Parkinson's DiseaseNCT03982953
Predicting Cognition After DBS for Parkinson's Disease
An observational study of Parkinson's Disease and Deep Brain Stimulation, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim of the study is to improve estimation of cognitive outcome after STN-DBS in PD in order to avoid risk factors by optimizing peri- and intraoperative management personalize therapeutic strategies for optimal long-term benefit The investigators will test possible predictors (clinical, neuropsychological… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson's Disease, Deep Brain Stimulation, Postoperativeneurocognitive Deficit
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 12 Jun 2019to 10 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PD patients that are planned to undergo STN-DBS. Possible contraindications to DBS are tested according to clinic-intern standard operation procedures. Tests include * Clinical scales: DemTect, MMST, ADL, MDS-UPDRS I-IV including video documentation of MDS-UPDRS III on and off dopaminergic medication * Questionnaires: expectations regarding DBS, PDQ39, BDI, Starkstein-Apathie-Skala, QUIP(-RS) * General examinations: Routine laboratory, ECG, TTE, Chest X-Ray, lung function, 24h-RR, Duplex sonography of extracranial arteries * Expert opinion from related fields: Neuropsychological exam, psychiatric examination, neurosurgery and anesthisiologic consultation
Who may be able to join
- Diagnosis of idiopathic Parkinson's Disease
- Indication for STN-DBS
Who cannot join
- Internistic, surgical or psychiatric contrainidications with respect to the DBS operation or treatment for the STN-DBS group
- Dementia
- Relevant language barrier
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 13351
Dorothee Kübler, MD, +4930450660528, dorothee.kuebler@charite.de
Lucia K Feldmann, MD, +4930450660298
About this study
Official title: Predictors of Cognitive Change After Deep Brain Stimulation in the Subthalmic Nucleus in Parkinson's Disease
The aim of the study is to improve estimation of cognitive outcome after STN-DBS in PD in order to
- avoid risk factors by optimizing peri- and intraoperative management
- personalize therapeutic strategies for optimal long-term benefit
The investigators will test possible predictors (clinical, neuropsychological, neuroimaging, electrophysiological and molecular) for the risk of cognitive dysfunction after deep brain stimulation of the subthalamic nucleus (STN-DBS) in Parkinson's disease (PD) at a single center (Charité - Universitätsmedizin Berlin, Germany). Data collection takes place prior to as well as 3 and 12 months after the STN-DBS operation. Participation is proposed to all PD patients that are planned to undergo STN-DBS after careful examination of eligibility for this treatment according to standard operation procedures.
Read the detailed description
Additionally to clinical routine tests, we will investigate the following possible predictors of cognitive dysfunction after STN-DBS in PD:
- Imaging biomarkers: volume of the nucleus basalis of Meynert (NBM) measured on preoperative MRI and data driven search for unknown MRI characteristics relating to the incidence of postoperative neurocognitive disorder by means of Deep Learning (Convolutional Neural Networks), test of previously established classification models
- Molecular biomarkers in CSF: TAU, phospho-TAU, ß-Amyloid 1-40 and 1-42 as well as NFL measured preoperatively
- Comorbidity: according to the Charlson Comorbidity Index
- Nutritional Status: defined by the Mini Nutritional Assessment (MNA-SF)
- Duration of intra-/perioperative brake of dopaminergic medication
- Nature and depth of anaesthesia: general or conscious sedation and depth of consciousness: as measured by 4 channel electroencephalography (SedLine®) and during implantation of impulse generator
- Incidence and duration of postoperative delirium: defined according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and/or as ≥ 2 points in the nursing Delirium Screening Scale (Nu-DESC) and/or a positive Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score, assessment three times daily during hospital stay
- Length of stay at ICU / hospital
- Postoperative organ complications: according to Clavien-Dindo classification
- Localisation of bilateral electrodes and active contacts on postoperative imaging
Substudies
