Parkinson's Disease (PD)PERCEPT-DBSNCT07336199
Pairing Subjective Patient Rating and DBS Programming
An observational study of Parkinson's Disease (PD), run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
This multicenter, prospective and retrospective diagnostic study investigates personalized programming strategies for deep brain stimulation (DBS) in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Parkinson's Disease (PD)
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 2 Dec 2024to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
LMU University Hospital
München, 81377
PD Dr. med. Thomas Köglsperger, MHBA, 089440046433, thomas.koeglsperger@med.uni-muenchen.de
About this study
Official title: 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.
Read more
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)
- Being tested
- No intervention (observational study)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
No intervention (observational study)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 30 to 45 days after DBS electrode implantation (first study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start2 Dec 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Thomas Köglsperger, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336199
- Sponsor's protocol ID
- PERCEPT-DBS STUDY
- Acronym
- PERCEPT-DBS
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pairing Subjective Patient Rating and Local Field Potentials for DBS Programming
- ClinicalTrials.gov ID
- NCT07336199
- Acronym / sponsor ID
- PERCEPT-DBS / PERCEPT-DBS STUDY
- Conditions
- Parkinson's Disease (PD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease patients with STN-DBS (PERCEPT-DBS cohort) | – | Other: No intervention (observational study)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. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (observational study)No intervention (observational study) | Other | Parkinson's disease patients with STN-DBS (PERCEPT-DBS cohort) |
Primary outcome
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."
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease (PD), run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Köglsperger, PD Dr. med., MHBA (+4989440073901, thomas.koeglsperger@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.