Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT02288468
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients aged ≥ 35 and ≤ 75 years with a life expectancy of at least 5 years
2. Patients with Parkinson's disease according to the criteria of the British Brain Bank as diagnosed by an in movement disorder specialized neurologist
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.
4. Absence of postural instability (which would be aggravated under STN DBS)
5. Hoehn \& Yahr stage 1-3. After stadium 3 patients will show increased incidence of falling that can be aggravated by (typical) STN DBS
6. Disease duration for at least 2 years and routine DAT-scan shows clear indication for Parkinsonism and atypical Parkinson syndromes are ruled out by routine glucose (FDG) PET
7. PDQ-39 to be completed within 42 days prior surgery
8. Written informed consent
Exclusion Criteria:
1. Major Depression with suicidal thoughts
2. Dementia (Mattis Dementia Rating Score ≤ 130)
3. Patients with lifetime primary psychotic disorder, schizophrenia, or schizoaffective disorder
4. Patients with acute psychosis as diagnosed by a psychiatrist
5. Nursing care at home
6. Unable to give written informed consent
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
8. Patients with advanced stage cardiovascular disease
9. Patients under immunosuppressive or chemotherapy because of malignant disease
10. Patients who had previous intracranial surgery
11. Patients who are already under DBS therapy
12. Patients with aneurysm clips
13. Patients with cochlear implants
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)
15. Medications that are likely to cause interactions in the opinion of the investigator
16. Known or persistent abuse of medication, drugs or alcohol
17. Persons who are in a relationship of dependence/employment with the sponsor or the investigator
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;
19. Current or planned pregnancy, nursing period
20. Contraindications according to device instructions or Investigator's Brochure:
* 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.
* Magnetic Resonance Imaging (MRI): Patients implanted with the Vercise™ DBS System should not be subjected to MRI.
* Patient incapability: Patients who are unable to properly operate the Remote Control and Charging System should not be implanted with the Vercise™ DBS System.
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT02288468
Study Brief:
Protocol Section:
NCT02288468