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:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT03079960
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients aged ≥ 35 and ≤ 75 years
2. Patients with diagnosed PD according to UK PDS Brain Bank Criteria.
3. Written informed consent.
4. For PG-O and PG-pre, patients who are eligible for STN DBS Surgery according to the guidelines of the DGN (www.dgn.org)
5. For PG-chronic, patients who have received permanent DBS implantation in the past and who use the DBS treatment.
Exclusion Criteria:
1. MR Imaging shows a contraindication for microelectrode recordings. If imaging shows a high amount of blood vessels in the target region and no safe trajectory for inserting the microelectrode can be found, then the patient may receive implantation of the macroelectrode without preceding microelectrode measurements, but is excluded from the study.
2. Contraindication for stereotactical neurosurgery.
3. Dementia (Mattis Dementia Rating Score ≤ 130)
4. Acute psychosis stated by a psychiatric physician
5. Unable to give written informed consent
6. Surgical contraindications
7. Medications that are likely to cause interactions in the opinion of the investigator
8. 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;
9. Current or planned pregnancy, nursing period
10. Contraindications according to device instructions or Investigator's Brochure:
1. Diathermy (shortwave, microwave, and/or therapeutic ultrasound diathermy)
2. Magnetic Resonance Imaging (MRI)
3. Patient incapability
11. Patients to be expected poor surgical candidates
For PG-chronic, only exclusion criteria 3, 4, 5, 7, 8, 9, 10 are applicable, since electrodes are already implanted, thus, no surgical procedure is necessary.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT03079960
Study Brief:
Protocol Section:
NCT03079960