Cognitive ImpairmentNCT06272968
Predicting Cognition After DBS for Parkinson's Disease 2
An observational study of Cognitive Impairment, 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 and personalize therapeutic strategies for optimal long-term benefit. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Neuropsychological Testing
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2024to 1 Dec 2030
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PD patients that are planned to undergo STN-DBS.
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.
About this study
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 and 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, 12 and 60 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, the following possible predictors of cognitive dysfunction after STN-DBS in PD are investigated:
- 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
- Imaging neuronal glucose metabolism with [18F]-DG PET
- Comorbidity: according to the Charlson Comorbidity Index
- Nutritional Status: defined by the Mini Nutritional Assessment (MNA-SF)
- Functional assessment of neuronal activity by 64-channel-EEG
- 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 with CANTAB assessments performed with STN-DBS stimulation switched on and off at 12- and 60-month follow-up.
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
- Cognitive Impairment
- Being tested
- Neuropsychological Testing
- Keywords
- Cognitive Impairment, Parkinson's disease, Deep Brain Stimulation, Postoperative Delirium
- Medical subject headings
- Cognitive Dysfunction, Parkinson Disease, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological TestingDiagnostic test
Neuropsychological Testing via Cambridge CANTAB Connect
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 Cambridge CANTAB Connect
Measured: Difference between baseline, 12 and 60 months postoperative testing
Incidence of postoperative neurocognitive disorder
Based on cognitive screening by paper pencil test (MoCA or MDRS)
Measured: Difference between baseline, 12 and 60 months postoperative testing
Secondary outcomes (1)
Validation of post-hoc model from prior study (NCT03982953)
MoCA1yFU = 0.7 × MoCAbaseline + 1.7 × backward spanbaseline - 1, (see https://doi.org/10.1038/s41531-025-01128-3)
Measured: 1 year after DBS surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 Oct 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- 30 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
- Dorothee Kübler-Weller, MD, Study chair, Movement Disorders and Neuromodulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272968
- Sponsor's protocol ID
- EA2/252/23
- Status last verified
- Sep 2026
- First submitted
- 16 Feb 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Cognition After DBS for Parkinson's Disease 2
- ClinicalTrials.gov ID
- NCT06272968
- Acronym / sponsor ID
- EA2/252/23
- Conditions
- Cognitive Impairment
- Keywords
- Cognitive Impairment, Parkinson's disease, Deep Brain Stimulation, Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 22 Feb 2024 (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 and 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, 12 and 60 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, the following possible predictors of cognitive dysfunction after STN-DBS in PD are investigated:
- 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
- Imaging neuronal glucose metabolism with [18F]-DG PET
- Comorbidity: according to the Charlson Comorbidity Index
- Nutritional Status: defined by the Mini Nutritional Assessment (MNA-SF)
- Functional assessment of neuronal activity by 64-channel-EEG
- 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 with CANTAB assessments performed with STN-DBS stimulation switched on and off at 12- and 60-month follow-up.
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
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.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological TestingNeuropsychological Testing via Cambridge CANTAB Connect | Diagnostic test | – |
Primary outcome
Change in cognitive performance after STN-DBS
Time frame: Difference between baseline, 12 and 60 months postoperative testing
Based on cognitive screening by Cambridge CANTAB Connect
Incidence of postoperative neurocognitive disorder
Time frame: Difference between baseline, 12 and 60 months postoperative testing
Based on cognitive screening by paper pencil test (MoCA or MDRS)
1 secondary outcome
Validation of post-hoc model from prior study (NCT03982953)
Time frame: 1 year after DBS surgery
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 3 Sep 2026.
- 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.
Dorothee Kübler-Weller, MD study chair
Movement Disorders and Neuromodulation
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 Cognitive Impairment, 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 baseline, 12 and 60 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?
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 3 Sep 2026.