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Assessment of the MR compatibility of a subcutaneous migraine implant
Geurink, Bas (2025) Assessment of the MR compatibility of a subcutaneous migraine implant.
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| Abstract: | Migraine is a neurological disorder that affects up to 15 percent of the adult population and is associated with a significant socio-economic burden and reduction in quality of life. Conventional treatment methods are often ineffective and cause severe side effects. This research investigates the MR compatibility of a novel subcutaneous neurostimulation device designed to relieve the symptomology of (chronic) migraine. Its unique characteristics with respect to other neurostimulators raises interest and need for a dedicated evaluation of its safety within an MRI environment (mainly 1.5T). The ISO/TS 10974:2018 on the MR compatibility of Active Implantable Medical Devices (AIMD) provided a framework for the experimental setup including the evaluation of translational force, torque and demagnetisation induced by the static magnetic field (B_0), RF- and gradient induced heating, functionality of the AIMD after exposure to the electromagnetic fields of an MRI and an assessment of the induced image artifacts. Results have shown that the AIMD experienced reasonable translational forces (max. 1 N) and substantial torque (max. 0.068 Nm). No demagnetisation was found for 1.5T systems. 3.0T and 7.0T systems resulted in significant orientational dependent demagnetisation (>100%). The simulated RF induced heating amounted to max. ±2.3 W/kg with hotspots localized near the eighth electrode of the lead. Experimentally, a temperature increase of max. 1.28 °C was found. Gradient induced heating was not observed. None of the experiments caused dysfunctionality of the AIMD. These findings seem to offer a good perspective for MR compatibility labelling in 1.5T systems. However, the torque can potentially be problematic and lead to dislocation or rotation of the internal magnet or the AIMD. The max. RF-induced heating is also not compliant with the safety limit. However, this is a conservative analysis which means less significant heating may occur in practice. In addition, a CEM43 analysis showed that the risk of tissue damage due to heating is minimal. |
| Item Type: | Essay (Master) |
| Faculty: | TNW: Science and Technology |
| Subject: | 33 physics, 42 biology, 44 medicine, 52 mechanical engineering |
| Programme: | Biomedical Engineering MSc (66226) |
| Link to this item: | https://purl.utwente.nl/essays/107837 |
| Export this item as: | BibTeX EndNote HTML Citation Reference Manager |
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