18 Participants NeededMy employer runs this trial

Adaptive Deep Brain Stimulation for Parkinson's Disease

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
Must be taking: Antiparkinsonian medications
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 trial aims to improve sleep quality for people with Parkinson's disease who already use adaptive deep brain stimulation (aDBS). Researchers will collect sleep data and test three different aDBS settings to identify the most effective one for better sleep. Participants will use these settings at home and provide feedback, which will help determine the optimal setup. Ideal candidates for this trial have Parkinson's, already use specific DBS equipment, and have maintained stable treatment settings for their motor symptoms for at least a month. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance sleep quality for Parkinson's patients.

What prior data suggests that this adaptive deep brain stimulation is safe for Parkinson's Disease patients?

Research has shown that adaptive Deep Brain Stimulation (aDBS) is generally safe for people with Parkinson's Disease. Studies have found no serious problems related to the device itself, and most minor issues resolved during the setup and adjustment phases of aDBS.

Additionally, aDBS is well-tolerated over long periods and effectively controls symptoms like tremors and slow movement. This means aDBS can help manage the physical symptoms of Parkinson's without causing significant new issues.

Overall, current research suggests that aDBS is a safe treatment option for those considering it.12345

Why are researchers excited about this trial?

Adaptive Deep Brain Stimulation (aDBS) is unique because it offers a personalized approach to treating Parkinson's Disease. Traditional deep brain stimulation (DBS) delivers continuous electrical impulses to the brain, but aDBS adapts its stimulation in real-time based on the patient's brain activity. This means it can potentially reduce side effects and improve symptom control by only delivering stimulation when needed. Researchers are excited about aDBS because it targets the brain more precisely, which could lead to better outcomes for patients with fewer complications.

What evidence suggests that adaptive Deep Brain Stimulation is effective for Parkinson's Disease?

Research has shown that adaptive deep brain stimulation (aDBS), which participants in this trial will receive, holds promise for treating Parkinson's disease. Studies have found that aDBS can improve movement symptoms by up to 66%, allowing patients better control over their movements. Patients using aDBS also experience more "on-time," periods when their symptoms are well-managed, and they face fewer side effects compared to continuous deep brain stimulation (cDBS). Some reports mention that aDBS enhances overall well-being and movement. However, some studies have not found a significant short-term benefit of aDBS over cDBS. Despite this, the ability to personalize aDBS settings offers hope for better managing Parkinson’s symptoms.678910

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Data Collection

Baseline sleep and basal ganglia physiology data are collected to inform aDBS parameter changes

1 week

In-home Monitoring

15 nights of in-home monitoring of subjective and objective sleep quality using 3 different sleep-tailored aDBS settings

2 weeks

Polysomnography

Participants undergo repeat polysomnography in the optimized sleep-tailored aDBS mode to compare aDBS behavior and sleep architecture to baseline

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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+

Citations

Personalised Brain Stimulation for Parkinson's Disease

New research shows adaptive deep brain stimulation is safe and effective in Parkinson care. Keep reading to see future treatment potential.

Controlling Parkinson's Disease With Adaptive Deep Brain ...

Motor scores were improved by 66% and 50% during aDBS … clinical outcome was 29% (p=0.03) and 27% (p=0.005) better

Personalized Neurostimulation Effective for Parkinson's ...

Exploratory clinical outcomes suggested improvements in on and off time, as well as in motor severity with DT-aDBS and selected mode compared to ...

A Personalized Approach to Parkinson's Disease Management

Bilateral adaptive deep brain stimulation is effective in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2016;87(7):717-721. doi:10.1136/jnnp-2015 ...

Study on Adaptive DBS for Parkinson's Disease Shows the ...

For both single- and dual-threshold aDBS, the mean on-time without troublesome dyskinesia slightly improved compared to continuous DBS.

Personalized Neurostimulation Effective for Parkinson's ...

There were no serious device-related adverse events, and all but one relating to stimulation resolved during the aDBS setup and adjustment phase ...

Study on Adaptive DBS for Parkinson's Disease Shows the ...

For both single- and dual-threshold aDBS, the mean on-time without troublesome dyskinesia slightly improved compared to continuous DBS.

P960009/S478 Summary of Safety and Effectiveness (SSED)

The current supplement (S478) introduces a new optional programming feature called adaptive deep brain stimulation (aDBS) for Parkinson's Disease in existing ...

Personalized chronic adaptive deep brain stimulation ... - PMC

Adaptive stimulation improved motor symptoms that persisted on clinically optimized continuous stimulation. We compared aDBS to clinically optimized cDBS for a ...

Adaptive deep brain stimulation in the news

"Current DBS can be life changing and has the promise to be even more effective by being more responsive to the needs of the individual.