LMU University Hospital
München, 81377, Germany
Location status: Recruiting
NCT Number: NCT07336199
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.
Interested in participating?
Request Info35 year–80 year
All sexes
Observational
München, 81377, Germany
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
No intervention (observational study)
Time frame: 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."
Contact information is provided by the study sponsor or research team.
Ludwig-Maximilians - University of Munich
Other
Pairing Subjective Patient Rating and Local Field Potentials for DBS Programming
Acronym: PERCEPT-DBS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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