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PreprintCC BY-NC-NDmedRxiv

Accelerated high-capacity 6 mA transcranial direct current stimulation for major depression: an open-label pilot study

1 more authors
  1. 1Medical University of South Carolina

Abstract

ObjectiveHome-based 2 mA transcranial direct current stimulation (tDCS) is FDA-approved for depression, but amplitude has been limited largely by skin tolerance. This study evaluated the safety, tolerability, and feasibility of accelerated high-capacity tDCS (HC-tDCS) at 6 mA.

MethodsIn this open-label pilot study, 20 patients with major depressive disorder received 20-minute bifrontal 6 mA sessions twice daily for five days using a high-capacity stimulator and hydrogel electrodes. A Safety Review Committee reviewed data from the first three participants before the remaining 17 were enrolled.

ResultsRetention and adherence were 100% (203 of 203 sessions); 17 of 20 received 6 mA throughout, with amplitude reduced for intolerance in one and limited by an electrode fault in two. There were no serious adverse events. The most common symptoms were fatigue (49% of sessions), burning (46%) and tingling (43%) at the electrode, and difficulty concentrating (40%). Electrode-site erythema occurred in all participants, with no severe reactions. At 1 week, 7 of 20 reported a residual skin change, none painful; at 1 month, spots of residual pigmentation were observed at the electrode site in 2 participants, both Black. In five days, mean PHQ-9 scores decreased from 15.8 to 7.2 (Hedges g=1.62); 50% of participants responded, 45% remitted, and improvement was maintained at 1 month. Anhedonia, mindfulness, and self-reported cognitive function also improved (g=0.76 to 1.23), with gains maintained at 1 month.

ConclusionsAccelerated 6 mA HC-tDCS was feasible, well tolerated, and warrants a sham-controlled trial.

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BibTeX
@misc{olash2026accelerated,
  title = {{Accelerated high-capacity 6 mA transcranial direct current stimulation for major depression: an open-label pilot study}},
  author = {C. Olash and E. Collins and D. Smani and S. S. Cox and M. Bikson and K. Donnery and M. FallahRad and M. B. Koochesfahani and J.-P. Miron and C. Latham and D. Freels and J. Chasen and M. S. George},
  howpublished = {medRxiv},
  year = {2026},
  month = oct,
  doi = {10.64898/2026.10.05.26364655},
  url = {https://www.medrxiv.org/content/10.64898/2026.10.05.26364655v1},
  note = {CC BY-NC-ND},
}
RIS
TY  - UNPB
TI  - Accelerated high-capacity 6 mA transcranial direct current stimulation for major depression: an open-label pilot study
AU  - C. Olash
AU  - E. Collins
AU  - D. Smani
AU  - S. S. Cox
AU  - M. Bikson
AU  - K. Donnery
AU  - M. FallahRad
AU  - M. B. Koochesfahani
AU  - J.-P. Miron
AU  - C. Latham
AU  - D. Freels
AU  - J. Chasen
AU  - M. S. George
PY  - 2026
DA  - 2026/10/05
PB  - medRxiv
DO  - 10.64898/2026.10.05.26364655
UR  - https://www.medrxiv.org/content/10.64898/2026.10.05.26364655v1
AB  - ObjectiveHome-based 2 mA transcranial direct current stimulation (tDCS) is FDA-approved for depression, but amplitude has been limited largely by skin tolerance. This study evaluated the safety, tolerability, and feasibility of accelerated high-capacity tDCS (HC-tDCS) at 6 mA.  MethodsIn this open-label pilot study, 20 patients with major depressive disorder received 20-minute bifrontal 6 mA sessions twice daily for five days using a high-capacity stimulator and hydrogel electrodes. A Safety Review Committee reviewed data from the first three participants before the remaining 17 were enrolled.  ResultsRetention and adherence were 100% (203 of 203 sessions); 17 of 20 received 6 mA throughout, with amplitude reduced for intolerance in one and limited by an electrode fault in two. There were no serious adverse events. The most common symptoms were fatigue (49% of sessions), burning (46%) and tingling (43%) at the electrode, and difficulty concentrating (40%). Electrode-site erythema occurred in all participants, with no severe reactions. At 1 week, 7 of 20 reported a residual skin change, none painful; at 1 month, spots of residual pigmentation were observed at the electrode site in 2 participants, both Black. In five days, mean PHQ-9 scores decreased from 15.8 to 7.2 (Hedges g=1.62); 50% of participants responded, 45% remitted, and improvement was maintained at 1 month. Anhedonia, mindfulness, and self-reported cognitive function also improved (g=0.76 to 1.23), with gains maintained at 1 month.  ConclusionsAccelerated 6 mA HC-tDCS was feasible, well tolerated, and warrants a sham-controlled trial.
ER  -