Examining the synergistic effects of a cognitive control video game and a home-based, self-administered non-invasive brain stimulation on alleviating depression: the DiSCoVeR trial protocol

Dechantsreiter, Esther; Padberg, Frank; Morash, Alon; Kumpf, Ulrike; Nguyen, Arthur; Menestrina, Zeno; Windel, Fabienne; Burkhardt, Gerrit; Goerigk, Stephan; Morishita, Takuya; Soldini, Aldo; Ahissar, Shira; Cohen, Tamar; Pasqualotto, Angela; Rubene, Linda; Konosonoka, Liene; Keeser, Daniel; Zill, Peter; Assi, Razan; Gardier, Rémy; Viñals, R. Roca de; Thiran, Jean‐Philippe; Segman, Ronen; Benjamini, Yuval; Bonne, Omer; Hummel, Friedhelm; Bavelier, Daphné; Rancāns, Elmārs; Nahum, Mor

doi:10.1007/s00406-022-01464-y

Cited by 10 publications

(8 citation statements)

References 110 publications

(135 reference statements)

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“…Another protocol describes a parallel-group RCT (double-active vs double-placebo), combining home-based tDCS and cognitive control training in the treatment of 114 MDD patients. In addition to investigating the synergy of tDCS and mini games for cognitive control training, an interesting aspect of this study is the implementation of an electrode-positioning algorithm that allows the correct positioning of the electrode cap even during self-application at home [ 21 ]. Another protocol describes a large RCT with 210 patients and three arms (70 each), where home-based tDCS is investigated in conjunction with internet-based behavioural therapy (iBT) [ 42 ].…”

Section: Resultsmentioning

confidence: 99%

“… The combination of tDCS with other interventions could also be tested in the home-based setting. This is expected to have a synergistic effect, feasibly improving the rather small effects of tDCS compared to placebo [ 21 ]. A RCT examining the combined effects of tDCS and behavioural therapy in a clinical group setting had negative results, however this study lacked a double-placebo condition [ 59 ].…”

Section: Discussionmentioning

confidence: 99%

“…In addition, combination with digital interventions (e.g. gamified training) is possible [ 21 ]. So far, tDCS as a home-based treatment has been investigated mainly in the fields of neurology and psychiatry.…”

Section: Introductionmentioning

confidence: 99%

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TDCS at home for depressive disorders: an updated systematic review and lessons learned from a prematurely terminated randomized controlled pilot study

Kumpf

Palm²,

Eder

et al. 2023

Eur Arch Psychiatry Clin Neurosci

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The application of transcranial direct current stimulation (tDCS) at home for the treatment of major depressive disorder (MDD) is the subject of current clinical trials. This is due to its positive safety profile, cost-effectiveness, and potential scalability for a wide outreach in clinical practice. Here, we provide a systematic review of the available studies and also a report on the results of a randomized controlled trial (RCT) on tDCS at home for the treatment of MDD. This trial had to be prematurely terminated due to safety concerns. The HomeDC trial is a double-blinded, placebo-controlled, parallel-group study. Patients with MDD (DSM-5) were randomized to active or sham tDCS. Patients conducted tDCS at home for 6 weeks with 5 sessions/week (30 min at 2 mA) anode over F3, cathode over F4. Sham tDCS resembled active tDCS, with ramp-in and ramp-out periods, but without intermittent stimulation. The study was prematurely terminated due to an accumulation of adverse events (AEs, skin lesions), so that only 11 patients were included. Feasibility was good. Safety monitoring was not sufficient enough to detect or prevent AEs within an appropriate timeframe. Regarding antidepressant effects, the reduction in depression scales over time was significant. However, active tDCS was not superior to sham tDCS in this regard. Both the conclusions from this review and the HomeDC trial show that there are several critical issues with the use of tDCS at home that need to be addressed. Nevertheless the array of transcranial electric simulation (TES) methods that this mode of application offers, including tDCS, is highly interesting and warrants further investigation in high quality RCTs. Trial registration: www.clinicaltrials.gov. Trial registration number: NCT05172505. Registration date: 12/13/2021, https://clinicaltrials.gov/ct2/show/NCT05172505. Graphical abstract *Consider, if feasible to do so, reporting the number of records identified from each database or register searched (rather than the total number across all databases/registers) **If automation tools were used, indicate how many records were excluded by a human and how many were excluded by automation tools From: Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. https://doi.org/10.1136/bmj.n71. For more information, visit: http://www.prisma-statement.org/

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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TDCS at home for depressive disorders: an updated systematic review and lessons learned from a prematurely terminated randomized controlled pilot study

Kumpf

Palm²,

Eder

et al. 2023

Eur Arch Psychiatry Clin Neurosci

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“…The use of cognitive tasks with rTMS is more limited, but not impossible as demonstrated in recent studies. 37,38 On the other hand, rTMS produces effects of greater magnitude. We believe that the best results are obtained with NIBS associated with cognitive tasks during or after NIBS.…”

Section: Discussionmentioning

confidence: 99%

Non-invasive brain stimulation in craving disorders: evidence-based umbrella review

Sá,

Goulardins,

Sá

et al. 2023

Brain Imaging and Stimul.

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INTRODUCTION: The use of brain stimulation in the control of craving disorders is controversial, mainly in relation to the best target, technique, duration, frequency and parameters. Several meta-analyses have been published, and their data should be summarized to support the best evidence-based clinical practice. OBJECTIVE: To provide the best level of evidence for the use of non-invasive brain stimulation (NIBS) in the control of craving disorders. METHODS: Umbrella review registraded on Prospero (CRD42021239577), and conducted according to PRISMA recommendations. The methodological quality and evidence level were assessed through AMSTAR, AMSTAR rank and GRADE. RESULTS: A total of 81 meta-analyses were screened and the final analysis was made on 10 studies including 224 randomized clinical trials (RCTs) enrolling 5,555 patients. The main targets of stimulation were the right, left and bi-hemispheric dorsolateral prefrontal cortices. The studies used anodal tDCS, and high-frequency rTMS. The protocols with the larger effect sizes were anodal tDCS with 2mA, for 30 minutes over the right DLPFC (g=0.45; 95%CI 0.328-0.583; p<0.001), and high-frequency rTMS (10Hz), with 100% of the resting motor threshold, over the left DLPFC (g=1.116; 95%CI 0.597-1.634; p<0.001). The quality of evidence ranged from very low to moderate because of inconsistencies mainly due to sample heterogeneity. CONCLUSION: The results of 10 meta-analyses assessing the efficacy of NIBS in the control of craving disorders are robust regarding the effect sizes and provide evidence that bi-hemispheric tDCS and high-frequency rTMS over the DLPFC are effective in the control of craving disorders. However, the evidence level is from low to moderate.

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“…Antidepressant effects were promising and long lasting with 91.3% clinical response and 73.9% remission rates even in the 6-month follow up (28). In addition to the results of these pilot studies, case reports, and smaller monocentric single blinded trials, study protocols of larger RCTs on this topic even with the combination of tDCS with cognitive training or behavioural therapy have been published, though the results of these trials are expected in the future (29,30).…”

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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Examining the synergistic effects of a cognitive control video game and a home-based, self-administered non-invasive brain stimulation on alleviating depression: the DiSCoVeR trial protocol

Cited by 10 publications

References 110 publications

TDCS at home for depressive disorders: an updated systematic review and lessons learned from a prematurely terminated randomized controlled pilot study

TDCS at home for depressive disorders: an updated systematic review and lessons learned from a prematurely terminated randomized controlled pilot study

Non-invasive brain stimulation in craving disorders: evidence-based umbrella review

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

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