Parkinson DiseaseSTEREO-DBSNCT05843084
The STEREO-DBS Study: 7-Tesla MRI Brain Network Analysis for Deep Brain Stimulation
An observational study of Parkinson Disease and Diffusion Magnetic Resonance Imaging, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Rationale: Deep brain stimulation (DBS) of the nucleus subthalamicus (STN) is an effective surgical treatment for the patients with advanced Parkinson's disease, despite optimal pharmacological treatment. However, individual improvement after DBS remains variable and 50% of patients show insufficient benefit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Diffusion Magnetic Resonance Imaging, Brain
- What is being tested?
- 7T MRI network analysis for deep brain stimulation in Parkinson's disease
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Apr 2022to 11 Apr 2033
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: STUDY POPULATION 1.1 Population (base) Patients with advanced Parkinson's disease who underwent DBS electrode placement using 7T MRI network analysis. If the patient is eligible, the physician coordinating the study will inform the patient, hand over written information about the observational study, and subsequently ask the patient to consider participation. If the patient wants to participate, the informed consent form will be signed. Patients will be given as much time as needed to decide whether to participate in the study. Enrollment will be ongoing from April 2023; patients who underwent 7T MRI network analysis based DBS before this date will also be eligible to participate (all DBS patients are registered in the prospective electronic Castor database).
1.2 Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age > 18 years;
- Idiopathic PD who underwent STN DBS
1.3 Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Legally incompetent adults;
- No written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC, location AMC
Amsterdam, North Holland, 11015AZ
Maarten Bot, MD, PhD, 0031621514048, m.bot@amsterdamumc.nl
Richard Schuurman, MD, PhD, professor, 0031626908484, p.r.schuurman@amsterdamumc.nl
About this study
Rationale: Deep brain stimulation (DBS) of the nucleus subthalamicus (STN) is an effective surgical treatment for the patients with advanced Parkinson's disease, despite optimal pharmacological treatment. However, individual improvement after DBS remains variable and 50% of patients show insufficient benefit. To date, DBS-electrode placement and settings in the highly connected STN are based on 1,5-Tesla or 3-Tesla MR-images. These low resolution and solely structural modalities are unable to visualize the multiple brain networks to this small nucleus and prevent electrode activation directed at its cortical projections. By using structural 7-Tesla MRI (7T MRI) connectivity to visualize (malfunctioning) brain networks, DBS-electrode placement and activation can be individualized.
Objective: Primary objective of the study is to determine whether visualisation of cortical projections originating in the STN and the position of the DBS electrode relative to these projections using 7T MRI improves motor symptoms as measured by the disease-specific Unified Parkinson's Disease Rating Scale (UPDRS-III).
Read more
Secondary outcomes are: disease related daily functioning, adverse effects, operation time, quality of life, patient satisfaction with treatment outcome and patient evaluation of treatment burden.
Study design: The study will be a single center prospective observational study.
Study population: Enrollment will be ongoing from April 2022. Intervention (if applicable): No intervention will be applied. Application of 7T MRI for DBS is standard care and outcome scores used will be readily accessible from the already existing advanced electronic DBS database.
Main study parameters/endpoints: The primary outcome measure is the change in motor symptoms as measured by the disease-specific Unified Parkinson's Disease Rating Scale (UPDRS-III). This is measured after 6 months of DBS as part of standard care. The secondary outcome measures are the Amsterdam Linear Disability Score for functional health status, Parkinson's Disease Questionnaire 39, Starkstein apathy scale, patient satisfaction with the treatment, patient evaluation of treatment burden, operating time, hospitalization time, change of tremor medication, side effects and complications.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The proposed observational research project involves treatment options that are standard care in daily practice. The therapies will not be combined with other research products. Participation in this study constitutes negligible risk according to NFU criteria for human research.
