The Flow brain stimulation headset for the treatment of depression: overview of its safety, efficacy and portable design

Borrione, Lucas; Suen, Paulo; Razza, Laís B.; Santos, Leonardo Afonso dos; Sudbrack-Oliveira, Pedro; Brunoni, André R.

doi:10.1080/17434440.2020.1813565

Cited by 12 publications

(9 citation statements)

References 81 publications

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“…TDCS also has a very favourable side effect pro le with the incidence of complications from its use being low (10). The possibility of tDCS home-based treatment has been discussed for some years already, and solutions for technical requirements of its implementation have been developed and presented (11,12). Given the limitation of psychotherapy availability, as well as the current pandemic situation of COVID-19 in which frequent clinic contacts should be avoided, the concept of a treatment at home with tDCS for MDD is a reasonable option.…”

Section: Discussionmentioning

confidence: 99%

Transcranial Direct Current Stimulation as Treatment for Major Depression in a Home Treatment Setting (HomeDC Trial): Study Design and Methodology of a Double-blind, Placebo-controlled Pilotstudy

Kumpf

Ezim

Stadler

et al. 2022

Preprint

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Introduction Transcranial direct current stimulation (tDCS) of prefrontal cortex regions has been reported to exert therapeutic effects in major depressive disorder (MDD). Due to its beneficial safety profile, its easy mode of application and its cost-effectiveness, tDCS has recently been proposed for treatment at home, which would offer new chances for regionally wide spread and long-term application. However, tDCS at home has to meet new methodological challenges of handling and adherence, and data from randomized controlled trials (RCT) investigating this mode of application are still lacking. In this pilot RCT, we therefore investigate feasibility, safety and effectiveness of a new tDCS application set-up in MDD. Methods and analysis The HomeDC trial will be conducted as a double-blind, placebo-controlled, parallel-group design trial. Thirty-two patients with MDD will be randomized to active or sham tDCS. Patients will self-administer prefrontal tDCS for 6 weeks. Active tDCS will be conducted with anode over F3, cathode over F4, for 5 sessions/week, with a duration of 30min/day and 2mA stimulation intensity, whereas sham tDCS follows the identical protocol in electrode montage and timing but with ramp-in and ramp-out periods only without intermittent stimulation. Both conditions will be administered as monotherapy or adjunctive treatment to a stable dose of antidepressant medication. Feasibility, effectiveness and safety will be assessed, and adjunctive fMRI and e-field modelling will be conducted at baseline. Discussion For the HomeDC trial, technical requirements of a placebo-controlled trial in a home-based treatment setting with tDCS have been established. It addresses the crucial points of a home-based treatment approach with tDCS: uniform electrode positioning and frequent monitoring of stimulation parameters and adherence, ensuring an appropriate home treatment environment. This study will allow identifying constraints and further critical topics of this novel mode of application. Trial Registration www.clinicaltrials.gov. Trial registration number: NCT05172505. Registration date: 12/13/2021, https://clinicaltrials.gov/ct2/show/NCT05172505

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Section: Discussionmentioning

confidence: 99%

Transcranial Direct Current Stimulation as Treatment for Major Depression in a Home Treatment Setting (HomeDC Trial): Study Design and Methodology of a Double-blind, Placebo-controlled Pilotstudy

Kumpf

Ezim

Stadler

et al. 2022

Preprint

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“…advancements, such as wireless tDCS devices (Borrione et al, 2020b), make the intervention more feasible and encourage researchers to keep up efforts to investigate this approach in the neuropsychiatric field. Possibly, home-based tDCS might be an excellent option to improve depression.…”

Section: Discussionmentioning

confidence: 99%

Follow-up effects of transcranial direct current stimulation (tDCS) for the major depressive episode: A systematic review and meta-analysis

