Sensing in Sleep Deep Brain Stimulation
Purpose
Participants in this study have Parkinson's Disease and already have a device, called the Percept RC Deep Brain Stimulation device implanted. People with Parkinson's disease often have issues related to sleep such as bad quality of sleep, waking up often and sleep apnea (breathing stops and starts during sleep). For this study, participants will be sleeping overnight in the study sleep lab for two nights. One night, Deep Brain Stimulation (DBS) device turned on and one night with the DBS off, either in this order or the reverse.
Conditions
- Parkinson's Disease and Parkinsonism
- Dyssomnia
Eligibility
- Eligible Ages
- Between 40 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Ability of subject to understand and the willingness to sign a written informed consent document. 2. Males and females; Age 40-80 3. Subjects with the diagnosis of idiopathic PD consistent with the United Kingdom Parkinson Disease society brain bank criteria, or documented diagnosis of Parkinson Disease who have a Deep Brain Implant, Percept RC device to subthalamic nucleus (STN) or Globus pallidus internus (GPi). 4. Willingness to adhere to the PSG regimen and turn DBS off for one night. 5. A score of ≥23 on the Montreal Cognitive Assessment (MoCA) 6. Be willing to stop any sleep hypnotics such as benzodiazepines and Ambien, with a 3 day washout period.
Exclusion Criteria
- History of severe cardiovascular disease, untreated obstructive sleep apnea (OSA). 2. History of other neurological disorders affecting the central nervous system such as stroke, multiple sclerosis, tumors, amyotrophic lateral sclerosis or muscle disease such as muscular dystrophy, myopathy. 3. History of Dementia. 4. Report dopaminergic medication changes in the past month.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- This will be a single center, prospective, randomized cross over (On vs OFF) clinical trial
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
- Masking Description
- The subject will be randomized after completion of the baseline visit. This study will utilize block randomization with permuted blocks in a 1:1 ratio. Individuals will be assigned to either Group 1 or Group 2 after baseline assessment. The randomization will be predetermined, and the allocation will be concealed to the patient only.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental STN-DBS Group |
Participants diagnosed with Parkinson's Disease who have subthalamic nucleus (STN) deep brain stimulation as a primary target for their condition |
|
|
Experimental GPi-DBS Group |
Participants diagnosed with Parkinson's Disease who have Globus Pallidus internus (GPi) deep brain stimulation as a primary target for their condition. |
|
Recruiting Locations
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Health Science Center at San Antonio
Detailed Description
This prospective study will use the Percept sensing tools, collectively referred to as Brainsense, to correlate STN and GPi-LFP activity to sleep stages, characterize sleep events and evaluate the effects of DBS stimulation on sleep quality and sleep events. This study may help identify and validate novel biomarkers to assess sleep quality, REM behavior disorder,sleep fragmentation, and awakenings in patients with Parkinson's Disease, which will support overall DBS' efficacy beyond motor symptoms, and supplement interventions to improve sleep, and potentially also guide more effective DBS programming.