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Sensing in Sleep Deep Brain Stimulation

NCT07636720 · The University of Texas Health Science Center at San Antonio
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Official title
Sensing in Sleep and Deep Brain Stimulation
About this study
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.
Eligibility criteria
Inclusion Criteria: 1. 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: 1. 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
Enrollment target: 20 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2026-02-27
Estimated completion: 2028-02-01
Last updated: 2026-06-09
Interventions
Device: Polysomnography ON stimulation then OFFDevice: Polysomnography OFF stimulation then ON
Primary outcomes
  • Sensing & Sleep: Parkinson's Disease Sleep Assessment (Day 1 to Day 14)
  • Motor severity (Baseline to Day 14)
  • Epworth Sleepiness Scale (ESS) (Baseline to Day 14)
Sponsor
The University of Texas Health Science Center at San Antonio · other
Contacts & investigators
ContactEleni O Vaou, MD · contact · vaou@uthscsa.edu · 210 450 8048
ContactOmalys Biggs Rodriguez · contact · biggsrodrigu@uthscsa.edu · 210-450-7547
InvestigatorEleni O Vaou, MD · principal_investigator, The University of Texas Health Science Center at San Antonio
InvestigatorPablo Coss, MD · principal_investigator, The University of Texas Health Science Center at San Antonio
All locations (1)
The University of Texas Health Science Center at San Antonio - Brain Health CenterRecruiting
San Antonio, Texas, United States
Sensing in Sleep Deep Brain Stimulation · TrialPath