Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul

Department of Neurosciences and Behavior, Institute of Psychology, University of São Paulo, São Paulo, Brazil.
Brain Stimulation (Impact Factor: 4.4). 04/2011; 5(3):175-95. DOI: 10.1016/j.brs.2011.03.002
Source: PubMed

ABSTRACT BACKGROUND: Transcranial direct current stimulation (tDCS) is a neuromodulatory technique that delivers low-intensity, direct current to cortical areas facilitating or inhibiting spontaneous neuronal activity. In the past 10 years, tDCS physiologic mechanisms of action have been intensively investigated giving support for the investigation of its applications in clinical neuropsychiatry and rehabilitation. However, new methodologic, ethical, and regulatory issues emerge when translating the findings of preclinical and phase I studies into phase II and III clinical studies. The aim of this comprehensive review is to discuss the key challenges of this process and possible methods to address them. METHODS: We convened a workgroup of researchers in the field to review, discuss, and provide updates and key challenges of tDCS use in clinical research. MAIN FINDINGS/DISCUSSION: We reviewed several basic and clinical studies in the field and identified potential limitations, taking into account the particularities of the technique. We review and discuss the findings into four topics: (1) mechanisms of action of tDCS, parameters of use and computer-based human brain modeling investigating electric current fields and magnitude induced by tDCS; (2) methodologic aspects related to the clinical research of tDCS as divided according to study phase (ie, preclinical, phase I, phase II, and phase III studies); (3) ethical and regulatory concerns; and (4) future directions regarding novel approaches, novel devices, and future studies involving tDCS. Finally, we propose some alternative methods to facilitate clinical research on tDCS.

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Article: Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul

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    • "Stimulation of constant current is widely used in the field of non-invasive brain stimulation, with particular interest directed towards research related to the recovery of motor function after stroke, treatment of depression, chronic pain, and several neurological and psychiatric condition, as well as modulation of various cognitive function (e.g. attention, working memory) [1]. A special problem during electrical stimulation is the current regulation. "
    Dataset: ELS-3
    • "These authors found evidence of homeostatic plasticity only in a group that was given anodal tDCS over M1 in combination with another excitatory manipulation, pre-treatment with a partial N-methyl-D-aspartate receptor agonist. There has been considerable interest in the use of anodal tDCS as an adjunctive therapy to facilitate functional rehabilitation following brain injury, with some evidence that it can promote recovery of upper-limb function (reviewed by Brunoni et al., 2012; Vallar & Bolognini, 2011). Attention has been drawn recently to using action observation to promote motor rehabilitation (Sale & Franceschini, 2012; Small et al., 2012, 2013). "
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    ABSTRACT: Motor skills, including complex movement sequences, can be acquired by observing a model without physical practice of the skill, a phenomenon known as observational learning. Observational learning of motor skills engages the same memory substrate as physical practice, and is thought to be mediated by the action observation network, a bilateral fronto-parietal circuit with mirror-like properties. We examined the effects of anodal tDCS over premotor cortex, a key node of the action observation network, with on observational learning of a serial response time task. Results showed that anodal tDCS during observation of the to-be-learned sequence facilitated reaction times in the subsequent behavioral test. The study provides evidence that increasing excitability of the AON during observation can facilitate later motor skill acquisition. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
    European Journal of Neuroscience 04/2015; 41(12). DOI:10.1111/ejn.12916 · 3.18 Impact Factor
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    • "Advantages of tDCS compared to other methods of NIBS, such as transcranial magnetic stimulation (TMS), include ease-of-use, low cost, and tolerability (Vanneste et al., 2010). Using clinical grade equipment and following strict protocols with trained operators, tDCS has been tested in hundreds of clinical trials and is considered to be both safe and well-tolerated for study in a wide range of subjects (Nitsche et al., 2008; Brunoni et al., 2012b; Kalu et al., 2012). tDCS can influence sensory, motor, cognitive and psychiatric processes that could be applied directly to the treatment of common yet refractory symptoms that represent major areas of unmet treatment need, such as depressed mood, pain, fatigue, sensory and motor recovery, and cognitive impairment (Ball et al., 2002; Fregni et al., 2006; Mori et al., 2010, 2013; Andrews et al., 2011; Acler et al., 2013; Brunoni et al., 2013b; Cuypers et al., 2013; Bennabi et al., 2014), typically occurring in the context of a neurologic or psychiatric condition. "
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    ABSTRACT: The effect of transcranial direct current stimulation (tDCS) is cumulative. Treatment protocols typically require multiple consecutive sessions spanning weeks or months. However, traveling to clinic for a tDCS session can present an obstacle to subjects and their caregivers. With modified devices and headgear, tDCS treatment can be administered remotely under clinical supervision, potentially enhancing recruitment, throughput, and convenience. Here we propose standards and protocols for clinical trials utilizing remotely-supervised tDCS with the goal of providing safe, reproducible and well-tolerated stimulation therapy outside of the clinic. The recommendations include: (1) training of staff in tDCS treatment and supervision; (2) assessment of the user's capability to participate in tDCS remotely; (3) ongoing training procedures and materials including assessments of the user and/or caregiver; (4) simple and fail-safe electrode preparation techniques and tDCS headgear; (5) strict dose control for each session; (6) ongoing monitoring to quantify compliance (device preparation, electrode saturation/placement, stimulation protocol), with corresponding corrective steps as required; (7) monitoring for treatment-emergent adverse effects; (8) guidelines for discontinuation of a session and/or study participation including emergency failsafe procedures tailored to the treatment population's level of need. These guidelines are intended to provide a minimal level of methodological rigor for clinical trials seeking to apply tDCS outside a specialized treatment center. We outline indication-specific applications (Attention Deficit Hyperactivity Disorder, Depression, Multiple Sclerosis, Palliative Care) following these recommendations that support a standardized framework for evaluating the tolerability and reproducibility of remote-supervised tDCS that, once established, will allow for translation of tDCS clinical trials to a greater size and range of patient populations.
    Frontiers in Systems Neuroscience 03/2015; 9:26. DOI:10.3389/fnsys.2015.00026
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