Brain Stimul
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We present device standards for low-power non-invasive electrical brain stimulation devices classified as limited output transcranial electrical stimulation (tES). Emerging applications of limited output tES to modulate brain function span techniques to stimulate brain or nerve structures, including transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), and transcranial pulsed current stimulation (tPCS), have engendered discussion on how access to technology should be regulated. In regards to legal regulations and manufacturing standards for comparable technologies, a comprehensive framework already exists, including quality systems (QS), risk management, and (inter)national electrotechnical standards (IEC). ⋯ In Part 3, we develop voluntary manufacturer guidance for limited output tES that is aligned with current regulatory standards. Based on established medical engineering and scientific principles, we outline a robust and transparent technical framework for ensuring limited output tES devices are designed to minimize risks, while also supporting access and innovation. Alongside applicable medical and government activities, this voluntary industry standard (LOTES-2017) further serves an important role in supporting informed decisions by the public.
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Deep Brain Stimulation (DBS) of the subgenual cingulate cortex (SCC) is a promising therapeutic alternative to treat resistant major depressive disorder. In preclinical studies, DBS of the ventromedial prefrontal cortex (vmPFC, the rodent SCC correlate) provokes an antidepressant-like effect, along with changes in noradrenaline levels at the site of stimulation. Hence, DBS appears to activate the noradrenergic-locus coeruleus (LC) system. ⋯ DBS of the vmPFC appears to affect the LC, producing changes that may underlie its antidepressant-like effects.
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Controlled Clinical Trial
Clinical and electrophysiological outcomes of deep TMS over the medial prefrontal and anterior cingulate cortices in OCD patients.
Obsessive Compulsive Disorder (OCD) is a chronic and disabling disorder with poor response to pharmacological treatments. Converging evidences suggest that OCD patients suffer from dysfunction of the cortico-striato-thalamo-cortical (CSTC) circuit, including in the medial prefrontal cortex (mPFC) and the anterior cingulate cortex (ACC). ⋯ HF DTMS over the mPFC-ACC alleviates OCD symptoms and may be used as a novel therapeutic intervention. Notwithstanding alternative explanations, this may stem from DTMS ability to directly modify ACC activity.
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The impact of comorbid borderline personality disorder (BPD) or post-traumatic stress disorder (PTSD) on clinical and cognitive outcomes of electroconvulsive therapy (ECT) in patients with major depressive episodes (MDE) is unknown. ⋯ Despite a lower c-CGI response for inpatients with MDE + BPD, ECT is a viable treatment option for patients in the MDE + BPD/PTSD group with similar adverse cognitive effect profiles to MDE-only.
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Randomized Controlled Trial Comparative Study
Prefrontal versus motor cortex transcranial direct current stimulation (tDCS) effects on post-surgical opioid use.
Pain is often a complaint that precedes total knee arthroplasty (TKA), however the procedure itself is associated with considerable post-operative pain lasting days to weeks which can predict longer-term surgical outcomes. Previously, we reported significant opioid-sparing effects of motor cortex transcranial direct current stimulation from a single-blind trial. In the present study, we used double-blind methodology to compare motor cortex tDCS and prefrontal cortex tDCS to both sham and active-control (active electrodes over non-pain modulating brain areas) tDCS. ⋯ Results from this double-blind cortical-target-optimization study suggest that anodal transcranial direct current stimulation (tDCS) over the left prefrontal cortex may be a reasonable approach to reducing post-TKA opioid requirements. Given the unexpected finding that motor cortex failed to produce an opioid sparing effect in this follow-up trial, further research in the area of post-operative cortical stimulation is still needed.