ID

12041

Beschrijving

A Responsive Closed-Loop Approach to Treat Freezing of Gait in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02318927

Link

https://clinicaltrials.gov/show/NCT02318927

Trefwoorden

Versies (1)
  1. 02-09-15 02-09-15 -
Geüploaded op

2 september 2015

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Parkinsons Disease NCT02318927

Engels

Eligibility Parkinsons Disease NCT02318927

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. A clinical diagnosis of idiopathic PD, without a previous DBS operation
Beschrijving

1. A clinical diagnosis of idiopathic PD, without a previous DBS operation

Datatype

boolean

Alias
UMLS CUI [1]
C0865475
2. Must be deemed appropriate for a GPi DBS operation by the interdisciplinary screening team (GPi must be the target chosen as most appropriate for treatment of their PD to qualify for this study)
Beschrijving

2. Must be deemed appropriate for a GPi DBS operation by the interdisciplinary screening team (GPi must be the target chosen as most appropriate for treatment of their PD to qualify for this study)

Datatype

boolean

Alias
UMLS CUI [1]
C0394162
UMLS CUI [2]
C0543467
3. Age 30-75 years (must meet UK Brain Bank criteria for diagnosis of idiopathic Parkinson's disease).
Beschrijving

3. Age 30-75 years (must meet UK Brain Bank criteria for diagnosis of idiopathic Parkinson's disease).

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
4. Experiencing significant gait and postural instability despite optimal pharmacologic management (Hoehn and Yahr Stage II or greater in the on state).
Beschrijving

4. Experiencing significant gait and postural instability despite optimal pharmacologic management (Hoehn and Yahr Stage II or greater in the on state).

Datatype

boolean

Alias
UMLS CUI [1]
C0016928
5. Best medication "on" does not reveal meaningful improvement in posture scores (Pull Test). Patients must be challenged in person with a suprathreshold dose of levodopa (1.5 times optimized regular dose of levodopa) and must have poor or no improvement in postural stability.
Beschrijving

5. Best medication "on" does not reveal meaningful improvement in posture scores (Pull Test). Patients must be challenged in person with a suprathreshold dose of levodopa (1.5 times optimized regular dose of levodopa) and must have poor or no improvement in postural stability.

Datatype

boolean

Alias
UMLS CUI [1]
C3166208
6. Patients must possess a clinical history of gait freezing > 2 episodes per month, to be included, participants must also score > 1 on item #3 of the Freezing of Gait (FOG) Questionnaire and exhibit five or more FoG episodes during the provocation protocol in on or off state.
Beschrijving

6. Patients must possess a clinical history of gait freezing > 2 episodes per month, to be included, participants must also score > 1 on item #3 of the Freezing of Gait (FOG) Questionnaire and exhibit five or more FoG episodes during the provocation protocol in on or off state.

Datatype

boolean

Alias
UMLS CUI [1]
C0860515
7. L-dopa responsive with clearly defined "on" periods.
Beschrijving

7. L-dopa responsive with clearly defined "on" periods.

Datatype

boolean

Alias
UMLS CUI [1]
C0023570
UMLS CUI [2]
C0205342
8. Willingness and ability to cooperate during conscious operative procedure, as well as during post-surgical evaluations, adjustments of medications and stimulator settings.
Beschrijving

8. Willingness and ability to cooperate during conscious operative procedure, as well as during post-surgical evaluations, adjustments of medications and stimulator settings.

Datatype

boolean

Alias
UMLS CUI [1]
C0392337
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
1. Clinically significant medical disease that would increase the risk of developing pre- or postoperative complications. Clinically significant medical disease includes uncontrolled systemic hypertension with values above 170/100mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation which cannot be interrupted; any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician.
Beschrijving

1. Clinically significant medical disease that would increase the risk of developing pre- or postoperative complications. Clinically significant medical disease includes uncontrolled systemic hypertension with values above 170/100mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation which cannot be interrupted; any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician.

Datatype

boolean

Alias
UMLS CUI [1]
C0750502
UMLS CUI [2]
C0012634
2. Evidence of secondary or atypical parkinsonism.
Beschrijving

2. Evidence of secondary or atypical parkinsonism.

Datatype

boolean

Alias
UMLS CUI [1]
C0030569
3. Other neurological and musculoskeletal impairments that would negatively influence postural stability
Beschrijving

3. Other neurological and musculoskeletal impairments that would negatively influence postural stability

Datatype

boolean

Alias
UMLS CUI [1]
C0848778
UMLS CUI [2]
C0521654
4. Past MRI scan with significant evidence of brain atrophy or other abnormalities.
Beschrijving

4. Past MRI scan with significant evidence of brain atrophy or other abnormalities.

Datatype

boolean

Alias
UMLS CUI [1]
C0412675
5. Dementia as evidenced by impairment in two neuropsychological domains and a Mattis Dementia Score <130.
Beschrijving

5. Dementia as evidenced by impairment in two neuropsychological domains and a Mattis Dementia Score <130.

Datatype

boolean

Alias
UMLS CUI [1]
C0497327
6. A major untreated psychiatric disorder as revealed on psychiatric exam at screening, and a Beck Depression Inventory Score >14.
Beschrijving

6. A major untreated psychiatric disorder as revealed on psychiatric exam at screening, and a Beck Depression Inventory Score >14.

