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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
Show Affiliations
Authors Affiliations
  1. 1. Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil
  2. 2. Department of Internal Medicine, Faculdade de Medicina da Universidade de Sao Paulo & Hospital Universitario, Universidade de Sao Paulo, Sao Paulo, Brazil
  3. 3. 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 Sao Paulo, Sao Paulo, Brazil
  4. 4. Laureate Institute for Brain Research (LIBR), Tulsa, OK, United States
  5. 5. Department of Neurology, University Medical Center Gottingen, Gottingen, Germany
  6. 6. Department of Physiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
  7. 7. Vrije Universiteit Brussel (VUB): Department of Psychiatry University Hospital (UZBrussel), Brussels, Belgium
  8. 8. Department of Head and Skin, Ghent University Hospital, Ghent University, Ghent, Belgium
  9. 9. Ghent Experimental Psychiatry (GHEP) Lab, Ghent, Belgium
  10. 10. Eindhoven University of Technology, Department of Electrical Engineering, Netherlands
  11. 11. Center for Clinical and Epidemiological Research, University of Sao Paulo, Sao Paulo, Brazil
  12. 12. The Department of Biomedical Engineering, The City College of New York, The City University of New York, NY, United States
  13. 13. Social and Cognitive Neuroscience Laboratory, Center for Biological Science and Health, Mackenzie Presbyterian University, Sao Paulo, Brazil
  14. 14. Centre for Neurodegenerative Disorders, Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Italy
  15. 15. Department of Biomedicine, Neuroscience and Advanced Diagnostics (Bi.N.D.), University of Palermo, Palermo, Italy
  16. 16. Centre Hospitalier le Vinatier, Bron, France
  17. 17. INSERM U1028, CNRS UMR 5292, PSYR2 Team, Centre de recherche en Neurosciences de Lyon (CRNL), Universite Lyon 1, Lyon, France
  18. 18. Translational Neuropsychology Lab, Department of Education and Psychology and William James Center for Research (WJCR), University of Aveiro, Campus Universitario de Santiago, Aveiro, Portugal
  19. 19. Post-Graduate Program in Medical Sciences, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Brazil
  20. 20. Laboratory of Pain and Neuromodulation at Hospital de Clinicas de Porto Alegre (HCPA), Porto Alegre, Brazil
  21. 21. Pain and Palliative Care Service at HCPA, Brazil
  22. 22. Department of Surgery, School of Medicine, UFRGS, Brazil
  23. 23. Faculty of Medicine and Dentistry, University of Alberta, 1-002 Katz Group Centre for Pharmacy and Health Research, Edmonton, AB, Canada
  24. 24. Department of Neurology, NYU Grossman School of Medicine, New York, NY, United States
  25. 25. Psychology Clinical Neuroscience Center, Department of Psychology, The University of New Mexico, Albuquerque, NM, United States
  26. 26. School of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, United Kingdom
  27. 27. Neuropsychology Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
  28. 28. Research and Development, Soterix Medical Inc., New York, United States
  29. 29. Noninvasive Neuromodulation Unit, Experimental Therapeutics & Pathophysiology Branch, National Institute of Mental Health, Bethesda, MD, United States
  30. 30. Department of Experimental Clinical and Health Psychology, Ghent University, Belgium
  31. 31. Section of Neurosurgery, Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand
  32. 32. Epworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash University, Department of Psychiatry, Camberwell, VIC, Australia
  33. 33. Department of Neurology, University Medicine Greifswald, Greifswald, Germany
  34. 34. German Center for Neurodegenerative Diseases (DZNE), Rostock/Greifswald, Germany
  35. 35. Department of Psychiatry, University of North Carolina, Chapel Hill, NC, United States
  36. 36. Carolina Center for Neurostimulation, University of North Carolina, Chapel Hill, NC, United States
  37. 37. Neuroscience Center, University of North Carolina, Chapel Hill, NC, United States
  38. 38. Department of Cell Biology and Physiology, University of North Carolina, Chapel Hill, NC, United States
  39. 39. Department of Biomedical Engineering, University of North Carolina, Chapel Hill, NC, United States
  40. 40. Department of Neurology, University of North Carolina, Chapel Hill, NC, United States
  41. 41. Department of Psychiatry, Medical University of South Carolina, Charleston, SC, United States
  42. 42. Ralph H. Johnson VA Medical Center, Charleston, SC, United States
  43. 43. Iranian National Center for Addiction Studies, Tehran University of Medical Sciences, Tehran, Iran
  44. 44. Department of Biomedical Engineering, Shahed University, Tehran, Iran
  45. 45. Department of Psychiatry and Psychotherapy, LMU Hospital, Munich, Germany
  46. 46. Department of Psychological Methodology and Assessment, LMU, Munich, Germany
