20 Participants NeededMy employer runs this trial

Deep Brain Stimulation for Parkinson's Disease

EO
OB
Overseen ByOmalys Biggs Rodriguez
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center at San Antonio
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

EO

Eleni O Vaou, MD

Principal Investigator

The University of Texas Health Science Center at San Antonio

PC

Pablo Coss, MD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for people with Parkinson's disease who already have a Percept RC Deep Brain Stimulation (DBS) device implanted. Participants should be able to spend two nights in a sleep lab.

Inclusion Criteria

I have Parkinson's disease diagnosed by a doctor or have a Percept RC brain implant.
Willingness to adhere to the PSG regimen and turn DBS off for one night
I am willing to stop taking sleep medications like Ambien or benzodiazepines for 3 days.
See 3 more

Exclusion Criteria

I have untreated obstructive sleep apnea.
I have a history of neurological or muscle diseases like stroke or muscular dystrophy.
History of Dementia
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants will sleep overnight in the study sleep lab for two nights, one with DBS on and one with DBS off

2 nights
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Deep Brain Stimulation (DBS)

Trial Overview

The study tests how turning the DBS device on or off affects sleep quality in people with Parkinson's. Each participant will spend one night sleeping with the DBS on and another night with it off, monitored by sleep studies.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: STN-DBS GroupExperimental Treatment2 Interventions
Group II: GPi-DBS GroupExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials
486
Recruited
92,500+