Highlights
- •Illustrated that limited output tES devices have specifications that are below most FDA cleared devices.
- •Argued that limited output tES devices would not introduce risk if they are responsibly manufactured and legally marketed.
- •Detailed voluntary manufacturer guidance for limited output tES to minimize risks, while supporting access and innovation.
- •Outlined industry guidance that are consistent with and expand on the current regulatory standards.
- •Classified FDA product codes for more than 1200 electrical stimulators that have been FDA cleared for marketing since 1977.
Abstract
Keywords
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Brain Stimulation: Basic, Translational, and Clinical Research in NeuromodulationReferences
- Classification of methods in transcranial electrical stimulation (tES) and evolving strategy from historical approaches to contemporary innovations.J Neurosci Methods. 2013; 219: 297-311https://doi.org/10.1016/j.jneumeth.2013.07.016
- Fundamentals of transcranial electric and magnetic stimulation dose: definition, selection, and reporting practices.Brain Stimul. 2012; 5: 435-453https://doi.org/10.1016/j.brs.2011.10.001
- Rethinking the thinking cap: ethics of neural enhancement using noninvasive brain stimulation.Neurology. 2011; 76 (Epub 2011/01/12): 187-193https://doi.org/10.1212/WNL.0b013e318205d50d
- The neuroethics of non-invasive brain stimulation.Curr Biol. 2012; 22 (Epub 2012/03/01): R108-R111https://doi.org/10.1016/j.cub.2012.01.013
- The rising tide of tDCS in the media and academic literature.Neuron. 2014; 82 (Epub 2014/05/24): 731-736https://doi.org/10.1016/j.neuron.2014.05.003
- The challenge of crafting policy for do-it-yourself brain stimulation.J Med Ethics. 2013; 41 (Epub 2013/06/05): 410-412https://doi.org/10.1136/medethics-2013-101458
- Regulation of devices for cognitive enhancement.Lancet. 2013; 382 (Epub 2013/09/17): 938-939https://doi.org/10.1016/s0140-6736(13)61931-5
- Regulatory considerations for the clinical and research use of transcranial direct current stimulation (tDCS): review and recommendations from an expert panel.Clin Res Regul Aff. 2015; 32: 22-35https://doi.org/10.3109/10601333.2015.980944
- Ten common questions (and their answers) about off-label drug use.Mayo Clin Proc. 2012; 87 (Epub 2012/08/11): 982-990https://doi.org/10.1016/j.mayocp.2012.04.017
- Physicians' liability for off-label prescriptions.Hematol Oncol News Issues. 2007; 6: 24-37
Bax Global Inc v Brenneman, (Ohio Ct App 2007).
Wilkes M, Johns M. Informed Consent and Shared Decision-Making: A requirement to disclose to patients off-label prescriptions. PLoS medicine 2008;5(11):1553–1556. Epub November 11, 2008. doi: 10.1371/journal.pmed.0050223.
- Frequency-dependent electrical stimulation of the visual cortex.Curr Biol. 2008; 18 (Epub 2008/11/26): 1839-1843https://doi.org/10.1016/j.cub.2008.10.027
- Effects of transcranial direct current stimulation on working memory in patients with Parkinson's disease.J Neurol Sci. 2006; 249 (Epub 2006/07/18): 31-38https://doi.org/10.1016/j.jns.2006.05.062
- Prefrontal transcranial direct current stimulation alters activation and connectivity in cortical and subcortical reward systems: a tDCS-fMRI study.Hum Brain Mapp. 2014; 35 (Epub 2014/01/24): 3673-3686https://doi.org/10.1002/hbm.22429
- Current distribution in the brain from surface electrodes.Anesth Analg. 1968; 47 (Epub 1968/11/01): 717-723
- Gyri-precise head model of transcranial direct current stimulation: improved spatial focality using a ring electrode versus conventional rectangular pad.Brain Stimul. 2009; 2 (7.e1. Epub 2010/07/23): 201-207https://doi.org/10.1016/j.brs.2009.03.005
- Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions.Brain Stimul. 2012; 5 (Epub 2011/11/01): 175-195https://doi.org/10.1016/j.brs.2011.03.002
