ID

23055

Beschreibung

One Pass thalamIc aNd subthalamIc stimulatiON; ODM derived from: https://clinicaltrials.gov/show/NCT02288468

Link

https://clinicaltrials.gov/show/NCT02288468

Stichworte

Versionen (2)
  1. 13.06.16 13.06.16 -
  2. 21.06.17 21.06.17 - Martin Dugas
Hochgeladen am

21. Juni 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Deep Brain Stimulation Parkinson's Disease DRKS00007526 NCT02288468 DRKS00007526

Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female patients aged ≥ 35 and ≤ 75 years with a life expectancy of at least 5 years
Beschreibung

Age | Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0023671
2. patients with parkinson's disease according to the criteria of the british brain bank as diagnosed by an in movement disorder specialized neurologist
Beschreibung

Parkinson Disease | Movement Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2]
C0026650
3. parkinson patients are included with a medical treatment resistant and disabling resting and/or postural tremor as their major complaint and with a less prominent or absent hypokinetic-rigid component of their disease.
Beschreibung

Parkinson Disease | Therapeutic procedure Resistant | Disabling condition | Static Tremor | Parkinsonian Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0332325
UMLS CUI [3]
C4061999
UMLS CUI [4]
C0234378
UMLS CUI [5]
C0242422
4. absence of postural instability (which would be aggravated under stn dbs)
Beschreibung

Postural instability Absent | Subthalamic nucleus Deep Brain Stimulation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1843921
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1281060
UMLS CUI [2,2]
C0394162
5. hoehn & yahr stage 1-3. after stadium 3 patients will show increased incidence of falling that can be aggravated by (typical) stn dbs
Beschreibung

Hoehn and Yahr grades | Falls Increasing incidence | Subthalamic nucleus Deep Brain Stimulation

Datentyp

boolean

Alias
UMLS CUI [1]
C0451215
UMLS CUI [2,1]
C0085639
UMLS CUI [2,2]
C0220888
UMLS CUI [3,1]
C1281060
UMLS CUI [3,2]
C0394162
6. disease duration > 4 years
Beschreibung

disease length

Datentyp

boolean

Alias
UMLS CUI [1]
C0872146
7. pdq-39 to be completed within 42 days prior surgery
Beschreibung

Parkinson's Disease Rating Scale Questionnaire Completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3639721
UMLS CUI [1,2]
C0205197
8. written informed consent
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. major depression with suicidal thoughts
Beschreibung

Major Depressive Disorder | Feeling suicidal

Datentyp

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0424000
2. dementia (mattis dementia rating score ≤ 130)
Beschreibung

Dementia

Datentyp

boolean

Alias
UMLS CUI [1]
C0497327
3. patients with lifetime primary psychotic disorder, schizophrenia, or schizoaffective disorder
Beschreibung

Psychotic Disorders Primary Lifetime | Schizophrenia | Schizoaffective Disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033975
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C4071830
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0036337
4. patients with acute psychosis as diagnosed by a psychiatrist
Beschreibung

Acute psychosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0281774
5. nursing care at home
Beschreibung

nursing home care

Datentyp

boolean

Alias
UMLS CUI [1]
C0260062
6. unable to give written informed consent
Beschreibung

Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
7. surgical contraindications like deformed or displaced or not discernable target region, scarring after brain disease (infarction), need for continuous anticoagulation that cannot be bridged in order to obtain normal coagulation
Beschreibung

Surgical contraindication | Target region deformed | Target region Displaced | Cicatrization Post Brain Diseases | Infarction | Anticoagulation Therapy Continuous Needed

Datentyp

boolean

Alias
UMLS CUI [1]
C1301638
UMLS CUI [2,1]
C1521840
UMLS CUI [2,2]
C0205147
UMLS CUI [2,3]
C0333067
UMLS CUI [3,1]
C1521840
UMLS CUI [3,2]
C0205147
UMLS CUI [3,3]
C0012727
UMLS CUI [4,1]
C0008767
UMLS CUI [4,2]
C0687676
UMLS CUI [4,3]
C0006111
UMLS CUI [5]
C0021308
UMLS CUI [6,1]
C0003281
UMLS CUI [6,2]
C0549178
UMLS CUI [6,3]
C0027552
8. patients with advanced stage cardiovascular disease
Beschreibung

