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

NCT07682311 | Recruiting DMC FDA Device

• 1 other identifier: 25-45350
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PD - Parkinson's Disease

Keywords

DBS; adaptive; aDBS; adaptive deep brain stimulation; Medtronic Percept; Parkinson's Disease; PD; Percept

Outcome Measures

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.

  Through study completion, an average of 1 year.

Secondary Outcomes (2)

• Changes in Quality of Life

  Through study completion, an average of 1 year.

• Change in Total Electrical Energy Delivered (TEED)

  Through study completion, an average of 1 year.

Study Arms (2)

Data-driven adaptive DBS programming

EXPERIMENTAL

Patients receive adaptive deep brain stimulation delivered through the Medtronic Percept PC/RC device, programmed with control parameters (sensing channel, detection thresholds, ramp rates, stimulation amplitude limits) recommended by the data-driven optimization pipeline and reviewed by a clinical researcher before programming. Stimulation amplitude is automatically adjusted between predefined upper and lower limits in response to sensed beta-band neural activity. Applied in counterbalanced 1-7 day blocks during awake hours in Session 6. These blocks will be randomized and counterbalanced for 40-60 days in patients' homes. Patients will be in cDBS mode overnight and will perform a blinded switch to either cDBS or aDBS upon waking in the morning.

Device: Medtronic Percept Deep Brain Stimulation (adaptive DBS); Device: Medtronic Percept Deep Brain Stimulation (cDBS)

Open-loop continuous deep brain stimulation

ACTIVE COMPARATOR

Participants with Parkinson's disease implanted with Percept and receiving open-loop deep brain stimulation.

Device: Medtronic Percept Deep Brain Stimulation (adaptive DBS); Device: Medtronic Percept Deep Brain Stimulation (cDBS)

Interventions

Medtronic Percept Deep Brain Stimulation (cDBS) DEVICE

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

Also known as: deep brain stimulation, cDBS, continuous DBS, clinical DBS, continuous deep brain stimulation

Data-driven adaptive DBS programming; Open-loop continuous deep brain stimulation

Medtronic Percept Deep Brain Stimulation (adaptive DBS) DEVICE

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

Also known as: aDBS, adaptive DBS, adaptive deep brain stimulation

Data-driven adaptive DBS programming; Open-loop continuous deep brain stimulation

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)).
• Signed informed consent.
• Ability to comply with study follow-up visits for brain recording, testing of adaptive stimulation, and clinical assessment.
• 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.
• Has available cDBS Timeline LFP and stimulation data lasting at least 1 day.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94107, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Simon Little, MBBS,PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Coordinator

CONTACT

5175152739; sebastian.liu@ucsf.edu

Research Manager

CONTACT

sarah.wang@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Clinical Neurology

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: July 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2032
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)