Periodic Reporting for period 1 - NextGEM (Next Generation Integrated Sensing and Analytical System for Monitoring and Assessing Radiofrequency Electromagnetic Field Exposure and Health)
Période du rapport: 2022-07-01 au 2023-12-31
The NextGEM vision is to assure safety for EU citizens when employing existing and future EMF based telecommunication technologies. This will be accomplished by generating relevant knowledge that ascertains appropriate prevention and control/actuation actions of EMF exposure in residential, public, and occupational settings. Fulfilling the vision will provide a healthy living and working environment, under safe EMF exposure conditions, that can be trusted by people and be in line with the regulations and laws of the public authorities. For that, NextGEM will provide a framework for the generation of health-relevant scientific knowledge and data on new scenarios of exposure to EMF in multiple frequency bands, and develop and validate tools for evidence based risk assessment. NextGEM will also create the NextGEM Innovation and Knowledge Hub (NIKH) for EMF and Health offering a standardised way for European regulatory authorities and the scientific community to store and assess project outcomes, and provide access to FAIR data.. NextGEM is part of the European cluster on EMFs and health.
A thorough review of the instruments (both commercial as well as custom design) capable of measuring the field intensity for RF EMF exposure in both FR1 and FR2 has been carried out by the partners. The simulation/modelling activity for the FR2 sensor has been completed. The capability to generate 5G compliant signals to be employed in the FR2 emulative scenarios is successfully completed.
The EM solver (ERMES) has been improved to allow for the simulation of body parts (i.e. head, torso, etc.) up to the FR2 band by employing surface models. The ERMES functionalities have been tuned to allow simulation up to FR2 bands. The simulations for coverage and exposure of realistic indoor and outdoor environments are currently being executed.
The simulations for coverage and exposure of realistic indoor and outdoor environments are currently being executed. The partners set up a structured approach to simulate both the coverage and exposure in realistic outdoor and indoor environments. A full urban grid (based on the modified Madrid grid) has been implemented and simulated allowing the analysis of realistic scenarios with multiple users, with a time resolution of a single transmit frame (i.e. a few milliseconds).
A variety of experimental procedures for mechanistic investigations, in vitro, ex vivo and in vivo studies have been developed. Preliminary results of mechanistic investigations have been gained, which need to be extended and validated. The exposure systems to be used for the experimental activities have been validated and the first results on dosimetry have been presented. The ethical committee approval for the pilot study on human volunteers has been obtained.
Significant progress has been made in developing the NIKH, marked by the initial collection of system requirements and the development of a functional architecture. Work is currently focused on defining interactions between NIKH components through sequence diagrams and establishing a holistic monitoring system for reliability.
The assessment of the evidence for a potential causal association between EMF exposure and cancer in humans is advancing and the methodology on umbrella reviews of epidemiological studies has been developed and delivered, which now is applied in preparation for the first umbrella review. The development of a risk assessment tool ongoing leading to the NIKH dashboard that is currently in the focus, following the FAIR principles-compatible dashboard. Data for validation of the RA tool model is currently acquired and analysed for appropriateness.
The EM solver (ERMES) has been improved to allow for the simulation of body parts (i.e. head, torso, etc.) up to the FR2 band by employing surface models. The ERMES functionalities have been tuned to allow simulation up to FR2 bands. The simulations for coverage and exposure of realistic indoor and outdoor environments are currently being executed.
The simulations for coverage and exposure of realistic indoor and outdoor environments are currently being executed. The partners set up a structured approach to simulate both the coverage and exposure in realistic outdoor and indoor environments. A full urban grid (based on the modified Madrid grid) has been implemented and simulated allowing the analysis of realistic scenarios with multiple users, with a time resolution of a single transmit frame (i.e. a few milliseconds).
A variety of experimental procedures for mechanistic investigations, in vitro, ex vivo and in vivo studies have been developed. Preliminary results of mechanistic investigations have been gained, which need to be extended and validated. The exposure systems to be used for the experimental activities have been validated and the first results on dosimetry have been presented. The ethical committee approval for the pilot study on human volunteers has been obtained.
Significant progress has been made in developing the NIKH, marked by the initial collection of system requirements and the development of a functional architecture. Work is currently focused on defining interactions between NIKH components through sequence diagrams and establishing a holistic monitoring system for reliability.
The assessment of the evidence for a potential causal association between EMF exposure and cancer in humans is advancing and the methodology on umbrella reviews of epidemiological studies has been developed and delivered, which now is applied in preparation for the first umbrella review. The development of a risk assessment tool ongoing leading to the NIKH dashboard that is currently in the focus, following the FAIR principles-compatible dashboard. Data for validation of the RA tool model is currently acquired and analysed for appropriateness.
