Sensing in Sleep Deep Brain Stimulation

Official title

Sensing in Sleep and Deep Brain Stimulation

Overview

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.

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.

Interventions

• Device Polysomnography ON stimulation then OFF
  Patients will undergo a 2-night Polysomnography (PSG). Stimulation will be set to "ON" stimulation for the 1st PSG night, then will cross over the 2nd PSG study night in the opposite stimulation state. Each subject will act as their own control.
• Device Polysomnography OFF stimulation then ON
  Patients will undergo a 2-night Polysomnography (PSG). Stimulation will be set to "OFF" stimulation for the 1st PSG night, then will cross over the 2nd PSG study night in the opposite stimulation state. Each subject will act as their own control.

Primary outcome measures

• Sensing & Sleep: Parkinson's Disease Sleep Assessment [Time frame: Day 1 to Day 14]
• Motor severity [Time frame: Baseline to Day 14]
• Epworth Sleepiness Scale (ESS) [Time frame: Baseline to Day 14]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Basic science

Study locations

United States · 1 center

• The University of Texas Health Science Center at San Antonio - Brain Health Center — San Antonio

Identifiers

NCT: NCT07636720 · STUDY00000600

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