Cardiovascular Disease Advanced

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205179
9. patients under immunosuppressive or chemotherapy because of malignant disease
Beschreibung

Malignant Neoplasms | Therapeutic immunosuppression | Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0021079
UMLS CUI [3]
C0392920
10. patients who had previous intracranial surgery
Beschreibung

intracranial surgery Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0745377
UMLS CUI [1,2]
C0205156
11. patients who are already under dbs therapy
Beschreibung

Deep Brain Stimulation Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0394162
UMLS CUI [1,2]
C0087111
12. patients with aneurysm clips
Beschreibung

Aneurysm clip

Datentyp

boolean

Alias
UMLS CUI [1]
C0179977
13. patients with cochlear implants
Beschreibung

Cochlear Implants

Datentyp

boolean

Alias
UMLS CUI [1]
C0009199
14. simultaneous participation or previous participation within 30 days prior to start of screening in a clinical trial involving investigational medicinal product(s) or investigational medical device(s)
Beschreibung

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
15. medications that are likely to cause interactions in the opinion of the investigator
Beschreibung

Pharmaceutical Preparations Causing Drug Interactions

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0687133
16. known or persistent abuse of medication, drugs or alcohol
Beschreibung

Medication abuse | Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0260268
UMLS CUI [2]
C0038586
17. persons who are in a relationship of dependence/employment with the sponsor or the investigator
Beschreibung

Relationships Employment Research Personnel

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C0014003
UMLS CUI [1,3]
C0035173
18. fertile women not using adequate contraceptive methods: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception;
Beschreibung

Gender | Fertility | CONTRACEPTION NOT USED | Female Condoms | Vaginal contraceptive diaphragm | Contraceptive coil | Vaginal Spermicides | Intrauterine Devices | Hormonal contraception | Mechanical Methods Contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0015895
UMLS CUI [3]
C0742784
UMLS CUI [4]
C0221829
UMLS CUI [5]
C0042241
UMLS CUI [6]
C0419518
UMLS CUI [7]
C0087145
UMLS CUI [8]
C0021900
UMLS CUI [9]
C2985296
UMLS CUI [10,1]
C0443254
UMLS CUI [10,2]
C0700589
19. current or planned pregnancy, nursing period
Beschreibung

Pregnancy | Pregnancy, Planned | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
20. contraindications according to device instructions or investigator's brochure:
Beschreibung

Medical contraindication Due to Medical Device Instructions | Medical contraindication Due to Clinical Trial Investigator Brochure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0025080
UMLS CUI [1,4]
C1442085
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C3890035
diathermy: shortwave, microwave, and/or therapeutic ultrasound diathermy. the energy generated by diathermy can be transferred to the vercise™ dbs system, causing tissue damage at the contact site resulting in severe patient injury or death.
Beschreibung

Diathermy | Short-Wave Therapy | Microwave Therapy | Ultrasound Therapy Systems, Physical Therapy | Deep Brain Stimulation | Tissue damage | Injury | Event Consequence - Death

Datentyp

boolean

Alias
UMLS CUI [1]
C0012002
UMLS CUI [2]
C0037000
UMLS CUI [3]
C0438673
UMLS CUI [4]
C0184203
UMLS CUI [5]
C0394162
UMLS CUI [6]
C0010957
UMLS CUI [7]
C3263722
UMLS CUI [8]
C1546949
magnetic resonance imaging (mri): patients implanted with the vercise™ dbs system should not be subjected to mri.
Beschreibung

Magnetic Resonance Imaging | Deep Brain Stimulation

Datentyp

boolean

Alias
UMLS CUI [1]
C0024485
UMLS CUI [2]
C0394162
patient incapability: patients who are unable to properly operate the remote control and charging system should not be implanted with the vercise™ dbs system.
Beschreibung

Assistive remote control system | Deep Brain Stimulation

Datentyp

boolean

Alias
UMLS CUI [1]
C3877918
UMLS CUI [2]
C0394162
poor surgical risks: the vercise™ dbs system is not recommended for patients who- because of their primary disease or additional co-morbidities - are not likely to benefit from the dbs system implantation.
Beschreibung

