The BRAINMAP-DBS Study: BRain Network AnalysIs usiNg 7-Tesla MRI and MAgnetoencephalograPhy for Deep Brain Stimulation

NCT06932692 | Recruiting DMC

• 3 other identifiers: NL86080.018.241096010231002209032232310059
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Deep brain stimulation (DBS) is an effective treatment for essential tremor and Parkinson's disease. The effect of DBS relies on the modulation of dysfunctional motor brain networks and on average 50% motor improvement is achieved, using standardized motor evaluation scores. However, approximately 20% of treated patients show insufficient benefit, with less than 30% improvement. To improve outcomes through better electrode placement and selection of DBS electrical parameter programming, more advanced visualization of motor networks is needed; both anatomical (7-Tesla MRI) and functional (magnetoencephalography, MEG). Current DBS implantations are based on 1.5- or 3- Tesla MR scans. The resolution of these scans is not sufficient to visualize brain networks, preventing electrode placement directed at motor parts within the brain nucleus. In addition to the 7-Tesla MRI guided electrode placement, by applying MEG, programming will be directed at influencing the cortical motor areas, resulting in an overall decrease in dysfunctional network activity. Objective: Primary objective of the study is to determine whether brain network visualization using 7T MRI and MEG improves motor symptoms as measured by the disease-specific Unified Parkinson's Disease Rating Scale (UPDRS-III) and Tremor Assessment Rating Scale (TETRAS); and quality of life as measured by the Parkinson's Disease Questionnaire 39 (PDQ-39). Secondary outcomes are: disease related daily functioning, adverse effects, operation time, quality of life (QUEST), patient satisfaction with treatment outcome and patient evaluation of treatment burden. Study design: Single-center, prospective study with repeated measures; standardized assessments of motor skills and quality of life (UPDRS-III, TETRAS, PDQ-39) after DBS placement will be compared with scores after adjustments based on network analyses. Study population: Enrollment will be ongoing from April 2024. Intervention (if applicable): Patients with DBS for a minimum of six months will undergo an additional MEG scan. 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 co-primary outcome measures are the change in motor symptoms (measured by the UPDRS-III,TETRAS) and quality of life (measured by the PDQ-39). This is measured as part of standard care. The secondary outcome measures are the Amsterdam Linear Disability Score for functional health status, Starkstein apathy scale, Quality of Life Questionnaire in Essential Tremor (QUEST), patient satisfaction with the treatment, patient evaluation of treatment burden, operating time, hospitalization time, change of tremor medication, side effects and complications. The primary and secondary outcome scores are already stored in our advanced electronic DBS database. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The 7-Tesla MRI and MEG protocols (including stimulation parameters) already developed by our group and reported in (five) studies will be applied. After selecting the best DBS programming, the aim is to optimize DBS outcome by: a) increasing the mean improvement in motor function and quality of life by at least 10% and b) achieving a minimum of 30% improvement in motor function for each patient (measured by standardized assessment of motor function and quality of life). The proposed research project involves treatment options that are non-invasive and/or part of 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.

Conditions

Deep Brain Stimulation; Parkinson Disease; Essential Tremor; Magnetoencephalography (MEG); MRI

Keywords

Deep Brain Stimulation; Parkinson's disease; Essential Tremor; 7 Tesla MRI; Magnetoencephalography; Brain networks

Outcome Measures

Primary Outcomes (3)

• Essential Tremor Rating Assessment Scale (TETRAS)

  The amount of decrease in motor symptoms indicated by change in the disease-specific Essential Tremor Rating Assessment Scale (TETRAS) after six months of deep brain stimulation. The TETRAS scores are between 0 and 64; higher scores indicating worse (more severe) tremor symptoms.

  assessment will be done before DBS and after 6 months of DBS

• 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.

  assessment will be done before DBS and after 6 months of DBS

• 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.

  assessment will be done before DBS and after 6 months of DBS

Secondary Outcomes (3)

• The Amsterdam Linear Disability Score for functional health status

  assessment will be done before DBS and after 6 months of DBS

• Starkstein apathy scale

  assessment will be done before DBS and after 6 months of DBS

• Quality of Life in Essential Tremor Questionnaire

  assessment will be done before DBS and after 6 months of DBS

Study Arms (1)

Magnetoencephalography

OTHER

Patients with DBS for a minimum of six months will undergo an additional MEG scan (intervention, for all participants). 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.

