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.
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
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)
Single group
Deep Brain Stimulation
Procedure/SurgerySubthalamic nucleus stimulation
Identification of specific electrophysiological markers of different sleep stages
Electrophysiological signal records by nocturnal video-polysomnographies (vPSGs)
Identification of sleep disorders based on the activity of the subthalamic nucleus
Local STN field potentials records via Medtronic Sensight electrodes of the Percept-Medtronic stimulator
Characterization of the sleep/wake behavioral disturbances (daytime and nighttime) of the patient with Parkinson's disease
Actigraphy measurements to monitor circadian rhythm
Characterization of the sleep/wake behavioral disturbances (nighttime) of the patient with Parkinson's disease
Nocturnal video-polysomnography (vPSG) to assess sleep quality
Characterization of the sleep/wake behavioral disturbances (daytime) of the patient with Parkinson's disease
Multiple sleep latency tests (MSLT) to assess daytime sleepiness
Click on the lead sponsor to view all of their trials.
University Hospital, Grenoble
Lead sponsor
Grenoble Institut des Neurosciences - GIN, U1216 Inserm UGA
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
