Brain stimulation that adapts to sleep stages could restore rest in Parkinson's
NCT ID NCT04620551
The trial has finished. Results may not be published yet.
First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This study tests whether a smart deep brain stimulation (DBS) device can improve sleep in people with Parkinson's disease. The device records brain signals to identify sleep stages and then delivers stimulation only during certain phases to promote deeper, restorative sleep. Researchers will compare sleep patterns with and without this adaptive stimulation in 20 Parkinson's patients who already have DBS implants. The goal is to see if this approach can ease sleep problems that often accompany Parkinson's.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- Adaptive deep brain stimulation (DBS) using the Medtronic RC+S Summit System
- What this could lead to
- If successful, this could lead to a new way to improve sleep quality in Parkinson's patients using personalized brain stimulation, potentially reducing reliance on sedative drugs.
- What could go wrong
- This is a small early-stage study (20 participants) focused on feasibility and biomarkers, so results may not apply broadly. Risks include surgical complications from DBS and the possibility that adaptive stimulation may not consistently improve sleep.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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20 people
The number who actually took part.
- Started
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Oct 2020
- Finished
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Jun 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Ability to provide informed consent for this study * Diagnosis of Idiopathic Parkinson's disease with motor symptoms that have been present for a minimum of 4 years * Motor symptoms are severe enough, despite optimized medical therapy, to warrant surgical implantation of DBS * UPDRS-III score off medication between 20 and 80, and an improvement in UPDRS-III score on medications of at least 30%, or patients with tremor-dominant PD (score \>/= 2 on UPDRS-III tremor sub-score)-or tremor in addition to other motor symptoms-that is treatment-resistant and results in significant functional disability * Appropriate trials of oral PD medications have resulted in inadequate relief of motor symptoms * Absence of abnormalities on brain MRI suggestive of an alternate diagnosis or serving as a contraindication to surgery * Absence of significant cognitive deficits or significant depression (BDI-II score \> 20) on formal Neuropsychological Testing * Age 21 - 80 years Exclusion Criteria: * Coagulopathy, uncontrolled hypertension, history of seizures, heart disease, inability to undergo general anesthesia * Pregnancy * Significant untreated depression (BDI-II score \> 20) * Personality or mood disorder symptoms that Study Personnel believe will interfere with study requirements * Patients requiring ongoing treatment with ECT, rTMS, or diathermy * Pre-existing implanted stimulation system (e.g., cochlear implant, cardiac pacemaker, defibrillator, neuro-stimulator for indication other than Parkinson's disease) or ferromagnetic metallic implant * Prior intracranial surgery * History of, or active, drug or alcohol abuse * Meets criteria for PD with Mild Cognitive Impairment (PD-MCI), as defined by Performance \> 2 standard deviations below appropriate norms on tests from 2 or more of the following cognitive domains: Attention, Executive Function, Language, Memory, and Visuospatial Ability * Patients with Restless Leg Syndrome
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
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