Neurostimulation for Sleep Problems in Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
Parkinson's Disease (PD) is the second most common of the age-related neurodegenerative disorders, affecting over 1,900 adults per 100,000 over the age of 80 in the US. The prevalence of sleep dysfunction in PD is estimated at nearly 80-90% which includes sleep fragmentation, insomnia, rapid eye movement (REM or dream sleep) Sleep Behavior Disorder (RBD), Restless legs syndrome (RLS), periodic limb movement, excessive daytime sleepiness, and sleep apnea. Sleep is vital to homeostasis, cognition, and nervous system repair. The dysfunctional sleep accompanying PD adversely affects both motor and non-motor symptoms, resulting in diminished quality of life for both patients and caregivers, including impairments in mood and behavior, and increased morbidity and mortality. Knowledge of sleep phenomenology and pathology in humans has largely been informed by analysis of non-invasive scalp electroencephalogram (EEG), and despite the profound importance of sleep, the underlying neural circuits important for controlling sleep and wakefulness in humans remain poorly understood.This study assesses whether adaptive stimulation of the Subthalamic Nucleus (STN) drives changes in sleep episode maintenance and improves sleep quality. Participants are adults with PD 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). Prior to surgery, participant sleep patterns will be assessed with questionnaires and monitored with a non-invasive watch-like device. Approximately four months after implantation surgery, participants will each receive 2 1-week deep brain stimulation (DBS) treatments and 1 1-week control session with no DBS in random order. Sleep patterns will again be monitored during the treatments and compared to the patterns before surgery.
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.
Is deep brain stimulation safe for humans?
How is the treatment Deep Brain Stimulation (DBS) unique for sleep problems in Parkinson's disease?
What data supports the effectiveness of the treatment Deep Brain Stimulation for sleep problems in Parkinson's Disease?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Surgery Monitoring
Participants complete clinical sleep questionnaires and wear an actigraphy watch to monitor sleep architecture and fragmentation
Post-Surgery Optimization
Participants undergo standard-of-care Deep Brain Stimulation surgery and optimization of Parkinson's medication and DBS parameters
Treatment
Participants undergo randomized, double-blind nocturnal stimulation with adaptive, open-loop, and no stimulation conditions
Follow-up
Participants are monitored for changes in sleep quality and efficiency using actigraphy and sleep questionnaires
What Are the Treatments Tested in This Trial?
Interventions
- Deep Brain Stimulation
Deep Brain Stimulation is already approved in United States, European Union, Canada for the following indications:
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
- Stroke-related motor deficits (under investigation)
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Nebraska
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator