Safety and Feasibility of Transcranial Direct Current Stimulation in Pediatric Hemiparesis: Randomized Controlled Preliminary Study

Gillick, Bernadette T.; Feyma, Tim; Menk, Jeremiah; Usset, Michelle; Vaith, Amy; Wood, Teddi Jean; Worthington, Rebecca A.; Krach, Linda E.

doi:10.2522/ptj.20130565

Cited by 73 publications

(73 citation statements)

References 53 publications

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“…It was found that tDCS at 0.7 mA produced a peak brain current intensity comparable to an adult receiving 1.0 mA. This dose was subsequently applied in a bihemispheric montage in a pilot pediatric tDCS safety study in congenital hemiparesis [79]. Clinical neurophysiology in children indicated altered dose response, compared to adults, consistent with the scaling of fractional brain electric fields predicted by current flow models [84].…”

Section: Tdcs Special Consideration For Safety In Childrenmentioning

confidence: 96%

“…No serious adverse effects have been reported. tDCS has been investigated in children with a variety of diagnoses including cerebral palsy, stroke, encephalitis, epilepsy, schizophrenia and attention-deficit hyperactivity disorder [76], [77], [78], [79], [49], [61], [80], [51], [50], [81], [82], [83]. According to clinicaltrials.gov, current studies in pediatric applications of tDCS include perinatal stroke, cerebral palsy, dystonia, childhood-onset schizophrenia, attention deficit hyperactivity disorder, and autism.…”

Section: Tdcs Special Consideration For Safety In Childrenmentioning

confidence: 99%

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Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016

et al. 2016

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This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, and limited to, the absence of evidence for a Serious Adverse Effect, the criteria for which are rigorously defined. This review adopts an evidence-based approach, based on an aggregation of experience from human trials, taking care not to confuse speculation on potential hazards or lack of data to refute such speculation with evidence for risk. Safety data from animal tests for tissue damage are reviewed with systematic consideration of translation to humans. Arbitrary safety considerations are avoided. Computational models are used to relate dose to brain exposure in humans and animals. We review relevant dose-response curves and dose metrics (e.g. current, duration, current density, charge, charge density) for meaningful safety standards. Special consideration is given to theoretically vulnerable populations including children and the elderly, subjects with mood disorders, epilepsy, stroke, implants, and home users. Evidence from relevant animal models indicates that brain injury by Direct Current Stimulation (DCS) occurs at predicted brain current densities (6.3–13 A/m2) that are over an order of magnitude above those produced by conventional tDCS. To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 mA, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions and 1,000 subjects with repeated sessions. This includes a wide variety of subjects, including persons from potentially vulnerable populations.

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Section: Tdcs Special Consideration For Safety In Childrenmentioning

confidence: 96%

Section: Tdcs Special Consideration For Safety In Childrenmentioning

confidence: 99%

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016

et al. 2016

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“…The impact of tDCS on symptoms of cerebral palsy and dystonia has been investigated by a few studies in children and adolescents. Most published studies report some clinical improvements without important adverse effects (Grecco et al, 2013(Grecco et al, , 2014aYoung et al, 2013Young et al, , 2014Duarte et al, 2014;Gillick et al, 2014Gillick et al, , 2015aCollange Grecco et al, 2015), with one exception that will be mentioned in the discussion section (Ekici, 2015). A null effect was also reported in one case ( Bhanpuri et al, 2015).…”

Section: Cerebral Palsy and Dystoniamentioning

confidence: 98%

Applications of transcranial direct current stimulation in children and pediatrics

Rivera-Urbina¹,

Nitsche

Vicario

et al. 2017

Reviews in the Neurosciences

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AbstractTranscranial direct current stimulation (tDCS) is a neuromodulatory noninvasive brain stimulation tool with potential to increase or reduce regional and remote cortical excitability. Numerous studies have shown the ability of this technique to induce neuroplasticity and to modulate cognition and behavior in adults. Clinical studies have also demonstrated the ability of tDCS to induce therapeutic effects in several central nervous system disorders. However, knowledge about its ability to modulate brain functions in children or induce clinical improvements in pediatrics is limited. The objective of this review is to describe relevant data of some recent studies that may help to understand the potential of this technique in children with specific regard to effective and safe treatment of different developmental disorders in pediatrics. Overall, the results show that standard protocols of tDCS are well tolerated by children and have promising clinical effects. Nevertheless, treatment effects seem to be partially heterogeneous, and a case of a seizure in a child with previous history of infantile spasms and diagnosed epilepsy treated with tDCS for spasticity was reported. Further research is needed to determine safety criteria for tDCS use in children and to elucidate the particular neurophysiological changes induced by this neuromodulatory technique when it is applied in the developing brain.

