Digitizing Non-Invasive Neuromodulation Trials: Scoping Review, Process Mapping, and Recommendations from a Delphi Panel

Abstract

Although relatively costly and non-scalable, non-invasive neuromodulation interventions are treatment alternatives for neuropsychiatric disorders. The recent developments of highly-deployable transcranial electric stimulation (tES) systems, combined with mobile-Health technologies, could be incorporated in digital trials to overcome methodological barriers and increase equity of access. We convened 61 highly-productive specialists and contacted 8 tES companies to assess 71 issues related to tES digitalization readiness, and processes, barriers, advantages, and opportunities for implementing tES digital trials. Delphi-based recommendations (>60% agreement) were provided. Device appraisal showed moderate digitalization readiness, with high safety and possibility of trial implementation, but low connectivity. Panelists recognized the potential of tES for scalability, generalizability, and leverage of digital trials processes; although they reached no consensus about aspects regarding methodological biases. We further propose and discuss a conceptual framework for exploiting shared aspects between mobile-Health tES technologies with digital trials methodology to drive future efforts for digitizing tES trials.

Closing the loop between brain and electrical stimulation: Towards precision neuromodulation treatments

“…Understanding the therapeutic susceptibility to NIBS via data obtained from functional imaging, such as fMRI measures in closed-loop tES-fMRI systems, will help to develop patient-tailored tES strategies towards precision medicine and personalized nonpharmacological therapy [129]. The optimized parameters that are defined for each individual can be potentially used outside the scanner and even in home use settings through portable tES devices [130]. The success of closedloop tES-fMRI in clinical applications will largely depend on the development of brain-based biomarkers to translate the observed transient stimulation effects to a sustainable recovery in patients.…”