Pairing Subjective Patient Rating and DBS Programming

Condition(s) studied

Investigational drug(s) / intervention(s)

No intervention (observational study): No intervention (observational study)

Study 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

Primary outcome measure(s)

• Correlation between beta-band local field potentials and patient-reported DBS efficacy — 30 to 45 days after DBS electrode implantation (first study visit)
  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."

Trial sites (1)

More Ludwig-Maximilians - University of Munich trials in Germany

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