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

RecruitingNAAges 18 Years - anyAllAcademisch Medisch Centrum - Universiteit van Ams…
NCT06932692 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 el

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📋 Eligibility rules (as published)
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/ET with at least six months of DBS * Underwent a preoperative 7-Tesla MRI scan 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. * 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
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What it tests

  • magnetoencephalography
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Where

1 site
Amsterdam UMC
Amsterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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