Neurostimulation for Sleep Problems in Parkinson's Disease

Recruiting at 3 trial locations

Overseen By Dulce Maroni, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Must not be taking: Anticoagulants

Disqualifiers: Seizures, Heart disease, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a type of brain stimulation can improve sleep quality in people with Parkinson's disease. Many individuals with Parkinson's experience sleep issues, impacting daily life and overall well-being. The study uses a device to stimulate the brain in various ways, comparing the effects on sleep. Ideal candidates are those with Parkinson's who have not found sufficient relief from motor symptoms and are scheduled to receive a deep brain stimulator implant. Researchers will monitor participants' sleep before and after the treatment to assess any differences. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance sleep for those with Parkinson's.

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 prior data suggests that this neurostimulation technique is safe for improving sleep in Parkinson's Disease?

A previous study found adaptive deep brain stimulation (aDBS) to be a safe and effective treatment for people with Parkinson's disease. Specifically, the study showed that aDBS significantly improved patients' overall well-being. Another study reported that aDBS reduced the energy needed for effective therapy by about 48-74%, suggesting it might be easier for patients to handle.

Open-loop deep brain stimulation (DBS) is a well-known treatment for Parkinson's. Research has shown it can improve Parkinson's symptoms by 60-80% and help reduce the need for medication over many years. Both aDBS and open-loop DBS have been used safely in people with Parkinson's disease, making them promising options for managing symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about deep brain stimulation (DBS) for addressing sleep problems in Parkinson's Disease because it offers a novel approach to managing symptoms beyond traditional medication or physical therapy. Unlike conventional DBS, which uses a fixed setting, adaptive DBS is tailored to the individual's brain activity, potentially improving sleep quality by dynamically adjusting stimulation. This personalized approach could optimize treatment effectiveness and minimize side effects, providing a more refined solution for patients struggling with sleep disturbances associated with Parkinson's.

What evidence suggests that this trial's treatments could be effective for sleep problems in Parkinson's Disease?

This trial will compare different types of deep brain stimulation (DBS) for sleep problems in Parkinson's disease. Research has shown that adaptive deep brain stimulation (aDBS), which participants in one arm of this trial will receive, can effectively improve movement problems in people with Parkinson's disease. Evidence also suggests it may enhance overall well-being, although improvements in sleep quality are not always significant. In contrast, open-loop deep brain stimulation (DBS), which participants in another arm will receive, has increased total sleep time and reduced sleep problems in Parkinson’s patients. It appears to improve sleep quality and lessen daytime tiredness. Both methods target the subthalamic nucleus (STN), a part of the brain that helps control movement and sleep, aiming to improve both sleep and movement issues. ^{2 3 6 7 8}

Who Is on the Research Team?

Aviva Abosch, MD, PhD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Deep Brain Stimulation

Trial Overview 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.

How Is the Trial Designed?

Group I: Adaptive Deep Brain Stimulation Experimental Treatment 1 Intervention

Participants will be given adaptive deep brain stimulation (DBS) during one week of at-home night sleep.

Group II: Open-loop Deep Brain Stimulation Active Control 1 Intervention

Participants will be given open-loop deep brain stimulation (DBS) (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 Deep Brain Stimulation Active Control 1 Intervention

Deep brain stimulation (DBS) 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

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

Bilateral subthalamic nucleus-deep brain stimulation (STN-DBS) significantly improved subjective sleep quality in Parkinson's disease patients, as measured by various scales, with notable improvements observed at the 6-month follow-up.

While STN-DBS did not significantly alter objective sleep parameters from polysomnography, it did lead to a reduction in rapid eye movement sleep latency, indicating some changes in sleep patterns, while subjective improvements in sleep quality were linked to reduced medication needs and better motor function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quantitative analysis of the effect of bilateral subthalamic nucleus-deep brain stimulation on subjective and objective sleep parameters in Parkinson's disease. Yin, Z., Bai, Y., Guan, B., et al.[2021]

Asleep deep brain stimulation (DBS) for Parkinson's disease showed a mean motor improvement of 52.3% on the Unified Parkinson's Disease Rating Scale, which is comparable to the 47.0% improvement seen in the awake group, suggesting that asleep DBS is an effective alternative.

The study found no serious complications related to the surgery, with only a subcutaneous hematoma reported, indicating that asleep DBS may be a safe option for patients undergoing this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase 2 Randomized Trial of Asleep versus Awake Subthalamic Nucleus Deep Brain Stimulation for Parkinson's Disease. Engelhardt, J., Caire, F., Damon-Perrière, N., et al.[2021]

In a study of 40 Parkinson's disease patients undergoing subthalamic deep brain stimulation (STN-DBS), 45% reported significant improvement in sleep quality at 6 months, although this improvement was not statistically significant at 12 months.

