Using patient-reported ratings to guide DBS programming
Official title: Pairing Subjective Patient Rating and Local Field Potentials for DBS Programming
Run by Ludwig-Maximilians - University of Munich · NCT07336199 · Data updated 2026-11-12
This project tests whether combining patients' own ratings with brain signal recordings can help find better DBS settings for people with Parkinson's who already have STN-DBS implants.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 35 Years to 80 Years |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Ludwig-Maximilians - University of Munich Academic / other |
| Locations | 1 site (München) |
| Status | Recruiting |
| Started | December 2, 2024 |
| Main results expected | July 1, 2026 |
| Study ends | October 1, 2026 |
| Registry record updated | January 14, 2026 |
| Trial ID | NCT07336199 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 35–80 with clinically confirmed idiopathic Parkinson's disease who have bilateral STN-DBS implants and can communicate reliably, preferably with a sensing-enabled IPG for the prospective cohort.
✕Probably not a fit
Patients without compatible sensing-capable DBS systems, those with manifest dementia, severe comorbid medical or psychiatric conditions, or non-idiopathic Parkinsonism are unlikely to benefit from the findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter prospective and retrospective diagnostic study pairs patients' subjective visual analogue scale (VAS) ratings of stimulation effectiveness with objective local field potential (LFP) recordings, focusing on beta-band activity from implanted STN-DBS electrodes. Structural and functional neuroimaging are integrated to map individualized stimulation "sweet spots" and relate them to electrophysiological signals. The prospective cohort enrolls patients with sensing-enabled implanted pulse generators while retrospective data include recordings from compatible systems. The study is observational and aims to identify markers that could streamline and personalize DBS programming without changing clinical treatment.
Why it matters
Potential benefit: If successful, this approach could speed up DBS programming and personalize stimulation settings to improve symptom control while reducing clinic time and trial-and-error adjustments.
How similar studies have gone: Previous work has shown correlations between STN beta-band LFPs and motor symptoms and has supported sensing-enabled adaptive DBS, but combining patient VAS ratings with imaging-guided 'sweet spot' mapping for programming remains relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
LMU University Hospital
München, Germany Recruiting
Study contacts
- Study coordinator: Thomas Köglsperger, PD Dr. med., MHBA
- Email: thomas.koeglsperger@med.uni-muenchen.de
- Phone: +4989440073901
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.