Correlation of domain specific CANTAB connect test scores with possible predictors and incidence of postoperative neurocognitive disorder
Social Cognition: comparison of pre- and postoperative Theory of Mind (ToM) abilities measured by the Yoni-Paradigma (assesses affective and cognitive ToM)
The resulting multivariate risk model is expected
- to improve peri- and intraoperative management by identifying avoidable risk factors for the development of postoperative cognitive deficit
- to support evidence-based and personalized decision-making when advising PD patients considering STN-DBS
- to result in the development of future hypothesis-driven interventional trials on the basis of biomarker-based sub-grouping of patients
- to allow a better understanding of underlying pathophysiological processes both PD and surgery-related regarding cognitive effects of STN-DBS
- Conditions
- Parkinson's Disease, Deep Brain Stimulation, Postoperativeneurocognitive Deficit, Postoperative Delirium
- Medical subject headings
- Parkinson Disease, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PD patients with STN-DBS | Patients with the diagnosis of Levodopa responsive idiopathic Parkinson's Disease that are planned to undergo craniectomy with implantation of bilateral DBS electrodes in the subthalamic nucleus | |
| Controls - PD patients with medical treatment | Patients with the diagnosis of Levodopa responsive idiopathic Parkinson's Disease that do not undergo DBS for personal reasons or contraindications for this treatment. Age, sex and disease-severity matched with PD patients with STN-DBS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive performance after STN-DBS
Based on cognitive screening by paper pencil test (MoCA)
Measured: Difference between pre- and 12 months postoperative testing
Incidence of postoperative neurocognitive disorder
- According to DSM-5 criteria applying the tablet-based neuropsychological test battery Cambridge Neuropsychological Test Automated Battery (CANTAB connect)
Measured: Difference between pre- and 3 and 12 months postoperative testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start12 Jun 2019
- Primary completion10 Jun 2022 (estimated)
- Study completion10 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorothee Kübler, Charite University, Berlin, Germany
- Investigators
- Andrea A Kühn, Prof. MD, Study director, Neurology, Head of the Movement Disorders and Neuromodulation Section
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982953
- Sponsor's protocol ID
- EA2/040/19
- Status last verified
- May 2021
- First submitted
- 9 Jun 2019
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kubler-Weller D, Stuke H, Astalosch M, Martins Ribeiro L, Landfried E, Schneider GH, Faust K, Krause P, Roediger J, Haufe S, Mousavi M, Al-Fatly B, Spies C, Borchers F, Kuhn AA. Predicting cognition after subthalamic Deep Brain Stimulation in Parkinson's Disease. NPJ Parkinsons Dis. 2025 Aug 28;11(1):265. doi: 10.1038/s41531-025-01128-3.
PubMed 40877314
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Cognitive Change After Deep Brain Stimulation in the Subthalmic Nucleus in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03982953
- Acronym / sponsor ID
- EA2/040/19
- Conditions
- Parkinson's Disease, Deep Brain Stimulation, Postoperativeneurocognitive Deficit, Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 10 Jun 2022 (estimated)
- Study completion
- 10 Aug 2022 (estimated)
- First posted
- 12 Jun 2019 (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.
The aim of the study is to improve estimation of cognitive outcome after STN-DBS in PD in order to
- avoid risk factors by optimizing peri- and intraoperative management
- personalize therapeutic strategies for optimal long-term benefit
The investigators will test possible predictors (clinical, neuropsychological, neuroimaging, electrophysiological and molecular) for the risk of cognitive dysfunction after deep brain stimulation of the subthalamic nucleus (STN-DBS) in Parkinson's disease (PD) at a single center (Charité - Universitätsmedizin Berlin, Germany). Data collection takes place prior to as well as 3 and 12 months after the STN-DBS operation. Participation is proposed to all PD patients that are planned to undergo STN-DBS after careful examination of eligibility for this treatment according to standard operation procedures.
