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])
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])