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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT03446833
Eligibility Criteria:
Inclusion Criteria:
Preoperative:
1. Subject has the ability to understand and provide written informed consent for participation in the study prior to the study-related procedures being conducted
2. Subject with levodopa-responsive PD of at least 4 years' duration, with symptoms not adequately controlled with medication, including individuals with motor complications of recent onset (from 4 months to 3 years) or with motor complications of longer-standing duration, and who are eligible for bilateral STN DBS surgery
3. Subject is ≥ 22 years of age at time of informed consent
4. Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active, must be using, or agree to use, a medically-acceptable method of birth control as confirmed by the investigator
5. Subject has documented improvement in motor signs ON versus OFF dopaminergic medication, with a change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III score of \> 30% OFF to ON medication
6. Based on the opinion of the Neurosurgeon, the subject is an acceptable candidate for implant of a DBS System that includes: bilateral DBS leads targeted to the STN, extensions, and neurostimulator
7. Subject can read and understand English
8. Subject is willing and able to attend all study-required visits and complete the study procedures
9. Subject is willing and able to be awake during left and right DBS lead implant surgery and for intraoperative LFP recordings
Intraoperative:
10. Required beta band (13 - 30 Hz) signal detected on left and right DBS leads
Exclusion Criteria
1. Subject has tremor dominant PD ≥ 2 at rest in head, upper, or lower extremities as measured on the UPDRS Part III Question 20
2. Subject requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)
3. Subject has a history of prior intracranial surgery (eg, DBS, lesioning, previous surgical ablation)
4. Subject is unable to undergo Magnetic Resonance Imaging (MRI) of the head for planning the surgical DBS lead implants
5. Based on the opinion of the Neurosurgeon, the subject has a clinically significant structural abnormality(ies) of the brain that would jeopardize subject safety during the DBS lead implant, conduct of the study, or confound the subject's assessments
6. Subject has a metallic implant in the head, (eg, aneurysm clip, cochlear implant)
7. Subject has a major comorbidity increasing the risk of surgery (eg, prior stroke, severe diabetes, severe hypertension, immunocompromised, seizure disorder, active infection, need for chronic anticoagulation other than aspirin)
8. Subject has a neurocognitive impairment which exceeds the criteria for PD mild cognitive impairment (PD-MCI) as determined from the center's clinical neuropsychological evaluation prior to DBS for PD
9. Subject has, or plans to obtain, an implanted electrical stimulation medical device anywhere in the body (eg, cardiac pacemaker, defibrillator, spinal cord stimulator)
10. Subject has, or plans to obtain, an implanted medication pump (eg, DUOPATM infusion pump) and/or portable infusion pump
11. Based on the opinion of the investigator, the subject has an abnormal neurological examination that would preclude them from study participation
12. Subject is breast feeding
13. Subject has Mattis Dementia Rating Scale-2 (DRS-2) score ≤ 130
14. Subject has Beck Depression Inventory II (BDI-II) \> 25
15. Subject is currently participating, or plans to participate, in another investigational study unless written approval is provided by the Medtronic study team
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT03446833
Study Brief:
Protocol Section:
NCT03446833