Pairing Subjective Patient Rating and DBS Programming

NCT07336199 | Recruiting FDA Device

• 1 other identifier: PERCEPT-DBS STUDY
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson's Disease (PD)

Outcome Measures

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."

  30 to 45 days after DBS electrode implantation (first study visit)

Study Arms (1)

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.

Other: No intervention (observational study)

Interventions

No intervention (observational study) OTHER

No intervention (observational study)

Parkinson's disease patients with STN-DBS (PERCEPT-DBS cohort)

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Any condition impairing the ability to provide informed consent or comply with study procedures
• Manifest dementia according to ICD-10 criteria
• Severe neurological, psychiatric, or medical conditions interfering with study participation or assessments

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• Medtronic: collaborator

Study Sites (1)

LMU University Hospital

München, 81377, Germany

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Observation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Thomas Köglsperger, PD Dr. med., MHBA

CONTACT

+4989440073901; thomas.koeglsperger@med.uni-muenchen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 13, 2026
• Study Start: December 2, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)