  47. 47. Hochschule Fresenius, University of Applied Sciences, Munich, Germany
  48. 48. Department of Neurology, University of Pennsylvania, Philadelphia, PA, United States
  49. 49. Department of Physiotherapy, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia
  50. 50. Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Science, Monash University, Melbourne, Australia
  51. 51. Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
  52. 52. Department of Clinical Neurosciences and Department of Pediatrics, University of Calgary, Calgary, AB, Canada
  53. 53. Coma Science Group, GIGA-Consciousness, GIGA Institute, University of Liege, Liege, Belgium
  54. 54. Bar Ilan University, Department of Psychology, the Gonda Brain Research Center, Israel
  55. 55. Ybrain Corporation, Gyeonggi-do, South Korea
  56. 56. INPP, Portucalense University, Porto, Portugal
  57. 57. School of Psychiatry, University of New South Wales, Sydney, NSW, Australia
  58. 58. Black Dog Institute, Sydney, NSW, Australia
  59. 59. Center for Mind/Brain Sciences – CIMeC, University of Trento, Rovereto, Italy
  60. 60. Applied Neuroscience Laboratory, Department of Physical Therapy, Universidade Federal de Pernambuco, UFPE, PE, Recife, Brazil
  61. 61. NAPeN Network (Nucleo de Assistencia e Pesquisa em Neuromodulacao), Brazil
  62. 62. Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, 02215, MA, United States
  63. 63. Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany
  64. 64. Department of Neurology, University Medical Hospital Bergmannsheil, Bochum, Germany
  65. 65. Center for Mathematics, Computation, Cognition, Universidade Federal do ABC, Sao Bernardo do Campo, Brazil
  66. 66. Brazilian Institute of Neuroscience and Neurotechnology (BRAINN/CEPID-FAPESP), University of Campinas, Sao Paulo, Campinas, Brazil
  67. 67. Master's and Doctoral Program in Health Sciences, Faculty of Medical Sciences, Santa Casa de Sao Paulo, Sao Paulo, Brazil
  68. 68. Master's and Doctoral Program in Human Movement and Rehabilitation, Evangelical University of Goias, Anapolis, Brazil
  69. 69. PlatoScience ApS, Copenhagen, Denmark
  70. 70. Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States
  71. 71. Universidad San Ignacio de Loyola, Vicerrectorado de Investigacion, Unidad de Investigacion para la Generacion y Sintesis de Evidencias en Salud, Lima, Peru
  72. 72. Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany
  73. 73. Laboratory of Cognitive Sciences and Neuropsychopharmacology, Program of Post-Graduation in Physiological Sciences, Health Sciences Center, Federal University of Espirito Santo, ES, Vitoria, Brazil
  74. 74. Department of Psychiatry and Psychotherapy, Klinikum der Universitat Munchen, Munich, Germany
  75. 75. Medical Park Chiemseeblick, Rasthausstr. 25, Bernau-Felden, 83233, Germany
  76. 76. Department of Neurology, Ludwig Maximilians University Munich, Klinikum Großhadern, Marchioninistr, Munchen, Germany
  77. 77. Department of Psychiatry and Psychotherapy, Tubingen Center for Mental Health (TuCMH), Neurophysiology and Interventional Neuropsychiatry, University of Tubingen, Tubingen, Germany
  78. 78. Aldo Ravelli Research Center for Neurotechnology and Experimental Neurotherapeutics, Department of Health Sciences, University of Milan, Milan, Italy
  79. 79. Centre for Addiction and Mental Health, Toronto, Canada
  80. 80. Temerty Faculty of Medicine, University of Toronto, Toronto, Canada
  81. 81. Toronto Dementia Research Alliance, Toronto, Canada
  82. 82. Service of Interdisciplinary Neuromodulation (SIN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil
  83. 83. Flow Neuroscience, Skane Lan, Malmo, Sweden
  84. 84. Neuroelectrics Corporation, Cambridge, MA, United States
  85. 85. neuroConn GmbH, Ilmenau, Germany
  86. 86. School of Medicine, Shahid-Sadoughi University of Medical Sciences, Yazd, Iran
  87. 87. Physical and Rehabilitation Medicine Institute, General Hospital, Medical School of the University of Sao Paulo, Sao Paulo, Brazil
  88. 88. Coma Science Group, GIGA-Consciousness & Centre du Cerveau, University and University Hospital of Liege, Liege, Belgium
  89. 89. Lab for Clinical & Integrative Neuroscience, Trinity College of Neuroscience, Trinity College Dublin, Ireland
  90. 90. Department of Psychiatry, National Institute of Mental Health and Neuro Sciences (NIMHANS), Bengaluru, India
  91. 91. Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA, United States
  92. 92. Center for Cognitive Aging and Memory, McKnight Brain Institute, University of Florida, Gainesville, FL, United States
  93. 93. Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, United States
  94. 94. Department of Neuroscience, University of Florida, Gainesville, FL, United States

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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