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Sensing in Sleep Deep Brain Stimulation

Sensing in Sleep and Deep Brain Stimulation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at sleep in people with Parkinson’s disease who already have a Percept RC deep brain stimulation (DBS) device. Participants spend two nights in a sleep lab: one with the device on and one with it off.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be able to understand the study and willing to sign a form agreeing to take part.
  • Be 40 to 80 years old. Men and women can join.
  • Have Parkinson’s disease and a Percept RC DBS device implanted in one of two brain areas called the STN or GPi.
  • Be willing to follow the sleep test plan and turn the DBS device off for one night.
  • Score at least 23 on the Montreal Cognitive Assessment (MoCA), a test of memory and thinking.
  • Be willing to stop sleep medicines, such as benzodiazepines or Ambien, for a 3-day period to let them leave your body.

Who can't join

  • Have a history of severe heart or blood vessel disease, or untreated obstructive sleep apnea, where breathing stops and starts during sleep.
  • Have a history of other brain or spinal cord conditions, such as stroke, multiple sclerosis, tumors, or ALS, or muscle diseases such as muscular dystrophy or myopathy.
  • Have a history of dementia, a condition that harms memory and thinking.
  • Have had changes in medicines that affect dopamine, a brain chemical, in the past month.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (1)

TX