Combined Deep Brain Stimulation in Parkinson's Disease (NCT05415774) | Clinical Trial Compass
CompletedNot Applicable
Combined Deep Brain Stimulation in Parkinson's Disease
France10 participantsStarted 2022-09-09
Plain-language summary
The study is a pilot study on Parkinson's disease patients to evaluate Combined deep brain stimulation of the substantia nigra pars reticulata and of the subthalamic nucleus for unresponsive freezing of gait.
Who can participate
Age range
18 Years – 100 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 PD defined as by the MDS Criteria ;
. Patients submitted to STN-DBS, for at least 6 months;
. Patients with STN-DBS at 130Hz;
. Patients with a troublesome FoG according to the "NFOG-Q", Part II Item II ≥ 2 or Part III Item 7 ≥ 2;
. Mini Mental State (MMS) ≥ 25 ;
. Ventral contact of electrodes implanted in the SNr (according to analysis of activated tissue volume models (VTA));
. Patients with stable parkinsonian stimulation parameters and anti-parkinsonian treatments for one month before the inclusion visit;
. Patients with H/Y stage ≤ 3 in the Med ON/Stim On condition (at 130Hz, S-stimulation);
Exclusion criteria
. Patient with atypical Parkinsonian syndrome;
. Patient with severe FoG before DBS, i.e. MDS-UPDRS item 2.13 in Med ON ≥2 or MDS-UPDRS item 3.11 ≥2 in Med On;
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.
What they're measuring
1
Score change of the " New freezing of gait questionnaire "