Deep Brain Stimulation for Parkinson's Disease
(DREAMS-PD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how different settings of deep brain stimulation (DBS) affect sleep in people with Parkinson's disease. Participants will try three DBS settings at night: no stimulation, reduced stimulation, and optimal clinical stimulation. Researchers will monitor sleep with a special headband to assess how each setting impacts sleep quality and brain activity. The trial seeks participants who have Parkinson's disease, already use a specific DBS device, and experience sleep issues. As an unphased trial, it offers a unique opportunity to contribute to understanding how DBS settings can improve sleep quality in Parkinson's patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are taking sleep-supporting medications, your dosage must be stable for at least 30 days before joining.
What prior data suggests that this deep brain stimulation is safe for Parkinson's disease?
Research has shown that using deep brain stimulation (DBS) at night for Parkinson's disease is generally well-tolerated. Studies indicate that adjusting DBS settings can improve symptoms and overall well-being. For instance, one study found that adaptive DBS, which automatically adjusts the stimulation, significantly enhanced patients' well-being.
Another study examined various DBS settings and found that optimizing these settings, even remotely, can accelerate symptom relief. This suggests that the technology is becoming more adaptable and effective.
Although these studies do not provide specific information on side effects, the existing use of DBS in treating Parkinson's suggests it is generally safe. DBS has been safely used for other Parkinson's symptoms, so experimenting with different settings at night appears promising in terms of safety.12345Why are researchers excited about this trial?
Researchers are excited about nighttime deep brain stimulation (DBS) with varying amplitude settings for Parkinson's disease because it offers a new approach to improving sleep quality. Unlike traditional treatments that primarily focus on managing motor symptoms, this method targets sleep disturbances, which are common in Parkinson's patients. By using a Medtronic Percept™ DBS system with adjustable settings, this treatment aims to personalize therapy by optimizing stimulation levels during sleep. This could lead to better overall management of Parkinson's symptoms, enhancing quality of life for patients.
What evidence suggests that nighttime deep brain stimulation might be an effective treatment for Parkinson's disease?
Research has shown that deep brain stimulation (DBS) might help people with Parkinson's disease sleep better. In this trial, participants will experience various nighttime-only DBS settings, including no stimulation, reduced stimulation, and optimal clinical stimulation. One study found that DBS increased the number of sleep spindles, bursts of brain activity during the N2 sleep stage, which is crucial for restful sleep. People with Parkinson's had more sleep spindles with lower levels of DBS. Other studies suggest that DBS can improve sleep efficiency, meaning people get better quality sleep. Overall, DBS has shown promise not only in managing movement symptoms but also in enhancing sleep for Parkinson's patients.36789
Are You a Good Fit for This Trial?
This trial is for adults over 18 with idiopathic Parkinson's Disease who have had a specific type of Deep Brain Stimulation (DBS) device implanted and optimized for at least three months. Participants should be able to walk on their own, give informed consent, and if they're taking sleep meds, the dose must be stable for 30 days.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a 6-week in-home monitoring protocol with three different nighttime-only DBS stimulation settings in a randomized 2-week crossover design
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nighttime Deep Brain Stimulation with Varying Amplitude Settings
Trial Overview
The study is testing how different amplitude settings during nighttime DBS affect patients with Parkinson's. It's an exploratory trial where participants will experience varying DBS settings in a random order to see what works best during sleep.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Participants with Parkinson's disease implanted with a Medtronic Percept™ deep brain stimulation (DBS) system will undergo a 6-week in-home monitoring protocol. Each participant will be exposed to three different nighttime-only DBS stimulation settings in a randomized 2-week crossover design: (1) no stimulation (0% amplitude), (2) reduced stimulation (50% amplitude), and (3) optimal clinical stimulation. Sleep metrics will be collected nightly using the Dreem Headband wearable electroencephalogram (EEG) device. One night of polysomnography will also be conducted to validate the wearable. Subcortical local field potentials (LFPs) from the subthalamic nucleus will be recorded to assess band power and coherence during different stimulation settings and sleep stages. The study aims to evaluate the effect of DBS settings on sleep efficiency, spectral features of neural activity, and their correlation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor
Beacon Biosignals
Industry Sponsor
American Parkinson's Disease Association, Inc
Collaborator
Citations
Effects of deep brain stimulation on quantitative sleep ...
DBS likely has a beneficial therapeutic effect on sleep in PD, which may be due in part to increased sleep spindle density during N2 sleep.
Sleep spindle variation in patients with Parkinson's disease ...
Our analysis indicates that a single night of sub-optimal STN stimulation significantly increases sleep spindle density in Parkinson's disease patients.
Chronic adaptive deep brain stimulation for Parkinson's ...
General movement improved in five of seven patients, with significant effects in three. Dyskinesia severity decreased in four patients (one ...
Tailoring deep brain stimulation for sleep: using actigraphy to ...
If DBS can target this disruption and improve patient sleep, it has a real opportunity to move beyond controlling symptoms and become a disease- ...
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ctv.veeva.com
ctv.veeva.com/study/deep-brain-stimulation-neural-recordings-of-varied-stimulation-during-sleep-in-parkinsons-diseaseDeep Brain Stimulation Neural Recordings of Varied ...
While DBS has demonstrated benefits in enhancing sleep efficiency and architecture, the mechanisms by which this might occur, as well as the ...
Chronic adaptive deep brain stimulation for Parkinson's ...
Patients were not blinded to the stimulation mode. On the group level, overall well-being significantly improved with adaptive DBS (p = 0.007), ...
Accelerated symptom improvement in Parkinson's disease ...
This study investigated whether optimizing DBS settings remotely via a mobile application leads to faster symptom improvements.
Chronic Adaptive Deep Brain Stimulation in Parkinson's ...
In the five patients on chronic aDBS, unblinded MDS-UPDRS III assessment showed an average 35% greater motor improvement compared with cDBS.
Adaptive Deep Brain Stimulation for sleep stage targeting ...
We report a novel approach to sleep modulation in PD using a fully automated, adaptive DBS algorithm that adjusts stimulation amplitude according to sleep stage ...
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