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Clinical Trials in France / NCT07637955
Starting soon Not applicable

Characterization of the Involvement of the Subthalamic Nucleus During Wakefulness and Sleep in Parkinson's Disease: Contribution of Deep Brain Stimulation

NCT07637955 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Grenoble
Phase
Not applicable
Started
2026-07
Last updated
2026-06-10

Condition(s) studied

Parkinson Disease

Investigational drug(s) / intervention(s)

Deep Brain Stimulation

Deep Brain Stimulation: Subthalamic nucleus stimulation

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Identification of specific electrophysiological markers of different sleep stages — 1 year
    Electrophysiological signal records by nocturnal video-polysomnographies (vPSGs)
  • Identification of sleep disorders based on the activity of the subthalamic nucleus — 1 year
    Local STN field potentials records via Medtronic Sensight electrodes of the Percept-Medtronic stimulator

Trial sites (1)

FacilityCityRegionStatus
Neurosurgery Department Grenoble Toutes

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07637955 on ClinicalTrials.gov ↗ ← All trials in France