Datatype

boolean

Alias
UMLS CUI [1]
C0004936
7. Subjects with a history of seizures.
Beschrijving

7. Subjects with a history of seizures.

Datatype

boolean

Alias
UMLS CUI [1]
C0036572
8. Subjects who may require repeat MRI scans
Beschrijving

8. Subjects who may require repeat MRI scans

Datatype

boolean

Alias
UMLS CUI [1]
C0917711
UMLS CUI [2]
C0205341
9. Subjects with a history of a cranial neurosurgical procedure.
Beschrijving

9. Subjects with a history of a cranial neurosurgical procedure.

Datatype

boolean

Alias
UMLS CUI [1]
C0524850
UMLS CUI [2]
C3163632
10. Subjects with metal in the head or another implanted stimulator (e.g. vagus nerve stimulator, spinal cord stimulator, pacemaker, cochlear implant, etc).
Beschrijving

10. Subjects with metal in the head or another implanted stimulator (e.g. vagus nerve stimulator, spinal cord stimulator, pacemaker, cochlear implant, etc).

Datatype

boolean

Alias
UMLS CUI [1]
C0175727
UMLS CUI [2]
C0018670
11. Subjects who require treatment with Electroconvulsive therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS).
Beschrijving

11. Subjects who require treatment with Electroconvulsive therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS).

Datatype

boolean

Alias
UMLS CUI [1]
C0013806
12. Pregnant or nursing women or women who wish to become pregnant will be excluded.
Beschrijving

12. Pregnant or nursing women or women who wish to become pregnant will be excluded.

Datatype

boolean

Alias
UMLS CUI [1]
C0549206
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Similar models

Eligibility Parkinsons Disease NCT02318927

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Parkinson disease
Item
1. A clinical diagnosis of idiopathic PD, without a previous DBS operation
boolean
C0865475 (UMLS CUI [1])
Deep Brain Stimulation; Operative Surgical Procedures
Item
2. Must be deemed appropriate for a GPi DBS operation by the interdisciplinary screening team (GPi must be the target chosen as most appropriate for treatment of their PD to qualify for this study)
boolean
C0394162 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
age
Item
3. Age 30-75 years (must meet UK Brain Bank criteria for diagnosis of idiopathic Parkinson's disease).
boolean
C0001779 (UMLS CUI [1])
Gait
Item
4. Experiencing significant gait and postural instability despite optimal pharmacologic management (Hoehn and Yahr Stage II or greater in the on state).
boolean
C0016928 (UMLS CUI [1])
postural stability
Item
5. Best medication "on" does not reveal meaningful improvement in posture scores (Pull Test). Patients must be challenged in person with a suprathreshold dose of levodopa (1.5 times optimized regular dose of levodopa) and must have poor or no improvement in postural stability.
boolean
C3166208 (UMLS CUI [1])
Freezing of gait
Item
6. Patients must possess a clinical history of gait freezing > 2 episodes per month, to be included, participants must also score > 1 on item #3 of the Freezing of Gait (FOG) Questionnaire and exhibit five or more FoG episodes during the provocation protocol in on or off state.
boolean
C0860515 (UMLS CUI [1])
Levodopa;Responsive
Item
7. L-dopa responsive with clearly defined "on" periods.
boolean
C0023570 (UMLS CUI [1])
C0205342 (UMLS CUI [2])
Cooperation
Item
8. Willingness and ability to cooperate during conscious operative procedure, as well as during post-surgical evaluations, adjustments of medications and stimulator settings.
boolean
C0392337 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Significant; Disease
Item
1. Clinically significant medical disease that would increase the risk of developing pre- or postoperative complications. Clinically significant medical disease includes uncontrolled systemic hypertension with values above 170/100mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation which cannot be interrupted; any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician.
boolean
C0750502 (UMLS CUI [1])
C0012634 (UMLS CUI [2])
Secondary Parkinson Disease
Item
2. Evidence of secondary or atypical parkinsonism.
boolean
C0030569 (UMLS CUI [1])
musculoskeletal impairment; neurological impairments
Item
3. Other neurological and musculoskeletal impairments that would negatively influence postural stability
boolean
C0848778 (UMLS CUI [1])
C0521654 (UMLS CUI [2])
brain mri
Item
4. Past MRI scan with significant evidence of brain atrophy or other abnormalities.
boolean
C0412675 (UMLS CUI [1])
Dementia
Item
5. Dementia as evidenced by impairment in two neuropsychological domains and a Mattis Dementia Score <130.
boolean
C0497327 (UMLS CUI [1])
psychiatric disorder
Item
6. A major untreated psychiatric disorder as revealed on psychiatric exam at screening, and a Beck Depression Inventory Score >14.
boolean
C0004936 (UMLS CUI [1])
seizures
Item
7. Subjects with a history of seizures.
boolean
C0036572 (UMLS CUI [1])
MRI scans;Repeat
Item
8. Subjects who may require repeat MRI scans
boolean
C0917711 (UMLS CUI [1])
C0205341 (UMLS CUI [2])
Neurosurgical Procedures; Cranial
Item
9. Subjects with a history of a cranial neurosurgical procedure.
boolean
C0524850 (UMLS CUI [1])
C3163632 (UMLS CUI [2])
Stimulator; Head
Item
10. Subjects with metal in the head or another implanted stimulator (e.g. vagus nerve stimulator, spinal cord stimulator, pacemaker, cochlear implant, etc).
boolean
C0175727 (UMLS CUI [1])
C0018670 (UMLS CUI [2])
Electroconvulsive therapy
Item
11. Subjects who require treatment with Electroconvulsive therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS).
boolean
C0013806 (UMLS CUI [1])
Pregnant
Item
12. Pregnant or nursing women or women who wish to become pregnant will be excluded.
boolean
C0549206 (UMLS CUI [1])
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