Neurostimulation for Sleep Problems in Parkinson's Disease
Recruiting in Palo Alto (17 mi)
+3 other locations
Overseen byAviva Abosch, MD, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Nebraska
Must not be taking: Anticoagulants
Disqualifiers: Seizures, Heart disease, Alcohol abuse, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This study is aimed at testing the hypothesis that adaptive stimulation of the Subthalamic Nucleus (STN) drives changes in sleep episode maintenance and improves sleep quality. Investigators will directly test the efficacy of an adaptive stimulation protocol. Study subjects are adults with Parkinson's disease who experience inadequate motor symptom relief, and who have been offered implantation of a deep brain stimulator system targeting STN for the treatment of motor symptoms (standard-of-care). Investigators will implant 20 (n = 10 per clinical site) Parkinson's Disease subjects with the Medtronic RC+S System, enabling the implementation of real-time adaptive stimulation during in-home sleep. Prior to surgery, study subjects will complete clinical sleep questionnaires in an outpatient setting and wear an actigraphy watch for 3 weeks to monitor sleep architecture and sleep fragmentation. Three months after subjects have completed their standard-of-care Deep Brain Stimulation surgery and are optimized in terms of Parkinson's medication and clinical DBS stimulation parameters, we will monitor sleep for an additional 3 weeks, using in-home monitoring. During each week of the in-home monitoring period, subjects will undergo, in a randomized and double-blind fashion, one of three nocturnal stimulation algorithms: Adaptive stimulation, Open-Loop stimulation (standard clinical stimulation therapy) and No stimulation (control). During the 3 weeks of in-home sleep monitoring, we will monitor sleep architecture and sleep fragmentation using an actigraphy watch and subjects will complete a sleep questionnaire. At the end of the 3-week period of sleep-time randomized, blinded stimulation delivery, subjects will return to their standard stimulation therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that anti-Parkinson's medications should be at stable doses for 30 days before joining the study.
What data supports the effectiveness of the treatment Deep Brain Stimulation for sleep problems in Parkinson's Disease?
Research shows that Deep Brain Stimulation (DBS) in Parkinson's patients significantly improves overall sleep quality and motor symptoms, although it doesn't change issues like nighttime urination or daytime sleepiness.
12345Is deep brain stimulation safe for humans?
Deep brain stimulation (DBS) has been used in humans, particularly for Parkinson's disease, and is generally considered safe, though specific safety outcomes are not detailed in the provided research articles.
13567How is the treatment Deep Brain Stimulation (DBS) unique for sleep problems in Parkinson's disease?
Deep Brain Stimulation (DBS) is unique because it involves implanting electrodes in the brain to improve motor function and potentially enhance sleep quality in Parkinson's disease patients, unlike traditional medications that primarily focus on dopamine replacement.
12356Eligibility Criteria
Adults aged 18-80 with Parkinson's disease and motor symptoms for at least 4 years, who are approved for Subthalamic Nucleus (STN) Deep Brain Stimulation surgery. Participants must not have significant cognitive deficits or untreated depression, no history of drug/alcohol abuse, and cannot be pregnant.Inclusion Criteria
I have been diagnosed with Parkinson's disease and have had motor symptoms for at least 4 years.
My movement symptoms are severe and need surgery despite medication.
My brain MRI does not show any issues that would prevent surgery.
+8 more
Exclusion Criteria
I have been diagnosed with Obstructive Sleep Apnea.
I have Parkinson's with mild cognitive issues in at least two areas like memory or attention.
I do not have any health conditions that would make surgery too risky.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
3 weeks
1 visit (in-person), actigraphy monitoring
Pre-Surgery Monitoring
Participants complete clinical sleep questionnaires and wear an actigraphy watch to monitor sleep architecture and fragmentation
3 weeks
Post-Surgery Optimization
Participants undergo standard-of-care Deep Brain Stimulation surgery and optimization of Parkinson's medication and DBS parameters
3 months
Treatment
Participants undergo randomized, double-blind nocturnal stimulation with adaptive, open-loop, and no stimulation conditions
3 weeks
In-home monitoring
Follow-up
Participants are monitored for changes in sleep quality and efficiency using actigraphy and sleep questionnaires
4 weeks
Participant Groups
The trial is testing an adaptive stimulation protocol using the Medtronic RC+S System during sleep to improve sleep quality in Parkinson's patients. It compares three nocturnal stimulations: Adaptive, Open-Loop (standard therapy), and No stimulation over a period of three weeks.
