new research in lancet found that transcranial direct current stimulation (tDCS) was comparable to placebo (sham treatment) for depression. As a multicenter, sham-controlled, triple-blind study, this was a well-designed study and the results should be considered robust.
The study was carried out by a large team of German researchers led by Gerrit Burckhardt at the Ludwig-Maximilians-Universität Munich in Munich, Germany.
According to researchers,
“Active tDCS was not superior to sham stimulation over the 6-week period. Our trial does not support the efficacy of tDCS as an add-on treatment to SSRIs in adult patients with MDD.”
tDCS is one of several controversial brain stimulation or “neuromodulation” devices, including transcranial magnetic stimulation (TMS). TMS uses a large machine to deliver electrical pulses to the brain, while tDCS is a smaller device that delivers a constant, low current to the brain.
TMS is FDA-approved for the treatment of depression and OCD, but tDCS is not FDA-approved for any indication. tDCS devices are sometimes purchased online and used at home by people who call themselves “biohackers.” However, websites usually include a warning that users should not use them for personal “medical purposes”.
The study involved 150 people with moderate depression on average. All participants had ‘treatment-resistant’ depression. This means that at least one SSRI failed to improve depression in this study. The study continued to use ineffective drugs throughout treatment.
The aim of this trial was to determine whether tDCS as an adjunct to ineffective SSRI treatment leads to improvements in depression rating scales.
Only about 7% of the participants had tried psychotherapy.
In this study, 77 participants received tDCS and 73 participants received sham treatment, a sham version of tDCS designed to look like the real thing. Participants received daily treatment sessions for 4 weeks, plus 2 additional sessions per week for 2 weeks (6 weeks total treatment).
The study was performed in a triple-blind fashion, and no participant knew whether participants were receiving real or sham tDCS. The study has also been conducted at his eight different hospitals in Germany, which helps give real-world validity to the results (although we know that the results were not guided by the experience of a single center). (because there is).
There were no differences in improvement in any outcome between the two groups at 6 weeks, including the primary outcome of the MADRS depression scale and the secondary outcomes of the BDI-II, CGI-S, GAF, SF-36 and SHAPS. -D, STAI score. This was also true at both 18 and 30 weeks of follow-up.
More people in the placebo group improved in remission (no depression) within 6 weeks, 38% vs. 31% (this difference was not statistically significant). In other words, about one-third of people with moderate “treatment-resistant” depression cleared their depression within six weeks, regardless of whether they were receiving treatment. This was despite continuing a treatment that had already been evaluated as ineffective (SSRI). before starting research.
Although tDCS was ineffective in treating depression, it was worrisomely associated with some adverse effects, including increased self-harm.
“The active group had higher rates of headaches, sleep-related problems, local reactions at the treatment site (such as burning and skin irritation), restlessness, nausea, hallucinations and self-harm,” the researchers said. wrote.
60% of patients who received tDCS experienced side effects, compared to 43% who reported side effects in the sham group.
Despite the invalid results, the researchers wrote:
“Future research will focus on advancing our neurobiological understanding of the effects of tDCS on symptoms of depression and incorporating technology development to establish personalized tDCS as an alternative to so-called one-size-fits-all approaches. should be given.”
The statement called for research on the putative “effect of tDCS on depressive symptoms” and “establishing an individualized tDCS,” even though the treatment was found not to be superior to placebo. and may be explained by long-standing financial conflicts of interest. By many researchers involved. Some products are funded by brain stimulation companies such as Neuromod and Brainsway, as well as many other pharmaceutical and device companies. Some have been provided with unspecified brain stimulators from these companies, the price of which can run into the hundreds of thousands of dollars (although his tDCS device in particular is relatively inexpensive). At least one of his investigators in this study has a patent pending for a brain stimulator and serves as Executive Chairman of the German Psychiatric and Brain Stimulation Society.
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Burkhardt, G., Kumpf, U., Crispin, A., Goerigk, S., Andre, E., Plewnia, C., . . & Padberg, F. (2023). Transcranial direct current stimulation (DepressionDC) as an add-on treatment to selective serotonin reuptake inhibitors in adults with major depressive disorder in Germany: a triple-blind, randomized, sham-controlled, multicenter trial. lancet. Published online on July 3, 2023. https://doi.org/10.1016/S0140-6736(23)00640-2 (Link)
