RESUMO
BACKGROUND: Non-invasive brain stimulation is being increasingly used to interrogate neurophysiology and modulate brain function. Despite the high scientific and therapeutic potential of non-invasive brain stimulation, experience in the developing brain has been limited. OBJECTIVE: To determine the safety and tolerability of non-invasive neurostimulation in children across diverse modalities of stimulation and pediatric populations. METHODS: A non-invasive brain stimulation program was established in 2008 at our pediatric, academic institution. Multi-disciplinary neurophysiological studies included single- and paired-pulse Transcranial Magnetic Stimulation (TMS) methods. Motor mapping employed robotic TMS. Interventional trials included repetitive TMS (rTMS) and transcranial direct current stimulation (tDCS). Standardized safety and tolerability measures were completed prospectively by all participants. RESULTS: Over 10 years, 384 children underwent brain stimulation (median 13 years, range 0.8-18.0). Populations included typical development (n = 118), perinatal stroke/cerebral palsy (n = 101), mild traumatic brain injury (n = 121) neuropsychiatric disorders (n = 37), and other (n = 7). No serious adverse events occurred. Drop-outs were rare (<1%). No seizures were reported despite >100 participants having brain injuries and/or epilepsy. Tolerability between single and paired-pulse TMS (542340 stimulations) and rTMS (3.0 million stimulations) was comparable and favourable. TMS-related headache was more common in perinatal stroke (40%) than healthy participants (13%) but was mild and self-limiting. Tolerability improved over time with side-effect frequency decreasing by >50%. Robotic TMS motor mapping was well-tolerated though neck pain was more common than with manual TMS (33% vs 3%). Across 612 tDCS sessions including 92 children, tolerability was favourable with mild itching/tingling reported in 37%. CONCLUSIONS: Standard non-invasive brain stimulation paradigms are safe and well-tolerated in children and should be considered minimal risk. Advancement of applications in the developing brain are warranted. A new and improved pediatric NIBS safety and tolerability form is included.
Assuntos
Concussão Encefálica/terapia , Epilepsia/terapia , Acidente Vascular Cerebral/terapia , Estimulação Transcraniana por Corrente Contínua/métodos , Estimulação Magnética Transcraniana/métodos , Criança , Feminino , Cefaleia/etiologia , Humanos , Masculino , Prurido/etiologia , Convulsões/etiologia , Estimulação Transcraniana por Corrente Contínua/efeitos adversos , Estimulação Magnética Transcraniana/efeitos adversosRESUMO
BACKGROUND: Changes in medical education may limit opportunities for trainees to gain proficiency in surgical skills. Transcranial direct-current stimulation (tDCS) can augment motor skill learning and may enhance surgical procedural skill acquisition. The aim of this study was to determine the effects of tDCS on simulation-based laparoscopic surgical skill acquisition. METHODS: In this double-blind, sham-controlled randomized trial, participants were randomized to receive 20 min of anodal tDCS or sham stimulation over the dominant primary motor cortex, concurrent with Fundamentals of Laparoscopic Surgery simulation-based training. Primary outcomes of laparoscopic pattern-cutting and peg transfer tasks were scored at baseline, during repeated performance over 1 h, and again at 6 weeks. Intent-to-treat analysis examined the effects of treatment group on skill acquisition and retention. RESULTS: Of 40 participants, those receiving tDCS achieved higher mean(s.d.) final pattern-cutting scores than participants in the sham group (207·6(30·0) versus 186·0(32·7) respectively; P = 0·022). Scores were unchanged at 6 weeks. Effects on peg transfer scores were not significantly different (210·2(23·5) in the tDCS group versus 201·7(18·1) in the sham group; P = 0·111); the proportion achieving predetermined proficiency levels was higher for tDCS than for sham stimulation. Procedures were well tolerated with no serious adverse events and no decreases in motor measures. CONCLUSION: The addition of tDCS to laparoscopic surgical training may enhance skill acquisition. Trials of additional skills and translation to non-simulated performance are required to determine the potential value in medical education and impact on patient outcomes. Registration number: NCT02756052 (https://clinicaltrials.gov/).