Read the detailed description
INTRODUCTION AND RATIONALE
Deep brain stimulation for Parkinson's disease Deep brain stimulation (DBS) is an effective treatment in Parkinson's disease (PD), a debilitating neurological disorder. The effect of DBS relies on the modulation of malfunctioning brain networks by delivering electrical pulses within the subthalamic nucleus, deeply seated in the brainstem and the size of a few millimeters (STN; comparable to the size of a coffee bean). However, individual improvement after DBS remains variable and 50% of patients show insufficient benefit. By using structural 7-Tesla magnetic resonance imaging (7T MRI) connectivity to visualize malfunctioning networks, DBS-electrode placement and activation can be individualized.
Current DBS-electrode placement and settings in the highly connected STN are based on 1.5-Tesla or 3-Tesla MR-images. These low resolution modalities are unable to visualize the multiple brain networks to this small nucleus and prevent electrode activation directed at its cortical projections. Integrated structural (7T MRI) network maps will enable brain network-based and patient-specific DBS, improving motor symptoms and quality of life.
7T MRI brain network analysis Since the 1980s, DBS for PD was targeting the STN, a deep-seated grey matter brain nucleus. Current emphasis in the field of DBS is on neural networks rather than separate nuclei in the brain. Several studies showed PD to arise from pathological network activity in subthalamic-cortical projections. In recent years several DBS groups reported about using MRI connectivity to visualize the subthalamic-cortical projections, in DBS for PD.
The small STN is part of multiple large brain networks. DBS is effective in improving UDPRS and quality of life for PD patients only by modulating its motor network. For improving DBS placement and activation, it is essential to understand the networks and the modulatory effect of stimulation. Thus far, visualization of these networks was limited due to low resolution and the lack of structural connectivity (visualising subthalamic-cortical projections using diffusion weighted MRI and probabilistic connectivity).
The investigators therefore added 7T T2 and diffusion-weighted sequences at the Spinoza Centre and showed that probabilistic subthalamic network analyses (STN segmentation) successfully identifies the area within the STN that has the highest density of connections with the motor network in PD patients. In a recent pilot study the investigators showed the implementation of 7T MRI for STN segmentation is well suited within the existing surgical workflow. By generating a 7-Tesla MRI showing the STN (coloured) motor subdivision, this technique clearly visualized this new DBS target. The retrospective analysis showed for conventional MRI targeting strategies only a minority of DBS electrodes were placed in the motor STN. Moreover, the DBS electrodes that were placed in the motor STN resulted in a significantly higher mean improvement (80% versus 50%, measured by the UPDRS-III score).
Generating the 7T MRI network maps for DBS The STN and its cortical connections will be visualized using 7T T2-weighted and diffusion weighted imaging. Three major projections of the STN will be visualised: projections connecting to primary and supplementary motor cortex (motor), projections to the prefrontal cortex (associative) and projections to the basofrontal cortex (limbic). The location of the electrode (using computed tomography) will be visualised relative to the three segmented subdivisions of the STN.
The 7T MRI network map, generated by combining T2 and diffusion weighted MRI, shows the STN (coloured) subdivisions and their cortical projections. The result will then show in which STN subdivision(s) the DBS-electrode contact is situated and to which cortical area the STN subdivision projects. Clinical test scores of the electrode contact will then be correlated to the network maps. Stimulation parameters based on 7T MRI network maps are used to optimize and predict outcome in terms of beneficial clinical effects (suppression tremor, bradykinesia, rigidity) and side effects (speech, gait, apathy). As all network maps are visualised on MRI, this will readily enable both individual and group analyses (co-registrating maps of multiple patients).
Adverse effects In the 350 7T MR-scans the investigators have performed to date, we rarely encountered non-compatible implants or severe claustrophobia. Every patient undergoes screening with a MRI safety questionnaire and MRI metal detector (preventing taking ferromagnetic materials into the MRI). 7T MRI is a non-invasive technique which causes no pain and, importantly, the electromagnetic fields produce no known tissue damage of any kind. The MR system may make loud tapping, knocking, or other noises at times during the procedure. Earplugs are provided to prevent problems that may be associated with noise generated by the scanner. At all times, the patient will be (visually) monitored and will be able to communicate with the 7T MRI technologist using an intercom system. The patient may (request to) stop the acquisition at any time by using the push button (hold by the patient continuously).
