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Sleep-specific Deep Brain Stimulation (DBS) Therapy in Parkinson's Disease

This study is looking at how Deep Brain Stimulation (DBS) affects sleep problems in people with Parkinson's disease. DBS is a treatment that uses electrical pulses to change brain activity and improve movement issues. Participants will already have or be planning to get a DBS device implanted as part of their regular care at the University of Minnesota. Researchers will compare how your regular DBS settings affect your sleep compared to when the stimulation is turned off. The main goal is to understand how DBS affects specific brain pathways (pallidopeduncular, pedunculopallidal, and GPe) at 6 and 12 months after DBS surgery. This will help us better understand the brain circuits involved in sleep disorders in Parkinson's disease. The study plans to enroll 64 participants, and its current status is unclear.

Study design
This is an interventional study planning to enroll 64 participants. It will compare regular clinical stimulation settings of Deep Brain Stimulation (DBS) versus no stimulation.
What's involved
You will have a Deep Brain Stimulation (DBS) system implanted as part of your standard medical care. The study will then examine the effects of your regular stimulation settings versus no stimulation.
Compensation
Not stated in the trial record.
Follow-up
The study will measure brain pathway activation at 6 months and 12 months after your DBS surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05962489

Sleep-specific DBS Therapy in Parkinson's Disease

Recruiting
NAAges 21+InterventionalBasic science
University of Minnesota
~64 participants
Updated 2026-03-03 on ClinicalTrials.gov
What's tested:Clinically optimized deep brain stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
pallidopeduncular and pedunculopallidal pathway activation
Measured over 6 months post DBS surgery
+7 more outcomes measured

Conditions

Deep Brain Stimulation
Parkinson's Disease and Parkinsonism
Dystonia

Explore related trials

DystoniaParkinson Disease

NCT05962489

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University Of Minnesota

    Minneapolis, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Emily Weatherill, BS
[email protected]
612-625-4947
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Diagnosis of idiopathic PD
At least 21 years old
Existing or planned 7T brain imaging
Surgery at UMN to implant DBS system in GPi or STN with directional lead(s) is planned as part of routine clinical care
Surgery at UMN to implant bilateral DBS system in GPi or STN with directional lead(s) is planned as part of routine clinical care (or has already occurred, as long as the initial programming session is at least 2 weeks away)

Exclusion

Other significant neurological disorder
History of dementia
Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
Pregnant women
Known radiation exposure within the last year that is determined to be unsafe when compounded with the expected radiation dose from intraoperative fluoroscopy to place ECoG strip

What this trial measures

  • pallidopeduncular and pedunculopallidal pathway activation6 months post DBS surgery

    Percent of pallidopeduncular and pedunculopallidal pathway activation

  • pallidopeduncular and pedunculopallidal pathway activation12 months post DBS surgery

    Percent of pallidopeduncular and pedunculopallidal pathway activation

  • GPe activation6 months post DBS surgery

    percent of GPe activation

  • GPe activation12 months post DBS surgery

    percent of GPe activation

  • Actigraphy6 months post DBS surgery

    Actigraphy-based measures of sleep quality

  • Actigraphy12 months post DBS surgery

    Actigraphy-based measures of sleep quality

  • Clinical Rating Scales6 months post DBS surgery

    Total scores from the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale

  • Clinical Rating Scales12 months post DBS surgery

    Total scores from the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale