Image

Sensing in Sleep Deep Brain Stimulation

Sensing in Sleep Deep Brain Stimulation

Recruiting
40-80 years
All
Phase N/A

Powered by AI

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.

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.

Eligibility

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 details
    Parkinson's Disease and Parkinsonism
    Dyssomnia

NCT07636720

The University of Texas Health Science Center at San Antonio

27 June 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.