In sum, due to implementation of 7T MRI brain network analysis, it is now possibly to directly visualize the motor part of the STN. In current observational study this technique will be evaluated in a prospective fashion, introducing patient specific brain network-guided DBS for PD with delivering a unique and hitherto unavailable dataset: 7T MRI visualizes the anatomical connections of the STN for each individual DBS electrode contact. Instead of a one-DBS-fits all model, the tailored network analyses enable personalized precision modelling in DBS.
- Conditions
- Parkinson Disease, Diffusion Magnetic Resonance Imaging, Brain, Subthalamic Nucleus, Deep Brain Stimulation, Human
- Being tested
- 7T MRI network analysis for deep brain stimulation in Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7T MRI network analysis for deep brain stimulation in Parkinson's diseaseProcedure or surgery
We hypothesize that the implementation of 7T MRI network analysis can enhance the effectiveness of DBS by improving motor symptoms and quality of life in PD patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's Disease Rating Scale (UPDRS-III)
The amount of decrease in motor symptoms indicated by change in the disease-specific Unified Parkinson's Disease Rating Scale (UPDRS-III) after six months of deep brain stimulation. The UPDRS-III scores are between 7 and 86; higher scores indicating worse (more severe) motor symptoms.
Measured: April 2022 - April 2033
Secondary outcomes (3)
The Amsterdam Linear Disability Score for functional health status
The Amsterdam Linear Disability Score (ALDS) is a generic itembank which measures disability, as expressed by the ability to perform activities of daily living. These scores are linearly transformed into values between 0 and 100. Lower scores indicate more disability.
Measured: April 2022 - April 2033
Parkinson's disease questionnaire-39
The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. It also assesses the impact of Parkinson's on specific dimensions of functioning and wellbeing. The scores are between 0 and 100 (the sum of all 39 items), higher score indicating more health problems.
Measured: April 2022 - April 2033
Starkstein apathy scale
The 14-item Starkstein Apathy Scale (SAS) is used to measure the severity of apathetic symptoms in Parkinson disease. The scores are between 0 and 42. Higher scores indicating worse apathy.
Measured: April 2022 - April 2033
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start11 Apr 2022
- Primary completion11 Apr 2033 (estimated)
- Study completion11 Apr 2033 (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 DiseaseStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maarten Bot, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Maarten Bot, MD PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843084
- Sponsor's protocol ID
- W20_540 # 20.599
- Acronym
- STEREO-DBS
- Status last verified
- Jul 2025
- First submitted
- 11 Apr 2023
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
1. Bloem BR, Okun MS, Klein C. Parkinson's disease. Lancet. Apr 9 2021. 2. Bot M, Schuurman PR, Odekerken VJJ, et al. Deep brain stimulation for Parkinson's disease: defining the optimal location within the subthalamic nucleus. J Neurol Neurosurg Psychiatry. May 2018;89(5):493-498. 3. Mathiopoulou V, Rijks N, Caan MWA, et al. Utilizing 7-Tesla Subthalamic Nucleus Connectivity in Deep Brain Stimulation for Parkinson Disease. Neuromodulation. Feb 22 2022. 4. Schrock LE, Patriat R, Goftari M, et al. 7T MRI and Computational Modeling Supports a Critical Role of Lead Location in Determining Outcomes for Deep Brain Stimulation: A Case Report. Front Hum Neurosci. 2021;15:631778. 5. Plantinga BR, Temel Y, Duchin Y, et al. Individualized parcellation of the subthalamic nucleus in patients with Parkinson's disease with 7T MRI. NeuroImage. Mar 2018;168:403-411. 6. Nowacki A, Barlatey S, Al-Fatly B, et al. Probabilistic Mapping Reveals Optimal Stimulation Site in Essential Tremor. Ann Neurol. May 2022;91(5):602-612. 7. Akram H, Sotiropoulos SN, Jbabdi S, et al. Subthalamic deep brain stimulation sweet spots and hyperdirect cortical connectivity in Parkinson's disease. NeuroImage. Sep 2017;158:332-345. 8. Jaradat A, Nowacki A, Montalbetti M, et al. Probabilistic Subthalamic Nucleus Stimulation Sweet Spot Integration Into a Commercial Deep Brain Stimulation Programming Software Can Predict Effective Stimulation Parameters. Neuromodulation. Feb 2023;26(2):348-355. 9. Rijks N, Potters WV, Dilai J, et al. Combining 7T T2 and 3T FGATIR: from physiological to anatomical identification of the subthalamic nucleus borders. J Neurol Neurosurg Psychiatry. Feb 19 2022. 10. Bot M, Verhagen O, Caan M, et al. Defining the Dorsal STN Border Using 7.0-T MRI: A Comparison to Microelectrode Recordings and Lower Field Strength MRI. Stereotact Funct Neurosurg. 2019;97(3):153-159.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The STEREO-DBS Study: 7-Tesla MRI Brain Network Analysis for Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT05843084
- Acronym / sponsor ID
- STEREO-DBS / W20_540 # 20.599
- Conditions
- Parkinson Disease, Diffusion Magnetic Resonance Imaging, Brain, Subthalamic Nucleus, Deep Brain Stimulation, Human
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 11 Apr 2033 (estimated)
- Study completion
- 11 Apr 2033 (estimated)
- First posted
- 6 May 2023 (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.
