Pairing Subjective Patient Rating and DBS Programming
ConditionParkinson's Disease (PD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age35-80
SponsorLudwig-Maximilians - University of Munich
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
The study population consists of adult patients with idiopathic Parkinson's disease treated with bilateral subthalamic nucleus deep brain stimulation (STN-DBS). Participants are recruited from specialized DBS centers during postoperative follow-up or ambulatory care. All patients are capable of providing informed consent and participating in standardized clinical, electrophysiological, and patient-reported assessments. The cohort includes individuals implanted with DBS systems that allow recording of local field potentials, enabling analysis of electrophysiological biomarkers in relation to subjective patient-reported DBS efficacy and neuroimaging data.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention (observational study)
Other interventionNo intervention (observational study)
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Parkinson's disease patients with STN-DBS (PERCEPT-DBS cohort)1 intervention
Trial outcomes
Primary outcomes
1
Correlation between beta-band local field potentials and patient-reported DBS efficacy
The primary outcome is the relationship between electrophysiological activity recorded from the subthalamic nucleus and subjective patient assessment of deep brain stimulation (DBS) efficacy. Beta-band (13-30 Hz) local field potential (LFP) amplitude recorded from implanted DBS electrodes is correlated with patient-reported ratings of overall stimulation quality measured using a visual analogue scale (VAS) during blinded monopolar programming. Outcome analyses assess whether electrophysiological markers correspond to higher subjective DBS benefit and whether overlapping signals define individualized stimulation "sweet spots."
Time frame
30 to 45 days after DBS electrode implantation (first study visit)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ludwig-Maximilians - University of Munich
Lead sponsor
Medtronic
Collaborator
Source ClinicalTrials.gov