DeNeCoR - Devices for NeuroControl and NeuroRehabilitation
All neuromodulation systems currently available are not MR Safe, implying that patients suffering from neurodegenerative diseases (e.g. Parkinson) can only be diagnosed using MRI with severe restrictions after the implantation of neuromodulation devices. This drastically limits the options for clinicians for further treatment of patients, requireing MR Conditional devices.
The primary objective of DeNeCoR is to resolve this issue such that electronic neuromodulation therapy will become well established, including new possibilities to scan patients with neuromodulation devices using MRI. As a starting point the consortium partners will derive requirements for both therapy devices and imaging systems from Technical Specification IEC/ISO 10974, which has been drafted by the joint committe work of Active Implanted Medical Devices manufacturers (AIMD) and MRI manufacturers, Regulatory Agencies and MR Testing Service Providers. While the current version of ISO/TS has a scope for closed bore 1.5 Tesla MR systems, DeNeCor aims for transferring the ISO/TS methods to a 3 Telsa MR environment. For implanted therapeutic devices the Technical Specification poses technical challenges for miniaturization of electronics and packaging including shielding. Regarding MRI aspects, MR Conditional devices & systems will need to be optimized to accomplish the new challenges concerning magnetic field generation and detection circuitry, topology and embedded software control. The feasibility demonstration in the DeNeCoR project will contribute to the validation of the Technical Specification IEC/ISO 10974.
The second objective of DeNeCoR is to extrapolate IEC/ISO 10974 specifications to other diagnostic systems and to the interaction between diagnostic systems and non-invasive electronics based neuromodulation therapies. In particular this objective of DeNeCoR targets the following topics:
- Demonstration of an MR Conditional Transcranial Magnetic Stimulator (TMS) with focused spatial localization. This requires distribution and miniaturization of power electronics.
- Development of new sensor and packaging technology for invasive and non-invasive neural sensing (e.g. EEG), conditional safe with the MRI and TMS environment. Demonstration includes connection to neuro-modulation and neuro-rehabilitation devices.
- Demonstration of an MR Conditional MRI-guided endoscopic system with integrated ultrasound system, based on innovative Capacitive Micromachined Ultrasound Transducers (CMUT), miniaturization of electronics and 3D packaging.
The third objective of DeNeCoR is to develop test methods such that the development of therapy devices and diagnostic systems can be decoupled. This increases the efficiency of the developments and enables technical evolution of all systems at their own pace. In addition, several test methods are currently not described in the Technical Specification IEC/ISO 10974, whereas they are essential for its transformation in to an international safety standard.
The measurements of electromagnetic fields (EMF), which are essential to support the electronic development in DeNeCoR, will create new inputs for the assessment of EMF interactions with the human Central Nervous System (CNS). This assessment is necessary because of occupational and patient health and safety guidelines developed by e.g. the World Health Organization (WHO), the International Commission on Non-Ionizing Radiation Protection (ICNIRP) and the Institute of Electrical and Electronics Engineers (IEEE).
Today neuromodulation therapy is typically perceived as a treatment of the last resort. DeNeCoR aims at yielding a higher preference rate among clinicians by removing the main roadblock of incompatibility between neuromodulation therapy (DBS & TMS) and neurological diagnostic systems (EEG, MRI & US).
Amongst other partner, MR:comp is the special DeNeCor partner for intergration of the ISO/TS MR test methods and transfer to AIMDs, but also non-AIMD devices speciality. Also MR:comp's numerical and experimental expertise is used to describe the MR-realistic 3 Tesla RF environment and establish testing capabilies togehter with other project partners.
This project is supported by ENIAC JU Projects' Consortium Agreement – EPCA, Project: DeNeCoR.
More information about DeNeCor: http://www.denecor.info/