS CUI [1,2])
C1843921 (UMLS CUI [2,1])
C3639721 (UMLS CUI [2,2])
C0575081 (UMLS CUI [3,1])
C3639721 (UMLS CUI [3,2])
Pharmacotherapy | Improvement Percentage UPDRS | Exception Side effects Limiting Dose
Item
patients whose symptoms do not improve by more than 30% in updrs score with medication, unless patient experiences dose-limiting side effects
boolean
C0013216 (UMLS CUI [1])
C2986411 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C3639721 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0879626 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C0178602 (UMLS CUI [3,4])
Dementia Mini-mental state examination | Informed Consent Unable
Item
the presence of dementia or inability to provide informed consent for participation in the study, as determined by a mini-mental status examination score below 25
boolean
C0497327 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Radiotherapy to brain
Item
patients who have had prior brain radiation
boolean
C0948319 (UMLS CUI [1])
Improvement | Symptom Management satisfactory
Item
patients with improvement and satisfactory symptom management will not be offered this procedure. we will only include patients without satisfactory symptom management.
boolean
C2986411 (UMLS CUI [1])
C1536570 (UMLS CUI [2,1])
C0205410 (UMLS CUI [2,2])
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