Rationale: Deep brain stimulation (DBS) of the nucleus subthalamicus (STN) is an effective surgical treatment for the patients with advanced Parkinson's disease, despite optimal pharmacological treatment. However, individual improvement after DBS remains variable and 50% of patients show insufficient benefit. To date, DBS-electrode placement and settings in the highly connected STN are based on 1,5-Tesla or 3-Tesla MR-images. These low resolution and solely structural modalities are unable to visualize the multiple brain networks to this small nucleus and prevent electrode activation directed at its cortical projections. By using structural 7-Tesla MRI (7T MRI) connectivity to visualize (malfunctioning) brain networks, DBS-electrode placement and activation can be individualized.
Objective: Primary objective of the study is to determine whether visualisation of cortical projections originating in the STN and the position of the DBS electrode relative to these projections using 7T MRI improves motor symptoms as measured by the disease-specific Unified Parkinson's Disease Rating Scale (UPDRS-III).
Secondary outcomes are: disease related daily functioning, adverse effects, operation time, quality of life, patient satisfaction with treatment outcome and patient evaluation of treatment burden.
Study design: The study will be a single center prospective observational study.
Study population: Enrollment will be ongoing from April 2022. Intervention (if applicable): No intervention will be applied. Application of 7T MRI for DBS is standard care and outcome scores used will be readily accessible from the already existing advanced electronic DBS database.
Main study parameters/endpoints: The primary outcome measure is the change in motor symptoms as measured by the disease-specific Unified Parkinson's Disease Rating Scale (UPDRS-III). This is measured after 6 months of DBS as part of standard care. The secondary outcome measures are the Amsterdam Linear Disability Score for functional health status, Parkinson's Disease Questionnaire 39, Starkstein apathy scale, patient satisfaction with the treatment, patient evaluation of treatment burden, operating time, hospitalization time, change of tremor medication, side effects and complications.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The proposed observational research project involves treatment options that are standard care in daily practice. The therapies will not be combined with other research products. Participation in this study constitutes negligible risk according to NFU criteria for human research.
Detailed description
INTRODUCTION AND RATIONALE
Deep brain stimulation for Parkinson's disease Deep brain stimulation (DBS) is an effective treatment in Parkinson's disease (PD), a debilitating neurological disorder. The effect of DBS relies on the modulation of malfunctioning brain networks by delivering electrical pulses within the subthalamic nucleus, deeply seated in the brainstem and the size of a few millimeters (STN; comparable to the size of a coffee bean). However, individual improvement after DBS remains variable and 50% of patients show insufficient benefit. By using structural 7-Tesla magnetic resonance imaging (7T MRI) connectivity to visualize malfunctioning networks, DBS-electrode placement and activation can be individualized.
Current DBS-electrode placement and settings in the highly connected STN are based on 1.5-Tesla or 3-Tesla MR-images. These low resolution modalities are unable to visualize the multiple brain networks to this small nucleus and prevent electrode activation directed at its cortical projections. Integrated structural (7T MRI) network maps will enable brain network-based and patient-specific DBS, improving motor symptoms and quality of life.
