NCT07336199 Pairing Subjective Patient Rating and DBS Programming
| NCT ID | NCT07336199 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ludwig-Maximilians - University of Munich |
| Condition | Parkinson's Disease (PD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-12-02 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2024-12-02 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07336199 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 80 Years, studying Parkinson's Disease (PD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07336199 currently recruiting?
Yes, NCT07336199 is actively recruiting participants. Contact the research team at thomas.koeglsperger@med.uni-muenchen.de for enrollment information.
Where is the NCT07336199 trial being conducted?
This trial is being conducted at München, Germany.
Who is sponsoring the NCT07336199 clinical trial?
NCT07336199 is sponsored by Ludwig-Maximilians - University of Munich. The trial plans to enroll 25 participants.
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