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Adaptive Deep Brain Stimulation for Parkinson's Disease

(Auto aDBS Trial)

RC
RM
Overseen ByResearch Manager
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
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 tests a new approach to deep brain stimulation (DBS) for people with Parkinson's disease. Traditional DBS delivers a constant electrical signal to the brain, which can sometimes be excessive or insufficient. The new method, called adaptive DBS, automatically adjusts the signal based on real-time brain activity. This study targets individuals who have undergone DBS surgery but still experience movement problems. Participants should have tried traditional DBS and continue to face issues like ongoing movement fluctuations.

As an unphased trial, this study provides a unique opportunity to explore innovative treatment options that could enhance participants' quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the focus is on adjusting deep brain stimulation settings, it's possible that you may continue your current medications unless advised otherwise by the study team.

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

Research has shown that adaptive deep brain stimulation (aDBS) for Parkinson's disease is generally well-tolerated. Earlier studies found aDBS promising because it adjusts stimulation based on real-time needs, helping to avoid excessive or insufficient stimulation. Reports indicate that patients did not experience more side effects compared to the traditional constant DBS (cDBS) method.

The Medtronic Percept device, used in both aDBS and cDBS, has FDA approval for treating Parkinson's disease, indicating its safety for use in people. This approval suggests that any side effects are manageable and not significantly different from standard treatment methods. Overall, both aDBS and cDBS are considered safe options for managing Parkinson's disease symptoms.

Why are researchers excited about this trial?

Researchers are excited about the trial for adaptive Deep Brain Stimulation (aDBS) in Parkinson's disease because it offers a tailored approach that automatically adjusts in real-time to the patient's brain signals. Unlike the standard continuous DBS (cDBS), which delivers a constant level of stimulation, aDBS uses clever technology to sense beta-band neural activity and modify the stimulation accordingly. This adaptive method could potentially improve symptom management and reduce side effects by providing just the right amount of stimulation as needed, making it a promising advancement in personalized treatment for Parkinson's disease.

What evidence suggests that adaptive DBS is effective for Parkinson's disease?

Research has shown that adaptive deep brain stimulation (aDBS), one of the treatments studied in this trial, holds promise for people with Parkinson's disease. Studies have found that aDBS can greatly improve symptoms like tremors, stiffness, and slow movements. This technology adjusts stimulation based on real-time brain signals, better meeting the patient's needs throughout the day. After a month of use, 98% of patients preferred aDBS over traditional methods, highlighting its effectiveness. Long-term studies confirm that aDBS is safe and well-tolerated by patients. Overall, aDBS offers a more personalized and effective way to manage Parkinson's symptoms. Meanwhile, the trial will also evaluate open-loop continuous deep brain stimulation (cDBS) as an active comparator to assess its effectiveness and safety.12345

Who Is on the Research Team?

SL

Simon Little, MBBS,PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for people with Parkinson's disease who already have a Medtronic Percept deep brain stimulator implanted. Participants should be adults and able to take part in study activities.

Inclusion Criteria

Has available cDBS Timeline LFP and stimulation data lasting at least 1 day
I am between 25 and 75 years old.
To be enrolled in the clinical trial phase, patient must consent to reverting back to baseline cDBS settings for all required cDBS testings
See 6 more

Exclusion Criteria

Any personality or mood symptoms that study personnel believe will interfere with study requirements
I do not have untreated severe depression or recent suicidal thoughts or attempts.
I have been diagnosed with a psychogenic movement disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

In-clinic Study Phase

Short-term administration of aDBS with different pipeline-suggested settings assessed for clinical efficacy and safety

Several hours per session, repeated as needed
Multiple sessions (in-person)

At-home Study Phase

Long-term administration of aDBS during awake hours, with periodic adjustments based on subjective and objective reports

40-60 days
Daily monitoring (remote)

Randomized, Blinded Clinical Trial

Comparison of aDBS and cDBS in counterbalanced blocks, with patients alternating between treatments

1-7 day blocks over 40-60 days
Alternating treatments (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Medtronic Percept Deep Brain Stimulation (adaptive DBS)
  • Medtronic Percept Deep Brain Stimulation (cDBS)

Trial Overview

The study compares two types of deep brain stimulation: traditional constant DBS (cDBS) versus adaptive DBS (aDBS), which automatically adjusts settings based on real-time brain signals, using an automated system to optimize the parameters.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Data-driven adaptive DBS programmingExperimental Treatment2 Interventions
Group II: Open-loop continuous deep brain stimulationActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Citations

Adaptive DBS: A New Era in Parkinson's Disease Treatment

The therapy can dramatically improve tremors, stiffness, and slow movements – and allow for reductions in medication dosage.

BrainSense™ Technology

See what preference is clear 98% of patients with Parkinson's disease preferred BrainSenseTM aDBS over traditional DBS after using for 30 days.¶

Groundbreaking study published in the Journal of ...

Findings show that aDBS is safe, well tolerated, and can provide an effective therapy compared to continuous DBS (cDBS).2

Sensing data and methodology from the Adaptive DBS ... - PMC

The ADAPT-PD trial sensing data indicate a high LFP signal presence in both on and off medication states of these patients, with bilateral ...

Long-Term Personalized Adaptive Deep Brain Stimulation ...

Long-term aDBS provided tolerable, effective, and safe therapy in persons with Parkinson disease whose symptoms were previously stable while ...