7T MRI brain network analysis Since the 1980s, DBS for PD was targeting the STN, a deep-seated grey matter brain nucleus. Current emphasis in the field of DBS is on neural networks rather than separate nuclei in the brain. Several studies showed PD to arise from pathological network activity in subthalamic-cortical projections. In recent years several DBS groups reported about using MRI connectivity to visualize the subthalamic-cortical projections, in DBS for PD.
The small STN is part of multiple large brain networks. DBS is effective in improving UDPRS and quality of life for PD patients only by modulating its motor network. For improving DBS placement and activation, it is essential to understand the networks and the modulatory effect of stimulation. Thus far, visualization of these networks was limited due to low resolution and the lack of structural connectivity (visualising subthalamic-cortical projections using diffusion weighted MRI and probabilistic connectivity).
The investigators therefore added 7T T2 and diffusion-weighted sequences at the Spinoza Centre and showed that probabilistic subthalamic network analyses (STN segmentation) successfully identifies the area within the STN that has the highest density of connections with the motor network in PD patients. In a recent pilot study the investigators showed the implementation of 7T MRI for STN segmentation is well suited within the existing surgical workflow. By generating a 7-Tesla MRI showing the STN (coloured) motor subdivision, this technique clearly visualized this new DBS target. The retrospective analysis showed for conventional MRI targeting strategies only a minority of DBS electrodes were placed in the motor STN. Moreover, the DBS electrodes that were placed in the motor STN resulted in a significantly higher mean improvement (80% versus 50%, measured by the UPDRS-III score).
Generating the 7T MRI network maps for DBS The STN and its cortical connections will be visualized using 7T T2-weighted and diffusion weighted imaging. Three major projections of the STN will be visualised: projections connecting to primary and supplementary motor cortex (motor), projections to the prefrontal cortex (associative) and projections to the basofrontal cortex (limbic). The location of the electrode (using computed tomography) will be visualised relative to the three segmented subdivisions of the STN.
The 7T MRI network map, generated by combining T2 and diffusion weighted MRI, shows the STN (coloured) subdivisions and their cortical projections. The result will then show in which STN subdivision(s) the DBS-electrode contact is situated and to which cortical area the STN subdivision projects. Clinical test scores of the electrode contact will then be correlated to the network maps. Stimulation parameters based on 7T MRI network maps are used to optimize and predict outcome in terms of beneficial clinical effects (suppression tremor, bradykinesia, rigidity) and side effects (speech, gait, apathy). As all network maps are visualised on MRI, this will readily enable both individual and group analyses (co-registrating maps of multiple patients).
Adverse effects In the 350 7T MR-scans the investigators have performed to date, we rarely encountered non-compatible implants or severe claustrophobia. Every patient undergoes screening with a MRI safety questionnaire and MRI metal detector (preventing taking ferromagnetic materials into the MRI). 7T MRI is a non-invasive technique which causes no pain and, importantly, the electromagnetic fields produce no known tissue damage of any kind. The MR system may make loud tapping, knocking, or other noises at times during the procedure. Earplugs are provided to prevent problems that may be associated with noise generated by the scanner. At all times, the patient will be (visually) monitored and will be able to communicate with the 7T MRI technologist using an intercom system. The patient may (request to) stop the acquisition at any time by using the push button (hold by the patient continuously).
In sum, due to implementation of 7T MRI brain network analysis, it is now possibly to directly visualize the motor part of the STN. In current observational study this technique will be evaluated in a prospective fashion, introducing patient specific brain network-guided DBS for PD with delivering a unique and hitherto unavailable dataset: 7T MRI visualizes the anatomical connections of the STN for each individual DBS electrode contact. Instead of a one-DBS-fits all model, the tailored network analyses enable personalized precision modelling in DBS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- STUDY POPULATION 1.1 Population (base) Patients with advanced Parkinson's disease who underwent DBS electrode placement using 7T MRI network analysis. If the patient is eligible, the physician coordinating the study will inform the patient, hand over written information about the observational study, and subsequently ask the patient to consider participation. If the patient wants to participate, the informed consent form will be signed. Patients will be given as much time as needed to decide whether to participate in the study. Enrollment will be ongoing from April 2023; patients who underwent 7T MRI network analysis based DBS before this date will also be eligible to participate (all DBS patients are registered in the prospective electronic Castor database).