Razza

Smet

Moffa

et al. 2021

Psychiatry Research

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“…Flow app is combined with a certified tDCS medical device approved for home-use MDD treatment in adult patients (>18 years old) in the United Kingdom and the European Union. The one-size-fits-all wireless and portable tDCS headset targets the prefrontal cortex (the anode electrode over the left and the cathode electrode over the right dorsolateral prefrontal cortex; cf., Supplementary Figures 2, 3), as evidenced by electric field modeling (26). The device uses a current intensity of 2 mA, administered through two spheric electrodes of 22.9 cm² size (current density = 0.09 mA/cm²) for 30 min.…”

Section: Interventionmentioning

confidence: 99%

Home-based transcranial direct current stimulation in dual active treatments for symptoms of depression and anxiety: A case series

et al. 2022

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Transcranial direct current stimulation (tDCS) is a potential treatment strategy across some psychiatric conditions. However, there is high heterogeneity in tDCS efficacy as a stand-alone treatment. To increase its therapeutic potential, researchers have begun to explore the efficacy of combining tDCS with psychological and pharmacological interventions. The current case series details the effect of 6–10 weeks of self-administered tDCS paired with a behavioral therapy smartphone app (Flow™), on depressive and anxiety symptoms, in seven patients (26–51 years old; four female) presenting distinctive psychiatric disorders (major depression, dysthymia, illness anxiety disorder, obsessive-compulsive disorder, and anxiety disorders). tDCS protocol consisted of an acute phase of daily 30 min sessions, across 10 workdays (2 weeks Monday-to-Friday; Protocol 1) or 15 workdays (3 weeks Monday-to-Friday; Protocol 2). A maintenance phase followed, with twice-weekly sessions for 4 or 3 weeks, corresponding to 18 or 21 sessions in total (Protocol 1 or 2, respectively). The Flow tDCS device uses a 2 mA current intensity, targeting the bilateral dorsolateral prefrontal cortex. The Flow app offers virtually guided behavioral therapy courses to be completed during stimulation. We assessed depressive symptoms using MADRS-S and BDI-II, anxious symptoms using STAI-Trait, acceptability using ACCEPT-tDCS, and side effects using the Adverse Effects Questionnaire, at baseline and week 6 of treatment. Six patients underwent simultaneous cognitive-behavioral psychotherapy and two were on antidepressants and benzodiazepines. According to the Reliable Change Index (RCI), for depressive symptoms, we found clinically reliable improvement in five patients using MADRS-S (out of seven; RCI: −1.45, 80% CI; RCI: −2.17 to −4.82, 95% CI; percentage change: 37.9–66.7%) and in four patients using BDI-II (out of five; RCI: −3.61 to −6.70, 95% CI; percentage change: 57.1–100%). For anxiety symptoms, clinically reliable improvement was observed in five patients (out of six; RCI: −1.79, 90% CI; RCI: −2.55 to −8.64, 95% CI; percentage change: 12.3–46.4%). Stimulation was well-tolerated and accepted, with mild tingling sensation and scalp discomfort being the most common side effects. This case series highlights the applicability, acceptability, and promising results when combining home-based tDCS with psychotherapy and pharmacotherapy to manage depression and anxiety symptoms in clinical practice.

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The Flow brain stimulation headset for the treatment of depression: overview of its safety, efficacy and portable design

Cited by 12 publications

References 81 publications

Transcranial Direct Current Stimulation as Treatment for Major Depression in a Home Treatment Setting (HomeDC Trial): Study Design and Methodology of a Double-blind, Placebo-controlled Pilotstudy

Transcranial Direct Current Stimulation as Treatment for Major Depression in a Home Treatment Setting (HomeDC Trial): Study Design and Methodology of a Double-blind, Placebo-controlled Pilotstudy

Follow-up effects of transcranial direct current stimulation (tDCS) for the major depressive episode: A systematic review and meta-analysis

Home-based transcranial direct current stimulation in dual active treatments for symptoms of depression and anxiety: A case series

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