Combination of noninvasive brain stimulation with pharmacotherapy

Abstract

Noninvasive brain stimulation (NIBS) techniques are being increasingly investigated as a therapeutic approach for neuropsychiatric disorders. One method is to combine NIBS with pharmacotherapy to enhance the clinical effects or avoid an increase in drug dosages to decrease the incidence of side effects. However, few studies to date have investigated the relative and combined efficacy of NIBS with pharmacotherapy. Based on a literature review of previous studies and meta-analyses for major depression, we identified four randomized, controlled trials that tested the combination of NIBS with a new drug and two trials that directly compared NIBS versus pharmacotherapy. There was no study designed to address the relative efficacy of each intervention against placebo and against combined therapy. We discuss the methods and rationale of NIBS-pharmacotherapy trials, addressing some methodological aspects, including factorial design, recruitment, blinding, blinding assessment, placebo effect and quantitative aspects, such as power analysis, statistics and interaction effects. Our review of the methodology underlying NIBS-drug trials provides insights for the further clinical research development of NIBS in major depression.

The Sertraline vs Electrical Current Therapy for Treating Depression Clinical Study

“…40,41 With these data, we estimated a 3-point difference effect (effect size of Cohen d=0.5) for both tDCS only and sertraline only vs placebo and a combined additive effect in the combined treatment group (ie, 6-point difference, with an effect size of Cohen d=1.0), which, considering probabilities of 5% for type I error and 20% for type II error, resulted in an estimated sample size of 30 patients per arm for a total of 120 participants (for an extensive discussion regarding our power analysis, see the articles by Brunoni et al 29,42 ). Further, we considered a difference smaller than an effect size of 0.5 or a 3-point between-group difference not to be clinically relevant per the National Institute for Clinical Excellence guidelines.…”

Transcranial direct current stimulation for the treatment of major depressive disorder: A summary of preclinical, clinical and translational findings

“…One important issue is the association of tDCS with pharmacotherapy. Pharmacological studies have shown that drugs can not only enhance but also abolish tDCS effects (Brunoni et al, 2011g;Stagg and Nitsche, 2011). Although this evidence comes from preliminary, single-session tDCS studies that stimulated the motor cortex (not the PFC) of healthy volunteers, it is important to investigate whether and which drug therapies could modify tDCS effects, specially considering that patients with MDD commonly use a plethora of medicines of different classes, such as antidepressants, anti-epileptics, antipsychotics, lithium and benzodiazepines.…”

Translational research in transcranial direct current stimulation (tDCS): a systematic review of studies in animals

“…It also seems to have additional advantages when compared with transcranial magnetic stimulation (TMS): in particular, tDCS is relatively more portable, affordable, tolerable and, perhaps, also safer Zaghi et al , 2009 ;Brunoni et al , 2011a ). Furthermore, tDCS can be combined with pharmacotherapy to enhance its clinical effects and/or reduce adverse effects by avoiding drug dosage increases (Brunoni et al , 2011c ).…”