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Digitalized Transcranial Electrical Stimulation: A Consensus Statement Publisher Pubmed



Brunoni AR2, 3 ; Ekhtiari H4 ; Antal A5 ; Auvichayapat P6 ; Baeken C7, 8, 9, 10 ; Bensenor IM11 ; Bikson M12 ; Boggio P13 ; Borroni B14 ; Brighina F15 ; Brunelin J16, 17 ; Carvalho S18 ; Caumo W19, 20, 21, 22 ; Ciechanski P23 Show All Authors
Authors
  1. Brunoni AR2, 3
  2. Ekhtiari H4
  3. Antal A5
  4. Auvichayapat P6
  5. Baeken C7, 8, 9, 10
  6. Bensenor IM11
  7. Bikson M12
  8. Boggio P13
  9. Borroni B14
  10. Brighina F15
  11. Brunelin J16, 17
  12. Carvalho S18
  13. Caumo W19, 20, 21, 22
  14. Ciechanski P23
  15. Charvet L24
  16. Clark VP25
  17. Cohen Kadosh R26
  18. Cotelli M27
  19. Datta A28
  20. Deng ZD29
  21. De Raedt R30
  22. De Ridder D31
  23. Fitzgerald PB32
  24. Floel A33, 34
  25. Frohlich F35, 36, 37, 38, 39, 40
  26. George MS41, 42
  27. Ghobadiazbari P43, 44
  28. Goerigk S45, 46, 47
  29. Hamilton RH48
  30. Jaberzadeh SJ49
  31. Hoy K32
  32. Kidgell DJ50
  33. Zonoozi AK43, 51
  34. Kirton A52
  35. Laureys S53
  36. Lavidor M54
  37. Lee K55
  38. Leite J56
  39. Lisanby SH29
  40. Loo C57, 58
  41. Martin DM57, 58
  42. Miniussi C59
  43. Mondino M15, 16
  44. Montesilva K60, 61
  45. Moralesquezada L62
  46. Nitsche MA63, 64
  47. Okano AH61, 65, 66
  48. Oliveira CS67, 68
  49. Onarheim B69
  50. Pachecobarrios K70, 71
  51. Padberg F72
  52. Nakamurapalacios EM73
  53. Palm U74, 75
  54. Paulus W76
  55. Plewnia C77
  56. Priori A78
  57. Rajji TK79, 80, 81
  58. Razza LB82
  59. Rehn EM83
  60. Ruffini G84
  61. Schellhorn K85
  62. Zarebidoky M43, 86
  63. Simis M87
  64. Skorupinski P84
  65. Suen P82
  66. Thibaut A88
  67. Valiengo LCL3
  68. Vanderhasselt MA8, 9
  69. Vanneste S89
  70. Venkatasubramanian G90
  71. Violante IR26
  72. Wexler A91
  73. Woods AJ92, 93, 94
  74. Fregni F70

Source: Clinical Neurophysiology Published:2022


Abstract

Objective: 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. The study aims are to discuss the implementation of tES digital trials by performing a systematic scoping review and strategic process mapping, evaluate methodological aspects of tES digital trial designs, and provide Delphi-based recommendations for implementing digital trials using tES. Methods: 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. Results: The main strengths/opportunities of tES were: (i) non-pharmacological nature (92% of agreement), safety of these techniques (80%), affordability (88%), and potential scalability (78%). As for weaknesses/threats, we listed insufficient supervision (76%) and unclear regulatory status (69%). Many issues related to methodological biases did not reach consensus. Device appraisal showed moderate digitalization readiness, with high safety and potential for trial implementation, but low connectivity. Conclusions: Panelists recognized the potential of tES for scalability, generalizability, and leverage of digital trials processes; with no consensus about aspects regarding methodological biases. Significance: 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. © 2022 International Federation of Clinical Neurophysiology
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