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Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016

Bikson, Marom; Grossman, Pnina; Thomas, Chris; Zannou, Adantchede Louis; Jiang, Jimmy; Adnan, Tatheer; Mourdoukoutas, Antonios P; Kronberg, Greg; Truong, Dennis; Boggio, Paulo; Brunoni, Andre R; Charvet, Leigh; Fregni, Felipe; Fritsch, Brita; Gillick, Bernadette; Hamilton, Roy H; Hampstead, Benjamin M; Jankord, Ryan; Kirton, Adam; Knotkova, Helena; Liebetanz, David; Liu, Anli; Loo, Colleen; Nitsche, Michael A; Reis, Janine; Richardson, Jessica D; Rotenberg, Alexander; Turkeltaub, Peter E; Woods, Adam J
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 (
PMCID:5007190
PMID: 27372845
ISSN: 1876-4754
CID: 2225122

Transcranial Direct Current Stimulation Is Feasible for Remotely Supervised Home Delivery in Multiple Sclerosis

Kasschau, Margaret; Reisner, Jesse; Sherman, Kathleen; Bikson, Marom; Datta, Abhishek; Charvet, Leigh E
OBJECTIVES: Transcranial direct current stimulation (tDCS) has potential clinical application for symptomatic management in multiple sclerosis (MS). Repeated sessions are necessary in order to adequately evaluate a therapeutic effect. However, it is not feasible for many individuals with MS to visit clinic for treatment on a daily basis, and clinic delivery is also associated with substantial cost. We developed a research protocol to remotely supervise self- or proxy-administration for home delivery of tDCS using specially designed equipment and a telemedicine platform. MATERIALS AND METHODS: We targeted ten treatment sessions across two weeks. Twenty participants (n = 20) diagnosed with MS (any subtype), ages 30 to 69 years with a range of disability (Expanded Disability Status Scale or EDSS scores of 1.0 to 8.0) were enrolled to test the feasibility of the remotely supervised protocol. RESULTS: Protocol adherence exceeded what has been observed in studies with clinic-based treatment delivery, with all but one participant (95%) completing at least eight of the ten sessions. Across a total of 192 supervised treatment sessions, no session required discontinuation and no adverse events were reported. The most common side effects were itching/tingling at the electrode site. CONCLUSIONS: This remotely supervised tDCS protocol provides a method for safe and reliable delivery of tDCS for clinical studies in MS and expands patient access to tDCS.
PMID: 27089545
ISSN: 1525-1403
CID: 2079892

Behavioral Symptoms in Pediatric Multiple Sclerosis: Relation to Fatigue and Cognitive Impairment

Charvet, Leigh; Cersosimo, Bianca; Schwarz, Colleen; Belman, Anita; Krupp, Lauren B
The emotional and behavioral problems associated with pediatric multiple sclerosis remain unclear. Participants with pediatric multiple sclerosis or clinically isolated syndrome (n = 140; ages 5-18 years) completed self- and parent ratings using the Behavioral Assessment System for Children, Second Edition, neurologic exam, the Fatigue Severity Scale, and neuropsychological assessment. Mean self- and parent-ratings on the Behavioral Assessment System for Children, Second Edition, were in the typical range across all scales. However, 33.1% indicated a clinically significant problem on a least 1 scale. Although the type of clinical problems varied across participants, attention problems, somatization, and anxiety were found to be most common. Disease features including duration, age of onset, neurologic disability, and fatigue did not distinguish those with and without clinical problems. However, cognitive functioning significantly predicted the presence of a clinical problem (P = .02). Pediatric multiple sclerosis is associated with a range of nonspecific emotional and behavioral clinical problems, occurring more frequently in those patients with cognitive involvement.
PMCID:4925200
PMID: 26961266
ISSN: 1708-8283
CID: 2046722

[S.l. : American Psychological Society, New York, 2015]

Cognitive impairment and real-world functioning in multiple sclerosis (MS) : test of everyday cognitive ability (TECA)

Shaw, Michael; Frontario, Ariana; Kasschau, Margaret; Fang, Wendy; Sherman, Kathleen; Krupp, Lauren; Charvet, Leigh
(Website)
CID: 2238962

Assessing cognition in MS clinical trials : the cognitive assessment interview (CAI) [Meeting Abstract]

Marziliano, A; Speed, B; Cersosimo, B; Sherman, K; Shaw, M; Fang, W; Haider, L; Melville, P; Krupp, Lauren; Charvet, Leigh E
ORIGINAL:0011418
ISSN: 1526-632x
CID: 2236612

Cognition in MS across the lifespan [Meeting Abstract]

Frontario, A; Schwarz, C; Kasschau, M; Chan, J; Harel, B; Schembri, A; Amadiume, N; Krupp, Lauren; Charvet, Leigh E
ORIGINAL:0011417
ISSN: 1526-632x
CID: 2236602

Cognitive impairment is associated with behavioral problems in pediatric multiple sclerosis (MS) [Meeting Abstract]

Cersosimo, B; Schwarz, C; Gupta, N; Amadiume, N; Belman, Anita; Krupp, Lauren; Charvet, Leigh E
ORIGINAL:0011419
ISSN: 1526-632x
CID: 2236622

The Montreal Cognitive Assessment (MoCA) in Multiple Sclerosis: Relation to Clinical Features

Charvet, Leigh E; Taub, Emily; Cersosimo, Bianca; Rosicki, Christopher; Melville, Patricia; Krupp, Lauren B
ORIGINAL:0011415
ISSN: 2376-0389
CID: 2236582

Remotely-supervised cognitive remediation is feasible and effective: results of a pilot study [Meeting Abstract]

Charvet, LE; Haider, L; Shaw, M; Fang, W; Sherman, K; Melville, P; Krupp, LB
ISI:000365729401057
ISSN: 1477-0970
CID: 2225142

The Test of Everyday Cognitive Ability (TECA) Links Cognitive Measures to Real-Life Functioning in Adults with Multiple Sclerosis (MS) [Meeting Abstract]

Charvet, Leigh; Shaw, Michael; Kasschau, Margaret; Frontario, Ariana; Fang, Wendy; Sherman, Kathleen; Melville, Patricia; Krupp, Lauren
ISI:000362668600010
ISSN: 1531-8249
CID: 2225182