Deep Brain Stimulation | Operative Surgical Procedure High risk | Primary disorders | Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0394162
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0332167
UMLS CUI [3]
C0277554
UMLS CUI [4]
C0009488
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Life Expectancy
Item
1. male or female patients aged ≥ 35 and ≤ 75 years with a life expectancy of at least 5 years
boolean
C0001779 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Parkinson Disease | Movement Disorders
Item
2. patients with parkinson's disease according to the criteria of the british brain bank as diagnosed by an in movement disorder specialized neurologist
boolean
C0030567 (UMLS CUI [1])
C0026650 (UMLS CUI [2])
Parkinson Disease | Therapeutic procedure Resistant | Disabling condition | Static Tremor | Parkinsonian Disorders
Item
3. parkinson patients are included with a medical treatment resistant and disabling resting and/or postural tremor as their major complaint and with a less prominent or absent hypokinetic-rigid component of their disease.
boolean
C0030567 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0332325 (UMLS CUI [2,2])
C4061999 (UMLS CUI [3])
C0234378 (UMLS CUI [4])
C0242422 (UMLS CUI [5])
Postural instability Absent | Subthalamic nucleus Deep Brain Stimulation
Item
4. absence of postural instability (which would be aggravated under stn dbs)
boolean
C1843921 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1281060 (UMLS CUI [2,1])
C0394162 (UMLS CUI [2,2])
Hoehn and Yahr grades | Falls Increasing incidence | Subthalamic nucleus Deep Brain Stimulation
Item
5. hoehn & yahr stage 1-3. after stadium 3 patients will show increased incidence of falling that can be aggravated by (typical) stn dbs
boolean
C0451215 (UMLS CUI [1])
C0085639 (UMLS CUI [2,1])
C0220888 (UMLS CUI [2,2])
C1281060 (UMLS CUI [3,1])
C0394162 (UMLS CUI [3,2])
disease length
Item
6. disease duration > 4 years
boolean
C0872146 (UMLS CUI [1])
Parkinson's Disease Rating Scale Questionnaire Completed
Item
7. pdq-39 to be completed within 42 days prior surgery
boolean
C3639721 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Informed consent
Item
8. written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Major Depressive Disorder | Feeling suicidal
Item
1. major depression with suicidal thoughts
boolean
C1269683 (UMLS CUI [1])
C0424000 (UMLS CUI [2])
Dementia
Item
2. dementia (mattis dementia rating score ≤ 130)
boolean
C0497327 (UMLS CUI [1])
Psychotic Disorders Primary Lifetime | Schizophrenia | Schizoaffective Disorder
Item
3. patients with lifetime primary psychotic disorder, schizophrenia, or schizoaffective disorder
boolean
C0033975 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C4071830 (UMLS CUI [1,3])
C0036341 (UMLS CUI [2])
C0036337 (UMLS CUI [3])
Acute psychosis
Item
4. patients with acute psychosis as diagnosed by a psychiatrist
boolean
C0281774 (UMLS CUI [1])
nursing home care
Item
5. nursing care at home
boolean
C0260062 (UMLS CUI [1])
Informed Consent Unable
Item
6. unable to give written informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Surgical contraindication | Target region deformed | Target region Displaced | Cicatrization Post Brain Diseases | Infarction | Anticoagulation Therapy Continuous Needed
Item
7. surgical contraindications like deformed or displaced or not discernable target region, scarring after brain disease (infarction), need for continuous anticoagulation that cannot be bridged in order to obtain normal coagulation
boolean
C1301638 (UMLS CUI [1])
C1521840 (UMLS CUI [2,1])
C0205147 (UMLS CUI [2,2])
C0333067 (UMLS CUI [2,3])
C1521840 (UMLS CUI [3,1])
C0205147 (UMLS CUI [3,2])
C0012727 (UMLS CUI [3,3])
C0008767 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C0006111 (UMLS CUI [4,3])
C0021308 (UMLS CUI [5])
C0003281 (UMLS CUI [6,1])
C0549178 (UMLS CUI [6,2])
C0027552 (UMLS CUI [6,3])
Cardiovascular Disease Advanced
Item
8. patients with advanced stage cardiovascular disease
boolean
C0007222 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Malignant Neoplasms | Therapeutic immunosuppression | Chemotherapy
Item
9. patients under immunosuppressive or chemotherapy because of malignant disease
boolean
C0006826 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
