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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-75
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 25-75.

Diagnosis of idiopathic PD.

Patient has undergone surgical intervention with deep brain stimulation (Percept device) for their disorder at least 2 months prior to recruitment.

Absence of significant cognitive impairment (score of 24 or greater on the Montreal Cognitive Assessment (MoCA)).

Disqualifiers

Patient meets criteria for a psychogenic movement disorder.

Significant untreated depression (BDI-II score >20). History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS).

Any personality or mood symptoms that study personnel believe will interfere with study requirements.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Medtronic Percept Deep Brain Stimulation (adaptive DBS)

    Device

    Using the Percept pulse generator, patients receive adaptive stimulation to the subthalmaic nucleus.

  • Medtronic Percept Deep Brain Stimulation (cDBS)

    Device

    Using the Percept pulse generator, patients receive clinically-optimized open loop stimulation to the subthalmaic nucleus.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Data-driven adaptive DBS programmingExperimental treatment 2 interventions
Group B: Open-loop continuous deep brain stimulationActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in number of bothersome movement symptoms on data-driven adaptive deep brain stimulation compared to open-loop deep brain stimulation

Troublesome movement symptoms will be detected using validated wearable devices along with participant self-reporting.

Time frame
Through study completion, an average of 1 year.

Secondary outcomes

1

Changes in Quality of Life

Self-reported surveys built in REDCAP to track bothersome symptoms (motor and non-motor). EQ-5D will be administered.

Time frame
Through study completion, an average of 1 year.
2

Change in Total Electrical Energy Delivered (TEED)

Change in TEED calculated using voltage, frequency, pulse width, and impedence values from participant pulse generators, with adaptive compared to open-loop deep brain stimulation (DBS). TEED is measured in microjoules. Percentage of time in high and low adaptive stimulation states and average consecutive stimulation amplitude.

Time frame
Through study completion, an average of 1 year.

Other outcomes

Sponsors and contacts

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