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Parkinson DiseaseSLEEP-STNNCT07637955

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

A study testing Deep Brain Stimulation in people with Parkinson Disease, run by University Hospital, Grenoble at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
Deep Brain Stimulation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteFrance
Study dates
Jul 2026to Jul 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site

  • Neurosurgery Department

    Grenoble, Toutes, 38000

    Stéphan CHABARDES, MD, PhD, 33 (0)4 76 76 93 85, SChabardes@chu-grenoble.fr

    Stéphan CHABARDES, MD, PhD

Other trials in France

About this study

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.

Read the detailed description

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:

  1. 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.

Being tested
Deep Brain Stimulation
Keywords
Parkinson's disease (PD), Subthalamic nucleus (STN), Sleep-wake disturbances
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Deep Brain StimulationProcedure or surgery

    Subthalamic nucleus stimulation

Study groups in NCT07637955
Study groupRoleWhat they receive
Deep Brain StimulationExperimentalNot described
Receives: Procedure: Deep Brain Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identification of specific electrophysiological markers of different sleep stages

    Electrophysiological signal records by nocturnal video-polysomnographies (vPSGs)

    Measured: 1 year

  2. 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

    Measured: 1 year

Secondary outcomes (3)

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

    Actigraphy measurements to monitor circadian rhythm

    Measured: 1 year

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

    Nocturnal video-polysomnography (vPSG) to assess sleep quality

    Measured: 1 year

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

    Multiple sleep latency tests (MSLT) to assess daytime sleepiness

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07637955
Sponsor's protocol ID
38RC23.0223
Other IDs
2025-A00783-46
Acronym
SLEEP-STN
Status last verified
May 2026
First submitted
29 May 2026
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

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

    PubMed 21541304

  • 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.

    PubMed 12360546

  • 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.

    PubMed 21625611

  • 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.

    PubMed 36697421

Questions about this trial

What is this clinical trial studying?

A study testing Deep Brain Stimulation in people with Parkinson Disease, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identification of specific electrophysiological markers of different sleep stages (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07637955, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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