Can Subthalamic Stimulation Using Directional Electrodes Improve Postoperative Management in Park… (NCT04578678) | Clinical Trial Compass
CompletedNot Applicable
Can Subthalamic Stimulation Using Directional Electrodes Improve Postoperative Management in Parkinson's Disease
France, Germany, Switzerland105 participantsStarted 2019-08-09
Plain-language summary
The primary objective of the study is to determine if subthalamic nucleus (STN) deep brain stimulation (DBS) using the Vercise directional leads improves neuropsychiatric state and neuropsychiatric fluctuations 12 months after surgery in a large consecutive series of STN-DBS Parkinson's disease (PD) patients.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
For all subjects:
* Informed consent as documented by signature
* Diagnosis of PD based on the MDS clinical diagnostic criteria for Parkinson's disease
* Fulfilling criteria for STN-DBS:
* The presence of disabling motor complications of dopaminergic treatment
* The absence of surgical contraindications
* Planned bilateral STN-DBS using steering electrodes in the next 3 months (routine standard of care)
Exclusion Criteria:
* Presence of dementia as indicated by a score ≤ 25 on the MOntreal Cognitive Assessment (MOCA)
* Depression with acute suicidal ideation
* Presence of major ongoing psychiatric illness
* Non-compensated systemic disease (i.e., diabetes, hypertension)
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Participation in interventional trial within the 30 days preceding and during the present study
* Previous enrolment into the current study
* Enrolment of any study site personnel, their family members, employees or other dependent persons
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.