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 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT02438033
Eligibility Criteria:
Inclusion Criteria:
1. Chart diagnosis of PD as the principal neurologic diagnosis with evidence of dopamine responsiveness.
2. Documented PD duration \> 5 years.
3. Clinical indications for GPi DBS based on presence of motor fluctuations with troublesome dyskinesias despite best medical therapy.
4. Age ≥ 21 years of age.
5. Able to give informed consent in accordance with institutional policies and participate in the 1-year follow-up, involving assessments and stimulator adjustments.
6. Willingness to have unexpected neurological or psychiatric symptoms shared with study clinicians.
7. Other medical conditions must be stable for at least 1 year, (conditions that require intermittent use of steroids or chemotherapy are excluded).
Exclusion Criteria:
1. Tremor-dominant PD.
2. Significant neurocognitive impairment in memory domain suggestive of dementing process (based on MOCA and PD-CRS, described below).
3. Age \> 75 years.
4. History of implant-related infection.
5. History of bleeding or immune-compromise.
6. Patient living greater than 100 miles from UCLA.
7. Suicide attempt in the last two years and/or presence of a suicide plan (an answer of "Yes" to Question C4 in Section C-Suicidality of MINI International Neuropsychiatric Interview).
8. Alcohol or illicit substance use disorder within the last 6 months, unstable remission of substance abuse, or chart evidence that co-morbid substance use disorder could account for lack of treatment response.
9. Current significant neurological conditions, including epilepsy, stroke, or history of serious head injury with loss of consciousness.
10. Uncontrolled medical condition including cardiovascular problems and diabetes.
11. Pregnant or planning to become pregnant
12. Uncontrolled chronic pain.
13. Preoperative use of warfarin or any blood thinning or antiplatelet agent or any patient with abnormally elevated preoperative coagulation profile (either PTT or PT/INR)..
14. Significant abnormality on preoperative structural brain MRI.
15. Contraindications to MRIs or the need for recurrent body MRIs.
16. High risk for surgery.
17. Has cardiac pacemaker/defibrillator, implanted medication pump, intra-cardiac lines, any intracranial implants (e.g., aneurysm clip, shunt, cochlear implant, electrodes) or other implanted stimulator.
18. Patient has had past cranial neurosurgery.
19. Patient unable to discontinue therapeutic diathermy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT02438033
Study Brief:
Protocol Section:
NCT02438033