3Treatment groups
Experimental Treatment
Active Control
Group I: Adaptive DBS stimulationExperimental Treatment1 Intervention
Subjects experience adaptive stimulation during one week of at-home night sleep.
Group II: Open-loop DBS stimulationActive Control1 Intervention
Subjects experience open-loop stimulation (standard clinical stimulation therapy based on DBS programming for the treatment of motor symptoms) during one week of at-home night sleep.
Group III: No DBS StimulationActive Control1 Intervention
DBS stimulation is turned off (control) during one week of at-home night sleep.
Deep Brain Stimulation is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Deep Brain Stimulation for:
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
- Stroke-related motor deficits (under investigation)
🇪🇺 Approved in European Union as Deep Brain Stimulation for:
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
🇨🇦 Approved in Canada as Deep Brain Stimulation for:
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Pennsylvania Health SystemPhiladelphia, PA
University of Nebraska Medical CenterOmaha, NE
Standord University Medical CenterStanford, CA
University of Colorado Denver School of MedicineAurora, CO
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Who Is Running the Clinical Trial?
University of NebraskaLead Sponsor
References
Sleep symptoms and polysomnographic architecture in advanced Parkinson's disease after chronic bilateral subthalamic stimulation. [2022]To evaluate the sleep symptoms and polysomnographic architecture in advanced Parkinson's disease after chronic bilateral subthalamic stimulation (STN-DBS).
Adaptive Deep Brain Stimulation for sleep stage targeting in Parkinson's disease. [2023]Sleep dysfunction is disabling in people with Parkinson's disease and is linked to worse motor and non-motor outcomes. Sleep-specific adaptive Deep Brain Stimulation has the potential to target pathophysiologies of sleep.
Changes in Parkinson's disease sleep symptoms and daytime somnolence after bilateral subthalamic deep brain stimulation in Parkinson's disease. [2020]Deep brain stimulation (DBS) markedly improves motor function in advanced Parkinson's disease (PD), but its effect on sleep is less clear.
A quantitative analysis of the effect of bilateral subthalamic nucleus-deep brain stimulation on subjective and objective sleep parameters in Parkinson's disease. [2021]To explore how subjective and objective sleep parameters respond to bilateral subthalamic nucleus-deep brain stimulation (STN-DBS) in patients with Parkinson's disease (PD).
Improvement of sleep quality in patients with advanced Parkinson's disease treated with deep brain stimulation of the subthalamic nucleus. [2015]Most Parkinson's patients complain about sleep problems. The subjective effect of deep brain stimulation (DBS) of the subthalamic nucleus (STN) on nocturnal disabilities and sleep quality was elucidated by the recently established Parkinson's disease sleep scale (PDSS). The DBS-treated group obtained significant improvement of motor function assessed by the Unified Parkinson's Disease Rating Scale. The mean total PDSS improved significantly after surgery whereas no change was found for the control group. Significant improvements of individual questions were obtained for overall sleep quality and motor symptoms whereas nocturia and daytime sleepiness did not change despite significant reduction of parkinsonian medication.
Assessment of the Effect of Subthalamic Deep Brain Stimulation on Sleep Quality of Parkinson's Disease Patients. [2022]To investigate the effects of subthalamic deep brain stimulation (STN DBS) therapy on sleep quality of Parkinson?s Disease (PD) patients and the relationship between sleep, motor symptoms, depression, and adverse effects of dopamine replacement therapies.
A Phase 2 Randomized Trial of Asleep versus Awake Subthalamic Nucleus Deep Brain Stimulation for Parkinson's Disease. [2021]Asleep deep brain stimulation (DBS) for Parkinson's disease (PD) is being performed more frequently; however, motor outcomes and safety of asleep DBS have never been assessed in a prospective randomized trial.