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 |
|---|---|---|
| 7T MRI network analysis for deep brain stimulation in Parkinson's diseaseWe hypothesize that the implementation of 7T MRI network analysis can enhance the effectiveness of DBS by improving motor symptoms and quality of life in PD patients. | Procedure or surgery | – |
Primary outcome
Unified Parkinson's Disease Rating Scale (UPDRS-III)
Time frame: April 2022 - April 2033
The amount of decrease in motor symptoms indicated by change in the disease-specific Unified Parkinson's Disease Rating Scale (UPDRS-III) after six months of deep brain stimulation. The UPDRS-III scores are between 7 and 86; higher scores indicating worse (more severe) motor symptoms.
3 secondary outcomes
The Amsterdam Linear Disability Score for functional health status
Time frame: April 2022 - April 2033
Parkinson's disease questionnaire-39
Time frame: April 2022 - April 2033
Starkstein apathy scale
Time frame: April 2022 - April 2033
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 25 Jul 2025.
- Background1. Bloem BR, Okun MS, Klein C. Parkinson's disease. Lancet. Apr 9 2021. 2. Bot M, Schuurman PR, Odekerken VJJ, et al. Deep brain stimulation for Parkinson's disease: defining the optimal location within the subthalamic nucleus. J Neurol Neurosurg Psychiatry. May 2018;89(5):493-498. 3. Mathiopoulou V, Rijks N, Caan MWA, et al. Utilizing 7-Tesla Subthalamic Nucleus Connectivity in Deep Brain Stimulation for Parkinson Disease. Neuromodulation. Feb 22 2022. 4. Schrock LE, Patriat R, Goftari M, et al. 7T MRI and Computational Modeling Supports a Critical Role of Lead Location in Determining Outcomes for Deep Brain Stimulation: A Case Report. Front Hum Neurosci. 2021;15:631778. 5. Plantinga BR, Temel Y, Duchin Y, et al. Individualized parcellation of the subthalamic nucleus in patients with Parkinson's disease with 7T MRI. NeuroImage. Mar 2018;168:403-411. 6. Nowacki A, Barlatey S, Al-Fatly B, et al. Probabilistic Mapping Reveals Optimal Stimulation Site in Essential Tremor. Ann Neurol. May 2022;91(5):602-612. 7. Akram H, Sotiropoulos SN, Jbabdi S, et al. Subthalamic deep brain stimulation sweet spots and hyperdirect cortical connectivity in Parkinson's disease. NeuroImage. Sep 2017;158:332-345. 8. Jaradat A, Nowacki A, Montalbetti M, et al. Probabilistic Subthalamic Nucleus Stimulation Sweet Spot Integration Into a Commercial Deep Brain Stimulation Programming Software Can Predict Effective Stimulation Parameters. Neuromodulation. Feb 2023;26(2):348-355. 9. Rijks N, Potters WV, Dilai J, et al. Combining 7T T2 and 3T FGATIR: from physiological to anatomical identification of the subthalamic nucleus borders. J Neurol Neurosurg Psychiatry. Feb 19 2022. 10. Bot M, Verhagen O, Caan M, et al. Defining the Dorsal STN Border Using 7.0-T MRI: A Comparison to Microelectrode Recordings and Lower Field Strength MRI. Stereotact Funct Neurosurg. 2019;97(3):153-159.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Maarten Bot, MD PhD principal investigator
Amsterdam UMC
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 Disease and Diffusion Magnetic Resonance Imaging, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 25 Jul 2025. 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 Netherlands. 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 Maarten Bot, MD PhD (0031621514048, m.bot@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Parkinson's Disease Rating Scale (UPDRS-III) (time frame: April 2022 - April 2033). 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 NCT05843084, 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 25 Jul 2025; AzTrials last refreshed its copy on 30 Oct 2026.