The main key enabling ambitions are aligned with the innovative objectives of NextGEM are the following:
- 5G exposure patterns: NextGEM accomplish necessary and much sought-after improvements in field level assessment in real scenarios by developing a maximum power extrapolation technique and a suitable statistical model for FPR factor estimation for application in both Single User (SU) MIMO and Multiple Users (MU) MIMO cases. Validation will be performed in a dedicated case study by developing novel high frequency EMF sensing devices.
- EMF modelling tools: NextGEM will develop next-generation, game changing open-source computational tools (ERMES, Ray-it) for environmental EMF levels and body-absorbed RF energy measurements, which will be made freely available to the general public at the end of the project. New numerical algorithms will be tested and validated to improve the numerical efficiency and accuracy. New interfaces (ray-tracing with human-body geometry and full-wave EM solver) and capabilities (coupling EM with other physical models) will be developed, further advancing EMF modelling in complex environments.
- In vitro and in vivo investigations: NextGEM will use different -omics approaches to identify genes and proteins as potential exposure marker candidate. The obtained results will be the foundation for hazard and risk assessments within the NextGEM project, allowing these activities to be performed more accurately than previously.
- Physics of the processes initiated by exposure of living cells to EMF: NextGEM will accomplish significant knowledge advancement regarding possible impact of EMF on: (i) protonation and modifications of thiols and amino groups of amino acids, (ii) state of water and protein surface charge and structure, (iii) membrane potential and surface charge. Frequencies dependency, response kinetics and duration, as well as tissue-specificity will be studied. Such mechanistic understanding is crucial to understand if non-thermal EMF are at all possible, and if so, under which circumstances.
- Human studies: NextGEM will conduct a pilot study of healthy volunteers (double-blind) after exposure to 5G carrier frequencies and modulation envelopes, to detect potential acute effects on physiological cell parameters, genetic material integrity and gene expression in human blood cells (RBC, lymphocytes).
- Umbrella review of neoplasia risks from EMF exposure in humans: NextGEM possess the methodological and subject-matter expertise required for a critical summary of findings from SRs of epidemiological and experimental studies of the effect of EMF exposure on cancer and also on reproductive outcomes, and will focus on these hazards.
- Health risk assessment: NextGEM will ensure this by a pronounced stakeholder involvement, integration of novel exposure and dosimetry methodologies for RF exposure assessment, and identification of health relevant markers in experimental bio-effects studies. A unique RA tool for use by different stakeholders will be developed and validated in case studies.
- 5G exposure patterns: NextGEM accomplish necessary and much sought-after improvements in field level assessment in real scenarios by developing a maximum power extrapolation technique and a suitable statistical model for FPR factor estimation for application in both Single User (SU) MIMO and Multiple Users (MU) MIMO cases. Validation will be performed in a dedicated case study by developing novel high frequency EMF sensing devices.
- EMF modelling tools: NextGEM will develop next-generation, game changing open-source computational tools (ERMES, Ray-it) for environmental EMF levels and body-absorbed RF energy measurements, which will be made freely available to the general public at the end of the project. New numerical algorithms will be tested and validated to improve the numerical efficiency and accuracy. New interfaces (ray-tracing with human-body geometry and full-wave EM solver) and capabilities (coupling EM with other physical models) will be developed, further advancing EMF modelling in complex environments.
- In vitro and in vivo investigations: NextGEM will use different -omics approaches to identify genes and proteins as potential exposure marker candidate. The obtained results will be the foundation for hazard and risk assessments within the NextGEM project, allowing these activities to be performed more accurately than previously.
- Physics of the processes initiated by exposure of living cells to EMF: NextGEM will accomplish significant knowledge advancement regarding possible impact of EMF on: (i) protonation and modifications of thiols and amino groups of amino acids, (ii) state of water and protein surface charge and structure, (iii) membrane potential and surface charge. Frequencies dependency, response kinetics and duration, as well as tissue-specificity will be studied. Such mechanistic understanding is crucial to understand if non-thermal EMF are at all possible, and if so, under which circumstances.
- Human studies: NextGEM will conduct a pilot study of healthy volunteers (double-blind) after exposure to 5G carrier frequencies and modulation envelopes, to detect potential acute effects on physiological cell parameters, genetic material integrity and gene expression in human blood cells (RBC, lymphocytes).
- Umbrella review of neoplasia risks from EMF exposure in humans: NextGEM possess the methodological and subject-matter expertise required for a critical summary of findings from SRs of epidemiological and experimental studies of the effect of EMF exposure on cancer and also on reproductive outcomes, and will focus on these hazards.
- Health risk assessment: NextGEM will ensure this by a pronounced stakeholder involvement, integration of novel exposure and dosimetry methodologies for RF exposure assessment, and identification of health relevant markers in experimental bio-effects studies. A unique RA tool for use by different stakeholders will be developed and validated in case studies.