Related Experiment Video
Updated: Aug 28, 2025
Updated Technique for Reliable, Easy, and Tolerated Transcranial Electrical Stimulation Including Transcranial Direct Current Stimulation
Published on: January 3, 2020
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.
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.
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.
