The Relation Between the Prognosis of Subthalamic Nucleus Deep Brain Stimulation Surgery by Micro… (NCT06685510) | Clinical Trial Compass
By InvitationNot Applicable
The Relation Between the Prognosis of Subthalamic Nucleus Deep Brain Stimulation Surgery by Microlesion Effect and Electrode Position
China100 participantsStarted 2023-11-06
Plain-language summary
BACKGROUND: Parkinson's disease (PD) is a common movement disorder whose main symptoms include resting tremor, rigidity and bradykinesia. Deep Brain Stimulation (DBS) has become one of the most effective treatments for PD by implanting electrodes in specific deep brain nuclei to alleviate motor symptoms in PD patients. During the implantation of electrodes in the DBS procedure, small lesions produced are known as the Microlesion Effect, which disappears within a short period. The MLE efficacy is positively correlated with the overall efficacy of DBS, but whether the MLE efficacy is affected by the symptoms has not yet been investigated, and a large-sample study is needed to further validate this. This study aims to examine the relationship between electrode implantation location and the prediction of MLE efficacy produced by STN-DBS surgery in PD patients, assess the correlation between electrode implantation location and DBS efficacy in PD patients, and analyze the role of brain networks in the process. The study will also analyze the relationship between micro-destructive effects and long-term DBS efficacy, providing more effective efficacy prediction and a more accurate selection of electrode implantation locations for DBS treatment in PD patients. This study will guide the clinical practice of DBS treatment in PD patients and provide an important reference for future research in related fields.
Object: Primary Parkinson's Disease patients between the ages of 18 and 75 years who meet STN-DBS surgery criteria Aim: To observe the relationship between predicted efficacy and implantation location of STN-DBS for MLE in PD surgery
Who can participate
Age range
18 Years – 75 Years
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
. Idiopathic Parkinson Disease
. Age from 18 to 80 years old
. Performed bilateral STN-DBS
Exclusion criteria
. Does not meet STN-DBS surgical criteria
. Patients with severely offset electrode implantation position (imaging)
. Not fulfilling the criteria for an arbitrary cohort under exposure conditions;
. Patients who are unable to voluntarily sign an informed consent form;
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.
1This study is specifically for people who are already having deep brain stimulation surgery — does my current stage of Parkinson's disease and planned surgical approach make me a candidate worth discussing for this kind of research involvement?
2The trial seems to focus on something called a 'microlesion effect' — can you explain what that is, and how understanding it might change decisions about where my electrode gets placed during DBS surgery?
3Since this trial is listed as 'enrolling by invitation only,' who decides who gets invited to participate, and what would the process look like for someone under your care?
4This study is listed as Phase NA, which I understand often means it's more about observing and measuring than testing a new treatment — does joining this study change anything about how my DBS surgery would actually be performed, or is it mainly collecting information from a procedure I'd be having anyway?
5If this research finds a stronger connection between the microlesion effect and electrode position, how might that kind of finding eventually improve outcomes for Parkinson's patients like me down the road?
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.
What they're measuring
1
Comparing MLE and DBS efficacy
Timeframe: From baseline to 24 hours, 48 hours, 7 days ,6 months,one year after surgery
Trial details
NCT IDNCT06685510
SponsorSecond Affiliated Hospital of Nanchang University