Pairing Subjective Patient Rating and DBS Programming
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention (observational study).
- Who it may be relevant to
- Registry conditions: Parkinson's Disease (PD). Basic parameters: 35 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pairing Subjective Patient Rating and Local Field Potentials for DBS Programming
Overview
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.
Interventions
- Other No intervention (observational study)
No intervention (observational study)
Primary outcome measures
- Correlation between beta-band local field potentials and patient-reported DBS efficacy [Time frame: 30 to 45 days after DBS electrode implantation (first study visit)]
Eligibility criteria
Inclusion criteria
Age between 35 and 80 years
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
Any condition impairing the ability to provide informed consent or comply with study procedures
Presence of exclusion criteria for Parkinson's disease according to MDS criteria
Manifest dementia according to ICD-10 criteria
Severe neurological, psychiatric, or medical conditions interfering with study participation or assessments
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- LMU University Hospital — München
Identifiers
NCT: NCT07336199 · PERCEPT-DBS STUDY