Sensing in Sleep Deep Brain Stimulation
Recruiting · NCT07636720 · Interventional (participants receive a specific treatment) · Lead sponsor: The University of Texas Health Science Center at San Antonio
View the official record on ClinicalTrials.gov →Interventions studied
Polysomnography OFF stimulation then ONPolysomnography ON stimulation then OFF
What this trial is about
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.
Who can take part
Age range
40 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Males and females; Age 40-80
- 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).
- Willingness to adhere to the PSG regimen and turn DBS off for one night.
- A score of ≥23 on the Montreal Cognitive Assessment (MoCA)
- 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).
- 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.
- History of Dementia.
- Report dopaminergic medication changes in the past month.
Where it is running
1 location listed across 1 US state.
- The University of Texas Health Science Center at San Antonio - Brain Health Center - San Antonio, Texas, United States