intracranial surgery Previous
Item
10. patients who had previous intracranial surgery
boolean
C0745377 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Deep Brain Stimulation Therapeutic procedure
Item
11. patients who are already under dbs therapy
boolean
C0394162 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Aneurysm clip
Item
12. patients with aneurysm clips
boolean
C0179977 (UMLS CUI [1])
Cochlear Implants
Item
13. patients with cochlear implants
boolean
C0009199 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
14. simultaneous participation or previous participation within 30 days prior to start of screening in a clinical trial involving investigational medicinal product(s) or investigational medical device(s)
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Pharmaceutical Preparations Causing Drug Interactions
Item
15. medications that are likely to cause interactions in the opinion of the investigator
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0687133 (UMLS CUI [1,3])
Medication abuse | Substance Use Disorders
Item
16. known or persistent abuse of medication, drugs or alcohol
boolean
C0260268 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
Relationships Employment Research Personnel
Item
17. persons who are in a relationship of dependence/employment with the sponsor or the investigator
boolean
C0439849 (UMLS CUI [1,1])
C0014003 (UMLS CUI [1,2])
C0035173 (UMLS CUI [1,3])
Gender | Fertility | CONTRACEPTION NOT USED | Female Condoms | Vaginal contraceptive diaphragm | Contraceptive coil | Vaginal Spermicides | Intrauterine Devices | Hormonal contraception | Mechanical Methods Contraception
Item
18. fertile women not using adequate contraceptive methods: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception;
boolean
C0079399 (UMLS CUI [1])
C0015895 (UMLS CUI [2])
C0742784 (UMLS CUI [3])
C0221829 (UMLS CUI [4])
C0042241 (UMLS CUI [5])
C0419518 (UMLS CUI [6])
C0087145 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
C2985296 (UMLS CUI [9])
C0443254 (UMLS CUI [10,1])
C0700589 (UMLS CUI [10,2])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
19. current or planned pregnancy, nursing period
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Medical contraindication Due to Medical Device Instructions | Medical contraindication Due to Clinical Trial Investigator Brochure
Item
20. contraindications according to device instructions or investigator's brochure:
boolean
C1301624 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0025080 (UMLS CUI [1,3])
C1442085 (UMLS CUI [1,4])
C1301624 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C3890035 (UMLS CUI [2,3])
Diathermy | Short-Wave Therapy | Microwave Therapy | Ultrasound Therapy Systems, Physical Therapy | Deep Brain Stimulation | Tissue damage | Injury | Event Consequence - Death
Item
diathermy: shortwave, microwave, and/or therapeutic ultrasound diathermy. the energy generated by diathermy can be transferred to the vercise™ dbs system, causing tissue damage at the contact site resulting in severe patient injury or death.
boolean
C0012002 (UMLS CUI [1])
C0037000 (UMLS CUI [2])
C0438673 (UMLS CUI [3])
C0184203 (UMLS CUI [4])
C0394162 (UMLS CUI [5])
C0010957 (UMLS CUI [6])
C3263722 (UMLS CUI [7])
C1546949 (UMLS CUI [8])
Magnetic Resonance Imaging | Deep Brain Stimulation
Item
magnetic resonance imaging (mri): patients implanted with the vercise™ dbs system should not be subjected to mri.
boolean
C0024485 (UMLS CUI [1])
C0394162 (UMLS CUI [2])
Assistive remote control system | Deep Brain Stimulation
Item
patient incapability: patients who are unable to properly operate the remote control and charging system should not be implanted with the vercise™ dbs system.
boolean
C3877918 (UMLS CUI [1])
C0394162 (UMLS CUI [2])
Deep Brain Stimulation | Operative Surgical Procedure High risk | Primary disorders | Comorbidity
Item
poor surgical risks: the vercise™ dbs system is not recommended for patients who- because of their primary disease or additional co-morbidities - are not likely to benefit from the dbs system implantation.
boolean
C0394162 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
C0277554 (UMLS CUI [3])
C0009488 (UMLS CUI [4])
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