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Automated Daytime Adaptive Deep Brain Stimulation Parameter Optimization in Patients Implanted With Percept Neurostimulator

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
25 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year
  • Procedures mentioned: Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients were first clinically optimized in cDBS by a movement disorders neurologist for up to 1 year."
  • "Other risks include increased battery drain due to neural data recording and stimulation adapting, and skin irritation due to using wearable monitors to track severity of PD symptoms."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests an automated method to suggest settings for adaptive deep brain stimulation (DBS). Adaptive DBS uses brain signals to adjust electrical stimulation as needs change. The study is for adults with Parkinson’s disease who have a Percept device and still have changing movement symptoms with constant DBS.

Parkinson's disease (PD) affects \~1% of people over 60 years old, is highly disabling and represents a large economic burden. While dopaminergic medications effectively treat motor symptoms early in the disease, most patients develop complications, including motor fluctuations and dyskinesias, which can be partially managed by deep brain stimulation (DBS). This surgical therapy consists of delivering continuous electrical stimulation through electrodes permanently implanted in basal ganglia nuclei, with a pulse generator and battery unit implanted in the chest. However, conventional DBS therapy is delivered with constant stimulation parameters, referred to as constant deep brain stimulation (cDBS), that are unresponsive to patient activities or to variations in the severity of symptoms during daily life. This leaves many patients under- or over-stimulated during parts of the day. To address the shortcomings of cDBS, adaptive DBS (aDBS) uses real-time detection of neural signals to automatically adjust stimulation amplitude or other parameters in response to patients' dynamic clinical needs. aDBS was approved by the U.S. Food and Drugs Administration (FDA) for clinical treatment of PD in the Percept PC and RC (Medtronic) device in February 2025. Fully leveraging this therapy in the real world is limited by technical challenges, in particular the fact that: while the investigators developed a consistent pipeline for implementing aDBS, there were several critical control parameters that strongly influenced algorithm performance and required prolonged trial-and-error based testing, to achieve successful control. In this new study, the investigators seek to significantly extend this work and address the major barriers to widespread, easy adoption of aDBS by groups without specialized knowledge of neurophysiology or feedback control. Here the investigators aim to test an automated, data-driven pipeline for the recommendation of the adaptive control parameters.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 25–75 years old and have idiopathic Parkinson’s disease, meaning its cause is unknown.
  • Had surgery to place a Percept DBS device at least 2 months before joining.
  • Have no major thinking or memory problems, with a score of at least 24 on the Montreal Cognitive Assessment (MoCA).
  • Sign the form agreeing to take part in the study.
  • Can attend follow-up visits for brain recordings, adaptive stimulation tests, and health checks.
  • Have used constant DBS for at least 2 months but still have major ups and downs in movement symptoms. You must be using adaptive DBS or have been advised to use it as part of your care.
  • Have at least 1 day of stored brain-signal and stimulation data from constant DBS.
  • For the clinical trial phase, agree to return to your usual constant DBS settings for all required constant DBS tests.

Who can't join

  • Have a psychogenic movement disorder, meaning movement symptoms linked to mental or emotional factors.
  • Have significant untreated depression, with a score above 20 on the BDI-II depression test.
  • Have ever attempted suicide or have current suicidal thoughts, shown by a “yes” to questions 2–5 on the C-SSRS suicide screening tool.
  • Have personality or mood symptoms that the study team believes would make it hard to meet study requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Age 25-75. 2. Diagnosis of idiopathic PD. 3. Patient has undergone surgical intervention with deep brain stimulation (Percept device) for their disorder at least 2 months prior to recruitment. 4. Absence of significant cognitive impairment (score of 24 or greater on the Montreal Cognitive Assessment (MoCA)). 5. Signed informed consent. 6. Ability to comply with study follow-up visits for brain recording, testing of adaptive stimulation, and clinical assessment. 7. Patient has been on cDBS for at least two months and still experiences significant residual motor fluctuation while on cDBS. Consequently, patient is undergoing aDBS treatment currently or was recommended aDBS as part of clinical care to manage their residual motor fluctuation. 8. Has available cDBS Timeline LFP and stimulation data lasting at least 1 day. 9. To be enrolled in the clinical trial phase of the study, patient will need to consent to reverting back to their baseline cDBS settings for all required cDBS testings. Exclusion Criteria: 1. Patient meets criteria for a psychogenic movement disorder. 2. Significant untreated depression (BDI-II score \>20). History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS). 3. Any personality or mood symptoms that study personnel believe will interfere with study requirements.

Study sites (1)

CA