Characterization of the Involvement of the Subthalamic Nucleus During Wakefulness and Sleep in Pa… (NCT07637955) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Characterization of the Involvement of the Subthalamic Nucleus During Wakefulness and Sleep in Parkinson's Disease: Contribution of Deep Brain Stimulation
France15 participantsStarted 2026-07
Plain-language summary
Sleep-wake disturbances are common in Parkinson's disease. These disturbances are associated with a decline in patients' quality of life and a poor prognosis. This clinical research project follows a study conducted in non-human primates that began in 2017 at the Grenoble Institute of Neuroscience. In this study, the investigators confirmed the existence of sleep-wake behavior disturbances in the macaque model of the disease, and the investigators characterized their nature and expression. These disturbances were founded to be very similar to those observed in patients with Parkinson's disease. The investigators then explored the involvement of different brain structures, potentially targets for deep brain stimulation, in sleep-wake behavior under healthy conditions and dopamine depletion (Parkinson's disease model). Among the deep brain stimulation targets being explored, the subthalamic nucleus (STN), still under investigation in this preclinical program, is a promising candidate for deep brain stimulation because this nucleus is strongly implicated in motor behavior and, more recently, in sleep/wake behavior. An ongoing study in non-human primates shows that it is possible to identify states of alertness based on STN activity, and an automatic detection algorithm is currently being evaluated.
Furthermore, this study will allow for the characterization of sleep/wake behavioral disturbances (diurnal and nocturnal) in patients with Parkinson's disease. Finally, this study will enable a correlation analysis between disease severity and sleep/wake disturbances.
Who can participate
Age range
18 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:
* Adult patients with Parkinson's disease, followed at Grenoble University Hospital, for whom surgery to implant deep brain stimulation electrodes in the subthalamic nucleus is indicated
* Patients agreeing to be implanted with a Medtronic PERCEPT stimulator (routine care)
* Patients who have given and signed informed consent
* Patients covered by social security or a similar scheme
Exclusion Criteria:
* Individuals who do not understand/speak French (prevents completion of questionnaires)
* Any condition that, in the investigator's opinion, will prevent the participant from successfully or safely completing the study procedures (i.e., dementia, severe depression, etc.)
* Subjects on exclusion from another study
* Protected persons (Articles L1121-5 to L1121-8 of the French Public Health Code)
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.
1Since this trial is not yet recruiting, how soon might it open, and would it make sense for me to stay on my current Parkinson's treatment plan in the meantime rather than waiting to enroll?
2This study is focused on recording brain activity from the subthalamic nucleus during sleep and wakefulness — does that mean it's primarily observational rather than testing a new treatment, and if so, what direct benefit, if any, might I personally get from participating?
3Because the trial involves deep brain stimulation, does participating require me to already have a DBS device implanted, and if I haven't had that surgery yet, would enrolling in this study influence whether or how soon you'd recommend it for me?
4The trial is measuring electrical signals in the brain during different sleep stages — what does that recording process actually involve day-to-day, and are there any risks or disruptions to my sleep or DBS settings that I should be aware of?
5Since one goal is identifying sleep disorders linked to subthalamic nucleus activity, could the findings from this study eventually change how my own sleep problems related to Parkinson's are diagnosed or managed, even if I don't end up participating?
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
Identification of specific electrophysiological markers of different sleep stages
Timeframe: 1 year
2
Identification of sleep disorders based on the activity of the subthalamic nucleus