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Adaptive Deep Brain Stimulation for Parkinson's Disease

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
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?

This is an interventional study of a cohort of patients with PD treated with DBS, and already utilizing adaptive DBS (dual threshold mode). In Aim 1, we will obtain baseline sleep and basal ganglia physiology data to inform aDBS parameter changes. Aim 2 involves 15 nights of in-home monitoring of subjective and objective sleep quality, during which participants will use 3 different sleep-tailored aDBS settings at night only. Participant preference among these 3 settings will determined the 'optimized sleep-tailored aDBS mode'. Participants will undergo repeat polysomnography, while in the optimized sleep-tailored aDBS mode, to compare aDBS behavior and sleep architecture to the baseline (Aim 1) sleep study.

Are You a Good Fit for This Trial?

This trial is for people with Parkinson's disease who already have a deep brain stimulator (DBS) and are using adaptive DBS. Participants must be able to take part in sleep studies at home and in the clinic.

Inclusion Criteria

I have been on the same dose of Parkinson's medication for at least 4 weeks.
I am able to use the Waveband app.
My Parkinson's disease is at stage 2 or 3 while on medication or DBS.
See 4 more

Exclusion Criteria

I have been clinically diagnosed with dementia.
Shift workers
Any condition that in the opinion of the investigator precludes successful or safe completion of study procedures
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • adaptive Deep Brain Stimulation (aDBS)

Trial Overview

Researchers are testing different nighttime settings of adaptive deep brain stimulation (aDBS) to see how they affect sleep quality in people with Parkinson's disease. Each participant will try three settings at night, then use their preferred one for further study.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: aDBSExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

Colorado Clinical and Translational Sciences Institute

Collaborator

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials
394
Recruited
404,000+

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