Pairing Subjective Patient Rating and DBS Programming (PERCEPT-DBS)

January 12, 2026 updated by: Thomas Köglsperger, Ludwig-Maximilians - University of Munich

Pairing Subjective Patient Rating and Local Field Potentials for DBS Programming

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
No intervention (observational study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Estimated)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PERCEPT-DBS STUDY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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