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Digitalized transcranial electrical stimulation: A consensus statement.

Andre R Brunoni¹, Hamed Ekhtiari², Andrea Antal³

¹Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil; Department of Internal Medicine, Faculdade de Medicina da Universidade de São Paulo & Hospital Universitário, Universidade de São Paulo, São Paulo, Brazil; Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Service of Interdisciplinary Neuromodulation (SIN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.

Clinical Neurophysiology : Official Journal of the International Federation of Clinical Neurophysiology

|September 17, 2022

Summary

This summary is machine-generated.

Non-invasive neuromodulation using transcranial electrical stimulation (tES) shows promise for neuropsychiatric disorders. Integrating tES with digital trials and mobile-Health technologies can improve scalability and access, overcoming current limitations.

Keywords:

Delphi panel Digital health Mobile Health Non-invasive neuromodulation Systematic review

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Area of Science:

Neuroscience
Digital Health
Clinical Trials

Background:

Non-invasive neuromodulation offers alternatives for neuropsychiatric disorders.
Transcranial electrical stimulation (tES) systems are becoming more deployable.
Mobile-Health technologies can enhance clinical trial accessibility and equity.

Purpose of the Study:

To discuss the implementation of tES digital trials.
To evaluate methodological aspects of tES digital trial designs.
To provide Delphi-based recommendations for tES digital trial implementation.

Main Methods:

Systematic scoping review and strategic process mapping.
Convened 61 specialists and contacted 8 tES companies.
Assessed 71 issues regarding tES digitalization readiness, processes, barriers, advantages, and opportunities.
Provided Delphi-based recommendations with >60% agreement.

Main Results:

Key strengths of tES include its non-pharmacological nature (92%), safety (80%), affordability (88%), and scalability (78%).
Weaknesses include insufficient supervision (76%) and unclear regulatory status (69%).
Device appraisal indicated moderate digitalization readiness, high safety, and trial potential, but low connectivity.

Conclusions:

tES holds potential for scalability and generalizability within digital trials.
No consensus was reached on methodological biases in tES digital trials.
A conceptual framework is proposed for integrating mobile-Health tES technologies with digital trial methodologies.