Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07637955

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurosurgery Department

Grenoble, Toutes, 38000, France

Location contact

Stéphan CHABARDES, MD, PhD

CONTACT

[email protected]

33 (0)4 76 76 93 85

Stéphan CHABARDES, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

The subthalamic nucleus (STN) is a central structure of the basal ganglia circuit. Through its connection to the frontal cortex via the hyperdirect pathway, it is a key indicator of cortical activity, and its stimulation can exert an anterograde influence on the cortex. While the mechanisms of STN deep brain stimulation (DBS) are not yet fully understood, recent studies (see above) have demonstrated that Parkinson's disease (PD) patients with STN implants experience improved sleep. However, this improvement is insufficient to restore more physiological sleep, and further research is needed to develop better management strategies for sleep disorders. In this study, the investigators hypothesize that:

  • STN activity reflects cortical activity and can therefore detect events characteristic of sleep-wake disorders. 2) Such events detected on the basis of STN activity could allow for a better understanding of the role of the STN in sleep and the development of adaptive DBS targeting sleep disorders in addition to motor disorders.

This is a prospective, single-center, open-label pilot study. Patients with Parkinson's disease for whom surgery to implant deep brain stimulation electrodes in the subthalamic nucleus is indicated will be included. These patients will be recruited by the investigators during their follow-up visits to the neurosurgery department of Grenoble Alpes University Hospital.

In addition to providing a better understanding of how deep brain stimulation of the subthalamic nucleus impacts sleep/wake behavior, this study will allow for a more precise investigation of the subthalamic nucleus's involvement in the pathophysiology of sleep/wake behavior disorders in patients with Parkinson's disease. These results could then lead to the development of adaptive stimulation, triggered according to markers of sleep and wakefulness disorders.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Deep Brain Stimulation

Procedure

Subthalamic nucleus stimulation

Primary outcomes

  1. Identification of specific electrophysiological markers of different sleep stages

    Time frame: 1 year

    Electrophysiological signal records by nocturnal video-polysomnographies (vPSGs)

  2. Identification of sleep disorders based on the activity of the subthalamic nucleus

    Time frame: 1 year

    Local STN field potentials records via Medtronic Sensight electrodes of the Percept-Medtronic stimulator

Secondary outcomes

  1. Characterization of the sleep/wake behavioral disturbances (daytime and nighttime) of the patient with Parkinson's disease

    Time frame: 1 year

    Actigraphy measurements to monitor circadian rhythm

  2. Characterization of the sleep/wake behavioral disturbances (nighttime) of the patient with Parkinson's disease

    Time frame: 1 year

    Nocturnal video-polysomnography (vPSG) to assess sleep quality

  3. Characterization of the sleep/wake behavioral disturbances (daytime) of the patient with Parkinson's disease

    Time frame: 1 year

    Multiple sleep latency tests (MSLT) to assess daytime sleepiness

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Grenoble Institut des Neurosciences - GIN, U1216 Inserm UGA

Registry information

Acronym: SLEEP-STN

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.