RecruitingNCT07336199

Pairing Subjective Patient Rating and DBS Programming

Pairing Subjective Patient Rating and Local Field Potentials for DBS Programming


Sponsor

Ludwig-Maximilians - University of Munich

Enrollment

25 participants

Start Date

Dec 2, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This multicenter, prospective and retrospective diagnostic study investigates personalized programming strategies for deep brain stimulation (DBS) in patients with Parkinson's disease. DBS of the subthalamic nucleus (STN) is an established therapy for advanced Parkinson's disease; however, optimization of stimulation parameters remains time-consuming and resource-intensive due to the growing complexity of electrode designs and programming options. The PERCEPT-DBS study aims to improve DBS programming by combining subjective patient-reported outcomes with objective electrophysiological biomarkers. Specifically, the study examines the relationship between patients' subjective assessment of stimulation efficacy, measured using a visual analogue scale (VAS), and local field potentials (LFPs), with a focus on beta-band activity recorded from implanted DBS electrodes. These data are integrated with structural and functional neuroimaging to identify individualized stimulation "sweet spots" within the STN. A total of 24 patients with idiopathic Parkinson's disease treated with bilateral STN-DBS will be recruited across several German DBS centers. Participants undergo standardized clinical assessments, VAS-based blinded monopolar reviews, and LFP recordings using sensing-enabled implantable pulse generators. In addition, imaging-based analyses are performed to relate electrophysiological and subjective measures to anatomical and connectomic features. The primary objective is to determine whether electrophysiological markers correlate with subjective patient ratings and whether their overlap defines personalized optimal stimulation targets. By integrating patient perception with neurophysiological and imaging data, this study seeks to advance individualized DBS programming strategies and contribute to the development of more efficient, patient-centered, and potentially adaptive DBS therapies.


Eligibility

Min Age: 35 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how to better program deep brain stimulation (DBS) devices in people with Parkinson's disease by pairing the patient's own real-time ratings of how they feel with measurements of brain activity recorded by the DBS device. The goal is to optimize stimulation settings more precisely. **You may be eligible if...** - You are between 35 and 80 years old - You have been diagnosed with idiopathic Parkinson's disease (the most common form) - You have already had bilateral deep brain stimulation (DBS) implanted in the subthalamic nucleus - Your DBS device is capable of recording brain electrical signals - You are able to understand the study procedures and communicate reliably **You may NOT be eligible if...** - You have been diagnosed with dementia - You have other serious neurological, psychiatric, or medical conditions that affect your ability to participate - Your Parkinson's diagnosis does not meet the standard diagnostic criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo intervention (observational study)

No intervention (observational study)


Locations(1)

LMU University Hospital

München, Germany

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NCT07336199


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