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

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · 2024
ClinicalTrials.gov · Datasets · License: Public Domain · 2024
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brain-networksdeep-brain-stimulationmagnetoencephalographymrinaparkinson-diseases-disease
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 wit
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