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Optimizing Adaptive DBS for Parkinson's Disease

Optimizing Adaptive Deep Brain Stimulation for Parkinson's Disease

Who can join

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

Age
18 Years and older
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

Not stated in the study description — ask the study team about visits and procedures.

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 whether brain recordings taken during daily life can improve deep brain stimulation (DBS), a treatment that sends electrical signals to the brain. It compares steady DBS with two ways of setting DBS that adjusts to brain activity. It is for adults with Parkinson’s disease who already have certain DBS devices and whose movement symptoms change with medication.

Parkinson's disease (PD) affects more than 10 million people worldwide and causes progressive motor symptoms such as slowness, stiffness and tremor. For patients whose symptoms are no longer adequately controlled with medication, deep brain stimulation (DBS) can substantially improve motor function. More recently, adaptive DBS (aDBS) has become available. Unlike conventional DBS, which delivers continuous stimulation, aDBS automatically adjusts stimulation in response to brain activity recorded by the implanted device. Current clinical aDBS programming is based primarily on brief recordings obtained during clinic visits. However, Parkinson's symptoms and the underlying brain signals change throughout the day in response to medication, daily activities and other factors. As a result, recordings collected during a single clinic visit may not fully capture the neural activity that best reflects a patient's symptoms in everyday life. The purpose of this study is to determine whether incorporating long-term brain recordings collected during daily life improves adaptive DBS programming and clinical outcomes. Participants will first undergo in-clinic testing to identify brain signals associated with their symptoms. Brain activity and symptoms will then be monitored during everyday life using the sensing capabilities of the implanted DBS device. Participants with suitable brain signals will enter a randomized, blinded crossover study comparing three stimulation approaches: conventional continuous DBS, adaptive DBS programmed using the current clinic-based approach and adaptive DBS programmed using both clinic and at-home recordings. The study will compare the effects of these approaches on motor fluctuations and quality of life. It will also determine how frequently different brain signals occur in people with Parkinson's disease and how well they reflect motor symptoms, providing information that may improve future adaptive DBS therapies.

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

Eligibility

Who can join

  • Age 18 or older, with a diagnosis of Parkinson’s disease of unknown cause that meets standard medical guidelines.
  • Movement symptoms change as medication takes effect or wears off.
  • Have a commercially available DBS device that records brain activity and treats both sides of a brain area called the subthalamic nucleus (STN).
  • Steady DBS settings have not changed for at least 3 months.
  • Parkinson’s medicines have not changed for at least 4 weeks.
  • Can understand the study and agree to take part, and can speak and understand English well enough to participate without an interpreter.
  • Able and willing to complete study visits and monitoring at home.
  • For Part 2, screening must show a brain signal from the STN that is suitable for setting the treatment.

Who can't join

  • Have another disorder that causes Parkinson’s-like symptoms, or have had brain surgery other than STN DBS.
  • Have major thinking or memory problems, dementia, a thinking-test score below the study’s cutoff, or cannot understand and agree to take part.
  • Have an active mental health condition that could make participation unsafe or difficult, such as uncontrolled depression, psychosis, or severe anxiety.
  • Have had suicidal thoughts, suicidal behavior, or a suicide attempt within the past year.
  • Have an unstable health condition that raises study risks, such as uncontrolled high blood pressure or advanced heart or lung disease.
  • Currently misuse or depend on alcohol or drugs.
  • Are in another treatment study that could affect the results, are pregnant, or plan to become pregnant during the study.
  • Cannot or will not follow study steps, including home monitoring, visits, and data collection.

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

Official eligibility criteria

Inclusion Criteria: * Subjects will be 18 and over * Clinical diagnosis of idiopathic Parkinson's disease (PD), consistent with MDS diagnostic criteria * Motor fluctuations in response to medication * Bilateral subthalamic nucleus (STN) DBS using a commercial sensing-enabled device * Stable cDBS settings for ≥3 months prior to enrollment * Stable antiparkinsonian medication regimen for ≥4 weeks prior to enrollment * Capacity to provide informed consent * Ability and willingness to complete study visits and at-home monitoring * For Part 2: Presence of an adequate STN neural signal (e.g., stable LFP feature suitable for biomarker extraction) during screening * Ability to speak and understand English sufficiently to provide informed consent and complete study procedures and assessments without an interpreter. Exclusion Criteria: * Atypical or secondary parkinsonism (e.g., multiple system atrophy, progressive supranuclear palsy, vascular parkinsonism) * Prior brain surgery other than STN DBS * Clinically significant cognitive impairment or dementia, defined as MoCA \< 24 or equivalent, or lacking capacity to provide informed consent * Active psychiatric illness that could compromise safety or participation (e.g., uncontrolled depression, psychosis, severe anxiety disorder) * History of suicidality or suicide attempt within the past year * Clinically unstable medical conditions (e.g., uncontrolled hypertension, advanced cardiac or pulmonary disease) that would increase study risk * Current substance abuse or dependence * Ongoing participation in another interventional trial that could confound outcomes * Pregnancy or plans to become pregnant during the study period * Inability or unwillingness to comply with study procedures (e.g., at-home monitoring, study visits, data collection)

Study sites (1)

CA