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

NCT07637955 | Not Yet Recruiting

• 2 other identifiers: 38RC23.02232025-A00783-46
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

Parkinson's disease (PD); Subthalamic nucleus (STN); Sleep-wake disturbances

Outcome Measures

Primary Outcomes (2)

• Identification of specific electrophysiological markers of different sleep stages

  Electrophysiological signal records by nocturnal video-polysomnographies (vPSGs)

  1 year

• 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

  1 year

Secondary Outcomes (3)

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

  1 year

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

  1 year

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

  1 year

Study Arms (1)

Deep Brain Stimulation

EXPERIMENTAL

Procedure: Deep Brain Stimulation

Interventions

Deep Brain Stimulation PROCEDURE

Subthalamic nucleus stimulation

Deep Brain Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)
• Protected persons (Articles L1121-5 to L1121-8 of the French Public Health Code)

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Grenoble Institut des Neurosciences - GIN, U1216 Inserm UGA: collaborator

Study Sites (1)

Neurosurgery Department

Grenoble, Toutes, 38000, France

Location

Related Publications (4)

• Nambu A. Somatotopic organization of the primate Basal Ganglia. Front Neuroanat. 2011 Apr 20;5:26. doi: 10.3389/fnana.2011.00026. eCollection 2011.

  PMID: 21541304 BACKGROUND

• Baker KB, Montgomery EB Jr, Rezai AR, Burgess R, Luders HO. Subthalamic nucleus deep brain stimulus evoked potentials: physiological and therapeutic implications. Mov Disord. 2002 Sep;17(5):969-83. doi: 10.1002/mds.10206.

  PMID: 12360546 BACKGROUND

• Devergnas A, Wichmann T. Cortical potentials evoked by deep brain stimulation in the subthalamic area. Front Syst Neurosci. 2011 May 13;5:30. doi: 10.3389/fnsys.2011.00030. eCollection 2011.

  PMID: 21625611 BACKGROUND

• Davin A, Chabardes S, Devergnas A, Benstaali C, Gutekunst CN, David O, Torres-Martinez N, Piallat B. Excessive daytime sleepiness in a model of Parkinson's disease improved by low-frequency stimulation of the pedunculopontine nucleus. NPJ Parkinsons Dis. 2023 Jan 25;9(1):9. doi: 10.1038/s41531-023-00455-7.

  PMID: 36697421 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: June 10, 2026

Record last verified: 2026-05

Locations

FR (1)