Other: magnetoencephalography

Interventions

magnetoencephalography OTHER

500 patients with Parkinson's disease and essential tremor will undergo magnetoencephalography

Magnetoencephalography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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/ET with at least six months of DBS
• Underwent a preoperative 7-Tesla MRI scan

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.
• A spinal stimulation or deep brain stimulation system is not compatible with 7-Tesla MRI
• There a no implants inadmissible in the MEG, although patients will be questioned for possible (non-removable) implants such as pacemakerand/or dental as they may interfere with the magnetic signals

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1011AZ, Netherlands

RECRUITING

Related Publications (5)

• Boon LI, Hillebrand A, Potters WV, de Bie RMA, Prent N, Bot M, Schuurman PR, Stam CJ, van Rootselaar AF, Berendse HW. Motor effects of deep brain stimulation correlate with increased functional connectivity in Parkinson's disease: An MEG study. Neuroimage Clin. 2020;26:102225. doi: 10.1016/j.nicl.2020.102225. Epub 2020 Feb 21.

  PMID: 32120294 BACKGROUND

• Boon LI, Potters WV, Hillebrand A, de Bie RMA, Bot M, Richard Schuurman P, van den Munckhof P, Twisk JW, Stam CJ, Berendse HW, van Rootselaar AF. Magnetoencephalography to measure the effect of contact point-specific deep brain stimulation in Parkinson's disease: A proof of concept study. Neuroimage Clin. 2023;38:103431. doi: 10.1016/j.nicl.2023.103431. Epub 2023 May 10.

  PMID: 37187041 BACKGROUND

• Zoon TJC, Mathiopoulou V, van Rooijen G, van den Munckhof P, Denys DAJP, Schuurman PR, de Bie RMA, Bot M. Apathy following deep brain stimulation in Parkinson's disease visualized by 7-Tesla MRI subthalamic network analysis. Brain Stimul. 2023 Sep-Oct;16(5):1289-1291. doi: 10.1016/j.brs.2023.08.013. Epub 2023 Aug 22.

  PMID: 37619890 BACKGROUND

• Mathiopoulou V, Rijks N, Caan MWA, Liebrand LC, Ferreira F, de Bie RMA, van den Munckhof P, Schuurman PR, Bot M. Utilizing 7-Tesla Subthalamic Nucleus Connectivity in Deep Brain Stimulation for Parkinson Disease. Neuromodulation. 2023 Feb;26(2):333-339. doi: 10.1016/j.neurom.2022.01.003. Epub 2022 Feb 23.

  PMID: 35216874 BACKGROUND

• Verlaat L, Rijks N, Dilai J, Admiraal M, Beudel M, de Bie RMA, van der Zwaag W, Schuurman R, van den Munckhof P, Bot M. 7-Tesla Magnetic Resonance Imaging Scanning in Deep Brain Stimulation for Parkinson's Disease: Improving Visualization of the Dorsolateral Subthalamic Nucleus. Mov Disord Clin Pract. 2024 Apr;11(4):373-380. doi: 10.1002/mdc3.13982. Epub 2024 Feb 22.

  PMID: 38385792 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor

Interventions

Magnetoencephalography

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Magnetometry; Investigative Techniques

Central Study Contacts

Maarten Bot Bot, MD PhD

CONTACT

0031621514048; m.bot@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Intervention: Patients with DBS for a minimum of six months will undergo an additional MEG scan. 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.

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 17, 2025
• Study Start: April 23, 2024
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)