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
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