Deep Brain Stimulation for Sleep Issues in Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how deep brain stimulation (DBS), a treatment involving electrical impulses to the brain, affects sleep problems in people with Parkinson's disease. Sleep disturbances can significantly impact daily life, and the study will help identify how DBS influences brain activity related to sleep. Participants will undergo DBS treatment in different sequences to observe changes in sleep behavior and brain function. The trial suits those diagnosed with Parkinson's disease who are scheduled for DBS surgery or have already undergone the procedure but haven't had their first programming session yet.
As an unphased trial, this study offers participants a unique opportunity to contribute to pioneering research on improving sleep quality in Parkinson's disease.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that deep brain stimulation (DBS) is generally safe for people with Parkinson's disease, provided they undergo careful pre-procedure evaluation. Studies have found that the procedure carries a low risk, though there is a slight increase in hospital visits afterward. Most risks, such as infections, are rare.
One study on safety found that infections were the most common serious issue, yet they remain uncommon. While some complications, like bleeding in the brain or stroke, can occur, they are not frequent. Additionally, DBS has greatly improved movement and is considered safe for older patients. Overall, DBS is well-tolerated and offers benefits that often outweigh the risks for many patients.12345Why are researchers excited about this trial?
Researchers are excited about these treatments because sleep-specific Deep Brain Stimulation (DBS) therapy offers a novel approach for managing Parkinson's disease symptoms, particularly those affecting sleep. Unlike standard treatments like medications or general DBS that focus on daytime motor symptoms, this therapy targets brain activity specifically during sleep. This tailored approach could lead to significant improvements in sleep quality, potentially enhancing overall quality of life for individuals with Parkinson's disease. Additionally, the ability to switch between "ON" and "OFF" DBS states in the study allows researchers to closely examine the direct effects of the therapy, offering insights into optimizing treatment for better outcomes.
What evidence suggests that this trial's treatments could be effective for sleep-wake disturbances in Parkinson's disease?
Research has shown that deep brain stimulation (DBS) can help people with Parkinson's disease. Studies have found that DBS improves movement problems and reduces the need for medication, enhancing quality of life. For instance, improvements in movement have been observed even ten years after treatment. Patients often report feeling and moving much better after DBS. In this trial, participants will experience both "ON DBS followed by OFF DBS" and "OFF DBS followed by ON DBS" treatment arms. Although this trial focuses on sleep, these findings suggest DBS might also help with sleep problems related to Parkinson's.23678
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-surgery Assessment
Participants undergo standard-of-care pre-surgery UPDRS-III exams and sleep-specific exams
DBS Surgery and Initial Study Procedures
Participants undergo DBS surgery in two stages with additional research procedures during lead implantation
Post-surgery Sleep Assessment
Baseline sleep data collected using actigraphy watch prior to clinical programming
Follow-up
Participants are monitored for sleep quality and clinical outcomes at 6 and 12 months post-surgery
What Are the Treatments Tested in This Trial?
Interventions
- Clinically optimized deep brain stimulation
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
Citations
Long-term outcomes following deep brain stimulation for ...
Conclusions: DBS for PD is associated with a 10-year survival rate of 51%. Survey data suggest that while DBS does not halt disease ...
DBS Outcomes | Brain Institute
Benefits from asleep surgery: A 2017 OHSU study found that people who had asleep DBS had better outcomes six months later than people who had awake DBS.
3.
ufhealth.org
ufhealth.org/news/2025/uf-led-study-shows-deep-brain-stimulation-benefits-for-parkinsons-patientsUF-led study shows deep brain stimulation benefits for ...
For the first time, we can clearly see that the benefits of DBS, improvements in motor symptoms, reduced medication needs and better quality of ...
How Long Does Deep Brain Stimulation Give Patients ...
Results. We showed that patients with PD, ET, and dystonia maintain a considerable long-term benefit in motor scores seven to ten years after implant, ...
Five-Year Outcomes from Deep Brain Stimulation of the ...
From screening, a significant improvement in motor outcomes is reported 1 year after deep brain stimulation (DBS) and sustained out to 5 years.
Deep brain stimulation in PD: risk of complications ...
It is found that, when candidates are carefully screened, DBS is a relatively low-risk procedure, but rate of hospitalization is somewhat increased for DBS ...
Safety and efficiency of deep brain stimulation in the ...
Our results suggest that neurosurgical robot-assisted DBS is accurate, safe, and efficient, making it suitable for elderly patients with PD.
Deep brain stimulation
Surgery risks · Misplacement of the wires with the electrodes, known as leads. · Bleeding in the brain. · Stroke. · Infection. · Trouble breathing.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.