Deep Brain Stimulation Clinical Trials

Clinical trials related to Deep Brain Stimulation Procedure

Optimizing Adaptive Deep Brain Stimulation for Parkinson's Disease

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
UC Davis Center for Neuroscience
RECRUITING
Davis
Contact Information
Primary
Annie K Abay, B.S.
akabay@health.ucdavis.edu
408-728-0148
Time Frame
Start Date: 2026-05-08
Estimated Completion Date: 2032-07-01
Participants
Target number of participants: 35
Treatments
Experimental: aDBS-Extended
Adaptive DBS 1 - Extended (aDBS-Extended): neural signal biomarkers and thresholds established through an extended optimization protocol that integrates in-clinic and at-home recordings across multiple medication states. Participants receive this condition for 1 week per block, repeated 8 times over \~6 months in randomized crossover with the other two conditions.
Active_comparator: aDBS-Standard
Adaptive DBS 2 - Standard (aDBS-Standard): neural signal biomarkers and thresholds optimized during short, limited programming sessions, consistent with Medtronic's recommended clinical procedure. Participants receive this condition for 1 week per block, repeated 8 times over \~6 months in randomized crossover with the other two conditions.
Active_comparator: Continuous DBS (cDBS) - Active Control
Continuous DBS (cDBS, active control): constant amplitude at the participant's stable clinical setting. Biomarker and frequency band parameters will be recorded but will not modulate stimulation. Participants receive this condition for 1 week per block, repeated 8 times over \~6 months in randomized crossover with the other two conditions.
Sponsors
Leads: University of California, Davis

This content was sourced from clinicaltrials.gov