Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
25 participants
OBSERVATIONAL
2024-12-02
2026-10-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Parkinson's disease patients with STN-DBS (PERCEPT-DBS cohort)
Patients with idiopathic Parkinson's disease who have undergone bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN). Participants are implanted with sensing-enabled implantable pulse generators (e.g., Medtronic Percept™) and undergo standardized DBS programming assessments. The intervention of interest includes DBS parameter testing combined with recording of local field potentials (LFPs) and patient-reported subjective ratings using a visual analogue scale (VAS). Clinical assessments and neuroimaging data are integrated to identify personalized stimulation "sweet spots" and to evaluate the relationship between subjective symptom improvement and electrophysiological biomarkers.
No intervention (observational study)
No intervention (observational study)
Interventions
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No intervention (observational study)
No intervention (observational study)
Eligibility Criteria
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Inclusion Criteria
Clinically confirmed idiopathic Parkinson's disease according to Movement Disorder Society (MDS) criteria
Status post bilateral deep brain stimulation of the subthalamic nucleus (STN-DBS)
Implanted DBS system suitable for electrophysiological recordings (prospective cohort: sensing-enabled IPG)
Ability to understand study procedures and communicate reliably with the investigator
Written informed consent provided
Exclusion Criteria
Manifest dementia according to ICD-10 criteria
Severe neurological, psychiatric, or medical conditions interfering with study participation or assessments
35 Years
80 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Ludwig-Maximilians - University of Munich
OTHER
Responsible Party
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Thomas Köglsperger
Principal Investigator
Locations
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LMU University Hospital
München, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PERCEPT-DBS STUDY
Identifier Type: -
Identifier Source: org_study_id
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