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NCT Number: NCT07336199

Pairing Subjective Patient Rating and 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.

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Key information

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

LMU University Hospital

München, 81377, Germany

Location status: Recruiting

Location contact

PD Dr. med. Thomas Köglsperger, MHBA

CONTACT

[email protected]

089440046433

Who can participate

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

Treatment and study plan

No intervention (observational study)

Other

No intervention (observational study)

Primary outcomes

  1. 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."

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas Köglsperger, PD Dr. med., MHBA

CONTACT

[email protected]

+4989440073901

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • Medtronic

Registry information

Official study title

Pairing Subjective Patient Rating and Local Field Potentials for DBS Programming

Acronym: PERCEPT-DBS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
Jan 14, 2026

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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