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“…Safety in neuromodulation studies has been measured through lack of declining performance and reports of both serious (seizure) and minor (e.g., headache, tingling at the site of stimulation) adverse events (Gillick et al, 2014a(Gillick et al, , 2015Krishnan et al 2015). Short-term safety outcomes reflect risks within session or between sessions across the study time frame with Gillick et al (2015) reporting preliminary short-term safety evidence following a 10 day trial of repetitive transcranial magnetic stimulation (rTMS) combined with CIMT (Gillick et al 2014a).…”

mentioning

confidence: 99%

“…Short-term safety outcomes reflect risks within session or between sessions across the study time frame with Gillick et al (2015) reporting preliminary short-term safety evidence following a 10 day trial of repetitive transcranial magnetic stimulation (rTMS) combined with CIMT (Gillick et al 2014a). Long-term safety outcomes reflect potential risks over time following the conclusion of the study.…”

mentioning

confidence: 99%

Repetitive Transcranial Magnetic Stimulation/Behavioral Intervention Clinical Trial: Long-Term Follow-Up of Outcomes in Congenital Hemiparesis

Rich

Menk

Krach

et al. 2016

Journal of Child and Adolescent Psychopharmacology

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Objective: The purpose of this study was to examine long-term outcomes of nonpharmacological intervention in children and adolescents with stroke utilizing repetitive transcranial magnetic stimulation (rTMS) to the primary motor cortex combined with constraint-induced movement therapy (CIMT) to improve motor function in the paretic hand. Outcome measures included function, satisfaction, and medical status review. Methods: Fourteen of the original 19 participants (74%) from our rTMS/CIMT clinical trial (real rTMS+CIMT, n = 8; and sham rTMS+CIMT, n = 6) were evaluated. The median age of the subjects at follow up was 13.4 years (range 11-20 years old, 50% male). Median time to follow-up was 47.5 months (range 21-57 months). Descriptive statistics were conducted using frequencies and counts. Motor performance was measured using the Assisting Hand Assessment (AHA) and Canadian Occupational Performance Measure (COPM). Satisfaction was reported with use of the COPM and TMS Tolerance Survey. Open-ended interview was conducted for feedback on study experience and subjective perspectives of current functional status. Results: Overall, seven of eight individuals who received real rTMS and five of six individuals who received sham rTMS maintained or improved AHA scores. Six of 14 participants reported new onset of co-occurring conditions (four individuals in the real rTMS group, two individuals in the sham rTMS group). The majority (86%) of participants reported study satisfaction. Review of medical status revealed co-occurring conditions including: Epilepsy, obsessive-compulsive disorder, anxiety, depression, unspecified mood disorder, and undiagnosed inattentiveness. Conclusions: Long-term outcomes of rTMS/CIMT in pediatric stroke were investigated. Variability in performance and unattributed symptoms were noted. Considering the prevalence of co-occurring conditions in children and adolescents with stroke, new-onset symptoms were not attributed to original intervention. With the small sample size, the impact of rTMS on long-term outcomes cannot be fully determined from these data. Characterizing long-term outcomes through performance, participant perspectives, and medical status allows comprehensive assessment of rTMS/CIMT intervention efficacy.

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Safety and Feasibility of Transcranial Direct Current Stimulation in Pediatric Hemiparesis: Randomized Controlled Preliminary Study

Cited by 73 publications

References 53 publications

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016

Applications of transcranial direct current stimulation in children and pediatrics

Repetitive Transcranial Magnetic Stimulation/Behavioral Intervention Clinical Trial: Long-Term Follow-Up of Outcomes in Congenital Hemiparesis

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