The STEREO-DBS Study: 7-Tesla MRI Brain Network Analysis for Deep Brain Stimulation
STEREO-DBS
1 other identifier
observational
500
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 11, 2022
CompletedFirst Submitted
Initial submission to the registry
April 11, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 11, 2033
July 25, 2025
July 1, 2025
11 years
April 11, 2023
July 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
April 2022 - April 2033
Secondary Outcomes (3)
The Amsterdam Linear Disability Score for functional health status
April 2022 - April 2033
Parkinson's disease questionnaire-39
April 2022 - April 2033
Starkstein apathy scale
April 2022 - April 2033
Interventions
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.
Eligibility Criteria
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).
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Amsterdam UMC, location AMC
Amsterdam, North Holland, 11015AZ, Netherlands
Related Publications (1)
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.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maarten Bot, MD PhD
Amsterdam UMC
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Associative Professor
Study Record Dates
First Submitted
April 11, 2023
First Posted
May 6, 2023
Study Start
April 11, 2022
Primary Completion (Estimated)
April 11, 2033
Study Completion (Estimated)
April 11, 2033
Last Updated
July 25, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- From april 2022
all IPD that underlie results in a publication