The most common benefits included better overall sleep quality and maintenance, but some patients experienced new-onset daytime sleepiness, indicating that while STN-DBS can improve sleep, the effects can vary widely among individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in Parkinson's disease sleep symptoms and daytime somnolence after bilateral subthalamic deep brain stimulation in Parkinson's disease. Kharkar, S., Ellenbogen, JR., Samuel, M., et al.[2020]

Subthalamic deep brain stimulation (STN DBS) significantly improved sleep quality in Parkinson's Disease patients, as evidenced by better scores on various sleep assessment tools after 8 months of therapy.

The improvements in sleep quality were attributed to the neuromodulatory effects of STN DBS, which occurred independently of motor symptoms, depression levels, and dopamine replacement therapy dosages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the Effect of Subthalamic Deep Brain Stimulation on Sleep Quality of Parkinson's Disease Patients. Oner, OG., Sunter, G., Jafarova, S., et al.[2022]

The study developed an adaptive Deep Brain Stimulation (DBS) algorithm that can adjust stimulation based on specific sleep stages, particularly targeting the N3 NREM sleep stage, which is crucial for restorative sleep.

Results from two participants showed high accuracy in classifying N3 sleep stages using intracranial electrocorticography, demonstrating the potential of this technology to improve sleep quality in individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive Deep Brain Stimulation for sleep stage targeting in Parkinson's disease. Smyth, C., Anjum, MF., Ravi, S., et al.[2023]

In a study of 11 patients with advanced Parkinson's disease, chronic bilateral subthalamic stimulation (STN-DBS) led to significant improvements in subjective sleep quality, as measured by the Pittsburgh Sleep Quality Index (PSQI).

Polysomnography results indicated that STN-DBS increased the longest period of uninterrupted sleep and decreased sleep fragmentation, suggesting that the therapy enhances overall sleep architecture despite an increase in nocturnal mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep symptoms and polysomnographic architecture in advanced Parkinson's disease after chronic bilateral subthalamic stimulation. Iranzo, A., Valldeoriola, F., Santamaría, J., et al.[2022]

Deep brain stimulation (DBS) of the subthalamic nucleus significantly improves sleep quality and motor function in Parkinson's patients, as measured by the Parkinson's Disease Sleep Scale (PDSS) and the Unified Parkinson's Disease Rating Scale.

While overall sleep quality improved after DBS surgery, issues like nocturia and daytime sleepiness remained unchanged, even with a reduction in Parkinson's medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of sleep quality in patients with advanced Parkinson's disease treated with deep brain stimulation of the subthalamic nucleus. Hjort, N., Østergaard, K., Dupont, E.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12537409/

Evaluation of the therapeutic effect of adaptive deep brain ... Previous studies have demonstrated that adaptive deep brain stimulation (aDBS) can effectively improve motor symptoms in Parkinson's disease ...

2. nature.com nature.com/articles/s41531-025-01124-7

Chronic adaptive deep brain stimulation for Parkinson's ... On the group level, overall well-being significantly improved with adaptive DBS (p = 0.007), and there was a non-significant trend toward ...

3. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2839117

Long-Term Personalized Adaptive Deep Brain Stimulation ... This nonrandomized clinical trial evaluates the use of adaptive deep brain stimulation in Parkinson disease.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5600204/

Effects of Subthalamic Nucleus Deep Brain Stimulation on ... Although well tolerated, low‐frequency STN DBS did not improve objective sleep in PD. Remarkably, objective measures of sleep were not worse with DBS off. These ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X2400007X

Single threshold adaptive deep brain stimulation in ... Results. Our findings reveal that changes in the onset time control the extent of beta power suppression achievable with single threshold adaptive stimulation ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P960009S478B.pdf

P960009/S478 Summary of Safety and Effectiveness (SSED) The current supplement (S478) introduces a new optional programming feature called adaptive deep brain stimulation (aDBS) for Parkinson's Disease in existing ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11408616/

Sensing data and methodology from the Adaptive DBS ... Short-term studies of aDBS in people with PD suggest an estimated ~48–74% reduction in stimulation energy required to achieve effective therapy ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X2030214X

Acute effects of adaptive Deep Brain Stimulation in ... Beta-based adaptive Deep Brain Stimulation (aDBS) is effective in Parkinson's disease (PD), when assessed in the immediate post-implantation phase.