Neurostimulation for Parkinson's Disease
Trial Summary
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications. However, it mentions that your motor symptoms should be severe enough despite optimized medical therapy, suggesting you may continue your current Parkinson's medications.
What data supports the effectiveness of the treatment Sub-clinical stimulation for Parkinson's Disease?
Is neurostimulation for Parkinson's disease generally safe for humans?
How does sub-clinical stimulation differ from other treatments for Parkinson's disease?
Sub-clinical stimulation, a form of neurostimulation, is unique because it involves high-frequency electrical stimulation of the subthalamic nucleus, which can improve motor symptoms and emotional processing in Parkinson's disease by enhancing dopamine release and altering neuronal activity. This approach is different from traditional drug treatments like levodopa, which primarily focus on replacing dopamine.13101112
What is the purpose of this trial?
Parkinson's disease (PD) is a neurodegenerative disorder that leads to both motor and non-motor symptoms. Therapies have been developed that effectively target the motor symptoms. Non-motor symptoms are far more disabling for patients, precede the onset of motor symptoms by a decade, are more insidious in onset, have been less apparent to clinicians, and are less effectively treated. Sleep dysfunction is oftentimes the most burdensome of the non-motor symptoms. There are limited options for treating sleep dysfunction in PD, and the mainstay of therapy is the use of sedative-hypnotic drugs without addressing the underlying mechanisms. Patients with PD who demonstrate significant motor fluctuations and dyskinesia are considered for subthalamic nucleus (STN) deep brain stimulation (DBS) surgery. Several studies have reported that STN-DBS also provides benefit for sleep dysregulation. Additionally, local field potentials recorded from STN DBS electrodes implanted for the treatment of PD, have led to the identification of unique patterns in STN oscillatory activity that correlate with distinct sleep cycles, offering insight into sleep dysregulation. This proposal will leverage novel investigational DBS battery technology (RC+S Summit System; Medtronic) that allows the exploration of sleep biomarkers and prototyping of closed-loop stimulation algorithms, to test the hypothesis that STN contributes to the regulation and disruption of human sleep behavior and can be manipulated for therapeutic advantage. Specifically, in PD patients undergoing STN-DBS, the investigators will determine whether STN oscillations correlate with sleep stage transitions, then construct and evaluate sensing and adaptive stimulation paradigms that allow ongoing sleep-stage identification, and induce through adaptive stimulation an increase in duration of sleep stages associated with restorative sleep.
Research Team
Casey Halpern, MD
Principal Investigator
Stanford University
Clete Kushida, MD, PhD
Principal Investigator
Stanford University
John Thompson, PhD
Principal Investigator
University of Colorado, Denver
Aviva Abosch, MD, PhD
Principal Investigator
University of Nebraska
Eligibility Criteria
This trial is for adults aged 21-80 with Parkinson's Disease (PD) who have severe motor symptoms not adequately managed by medication, and are candidates for deep brain stimulation surgery. They must have had PD motor symptoms for at least 4 years, no significant cognitive deficits or depression, and no history of certain medical conditions like seizures or heart disease.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Initial Recovery
Participants undergo standard-of-care STN DBS lead implantation surgery for the treatment of PD
In-patient Sleep Lab
Participants return for 3 nights of STN LFP recordings with concurrent PSG, EMG, EOG, actigraphy, and video-EEG to establish a physiological sleep baseline and test sub-clinical stimulation
Adaptive Stimulation Implementation
Implementation of adaptive stimulation algorithm developed in Aim 1 during nighttime sleep over 3 weeks of in-home sleep
Follow-up
Participants are monitored for safety and effectiveness after adaptive stimulation
Treatment Details
Interventions
- Sub-clinical stimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Nebraska
Lead Sponsor
Stanford University
Collaborator
University of Colorado, Denver
Collaborator
University of Pennsylvania
Collaborator