Detailed description
Additionally to clinical routine tests, we will investigate the following possible predictors of cognitive dysfunction after STN-DBS in PD:
- Imaging biomarkers: volume of the nucleus basalis of Meynert (NBM) measured on preoperative MRI and data driven search for unknown MRI characteristics relating to the incidence of postoperative neurocognitive disorder by means of Deep Learning (Convolutional Neural Networks), test of previously established classification models
- Molecular biomarkers in CSF: TAU, phospho-TAU, ß-Amyloid 1-40 and 1-42 as well as NFL measured preoperatively
- Comorbidity: according to the Charlson Comorbidity Index
- Nutritional Status: defined by the Mini Nutritional Assessment (MNA-SF)
- Duration of intra-/perioperative brake of dopaminergic medication
- Nature and depth of anaesthesia: general or conscious sedation and depth of consciousness: as measured by 4 channel electroencephalography (SedLine®) and during implantation of impulse generator
- Incidence and duration of postoperative delirium: defined according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and/or as ≥ 2 points in the nursing Delirium Screening Scale (Nu-DESC) and/or a positive Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score, assessment three times daily during hospital stay
- Length of stay at ICU / hospital
- Postoperative organ complications: according to Clavien-Dindo classification
- Localisation of bilateral electrodes and active contacts on postoperative imaging
Substudies
Correlation of domain specific CANTAB connect test scores with possible predictors and incidence of postoperative neurocognitive disorder
Social Cognition: comparison of pre- and postoperative Theory of Mind (ToM) abilities measured by the Yoni-Paradigma (assesses affective and cognitive ToM)
The resulting multivariate risk model is expected
- to improve peri- and intraoperative management by identifying avoidable risk factors for the development of postoperative cognitive deficit
- to support evidence-based and personalized decision-making when advising PD patients considering STN-DBS
- to result in the development of future hypothesis-driven interventional trials on the basis of biomarker-based sub-grouping of patients
- to allow a better understanding of underlying pathophysiological processes both PD and surgery-related regarding cognitive effects of STN-DBS
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD patients with STN-DBS | – | –Patients with the diagnosis of Levodopa responsive idiopathic Parkinson's Disease that are planned to undergo craniectomy with implantation of bilateral DBS electrodes in the subthalamic nucleus |
| Controls - PD patients with medical treatment | – | –Patients with the diagnosis of Levodopa responsive idiopathic Parkinson's Disease that do not undergo DBS for personal reasons or contraindications for this treatment. Age, sex and disease-severity matched with PD patients with STN-DBS. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PD patients that are planned to undergo STN-DBS. Possible contraindications to DBS are tested according to clinic-intern standard operation procedures. Tests include * Clinical scales: DemTect, MMST, ADL, MDS-UPDRS I-IV including video documentation of MDS-UPDRS III on and off dopaminergic medication * Questionnaires: expectations regarding DBS, PDQ39, BDI, Starkstein-Apathie-Skala, QUIP(-RS) * General examinations: Routine laboratory, ECG, TTE, Chest X-Ray, lung function, 24h-RR, Duplex sonography of extracranial arteries * Expert opinion from related fields: Neuropsychological exam, psychiatric examination, neurosurgery and anesthisiologic consultation
Key inclusion criteria (2 listed)
- Diagnosis of idiopathic Parkinson's Disease
- Indication for STN-DBS
Key exclusion criteria (3 listed)
- Internistic, surgical or psychiatric contrainidications with respect to the DBS operation or treatment for the STN-DBS group
- Dementia
- Relevant language barrier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in cognitive performance after STN-DBS
Time frame: Difference between pre- and 12 months postoperative testing
Based on cognitive screening by paper pencil test (MoCA)
Incidence of postoperative neurocognitive disorder
Time frame: Difference between pre- and 3 and 12 months postoperative testing
• According to DSM-5 criteria applying the tablet-based neuropsychological test battery Cambridge Neuropsychological Test Automated Battery (CANTAB connect)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Derived from this study: PubMed 40877314Kubler-Weller D, Stuke H, Astalosch M, Martins Ribeiro L, Landfried E, Schneider GH, Faust K, Krause P, Roediger J, Haufe S, Mousavi M, Al-Fatly B, Spies C, Borchers F, Kuhn AA. Predicting cognition after subthalamic Deep Brain Stimulation in Parkinson's Disease. NPJ Parkinsons Dis. 2025 Aug 28;11(1):265. doi: 10.1038/s41531-025-01128-3.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Andrea A Kühn, Prof. MD study director
Neurology, Head of the Movement Disorders and Neuromodulation Section
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 and Deep Brain Stimulation, run by Charite University, Berlin, Germany 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dorothee Kübler, MD (+4930450660528, dorothee.kuebler@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive performance after STN-DBS (time frame: Difference between pre- and 12 months postoperative testing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03982953, which also lists 1 linked publication.
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 7 May 2021; AzTrials last refreshed its copy on 4 Nov 2026.