- The pursuit of DLPFC: non-neuronavigated methods to target the left dorsolateral pre-frontal cortex with symmetric bicephalic transcranial direct current stimulation (tDCS).Brain Stimul. 2015; 8: 590-602https://doi.org/10.1016/j.brs.2015.01.401
- Facilitation of probabilistic classification learning by transcranial direct current stimulation of the prefrontal cortex in the human.Neuropsychologia. 2004; 42 (Epub 2003/11/15): 113-117
- Safety and cognitive effect of frontal DC brain polarization in healthy individuals.Neurology. 2005; 64 (Epub 2005/03/09): 872-875https://doi.org/10.1212/01.wnl.0000152986.07469.e9
- Manipulation of phosphene thresholds by transcranial direct current stimulation in man.Exp Brain Res. 2003; 150 (Epub 2003/04/17): 375-378https://doi.org/10.1007/s00221-003-1459-8
- Retina or visual Cortex? The site of phosphene induction by transcranial alternating current stimulation.Front Integr Neurosci. 2009; 3: 6https://doi.org/10.3389/neuro.07.006.2009
- Uber subjektive Lichterscheinungen bei Reizung mit Wechselstromen.Z für Sinnesphysiol. 1935; 66: 164-181
- The site of electrical excitation of the human eye.J Physiol. 1955; 127: 189-200
- Retinal origin of phosphenes to transcranial alternating current stimulation.Clin Neurophysiol. 2010; 121 (Epub 2010/03/02): 1080-1084https://doi.org/10.1016/j.clinph.2009.10.038
Kar K, Krekelberg B. Transcranial electrical stimulation over visual cortex evokes phosphenes with a retinal origin. J Neurophysiol. 1082012. p. 2173–2178.
- Bidirectional alterations of interhemispheric parietal balance by non-invasive cortical stimulation.Brain. 2009; 132 (Epub 2009/06/17): 3011-3020https://doi.org/10.1093/brain/awp154
- Reduction of visuo-spatial neglect with vestibular galvanic stimulation.Scand J Rehabil Med. 1999; 31 (Epub 1999/06/25): 117-124
- A pragmatic analysis of the regulation of consumer transcranial direct current stimulation (TDCS) devices in the United States.J Law Biosci. 2015; 2 (Epub 2016/10/25): 669-696https://doi.org/10.1093/jlb/lsv039
List of IEC 60601 Standards 2017 [August 28, 2017]. Available from: http://www.601help.com/Other_601_Standards/other_601_standards.html.
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 EUR-Lex Access to European Union law: EUROPA; 2012 [cited 2017 02/09/17]. Available from: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52012PC0542.
- Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research.Clin Neurophysiol. 2009; 120 (Epub 2009/10/17): 2008-2039https://doi.org/10.1016/j.clinph.2009.08.016
- High-definition and non-invasive brain modulation of pain and motor dysfunction in chronic TMD.Brain Stimul. 2015; 8: 1085-1092https://doi.org/10.1016/j.brs.2015.06.008
- Cranial electrotherapy stimulation for treatment of anxiety, depression, and insomnia.Psychiatr Clin North Am. 2013; 36: 169-176https://doi.org/10.1016/j.psc.2013.01.006
- Cranial electrical stimulation improves symptoms and functional status in individuals with fibromyalgia.Pain Manag Nurs. 2013; 14 (Epub 2013/12/10): 327-335https://doi.org/10.1016/j.pmn.2011.07.002
- Effects of cranial electrotherapy stimulation on preoperative anxiety, pain and endocrine response.J Int Med Res. 2013; 41 (Epub 2013/11/23): 1788-1795https://doi.org/10.1177/0300060513500749
- Draft guidance for industry and FDA staff: class II special controls guidance document: transcutaneous electrical nerve stimulator with limited output for pain relief.U.S. Department of Health and Human Services Food and Drug Administration, Center for Devices and Radiological Health, 2010
- Draft guidance for industry and FDA staff: class II special controls guidance document: transcutaneous electrical stimulator with limited output for aesthetic purposes.U.S. Department of Health and Human Services Food and Drug Administration, Center for Devices and Radiological Health, 2010
- Safety of transcranial direct current stimulation: evidence based update 2016.Brain Stimul. 2016; 9: 641-661https://doi.org/10.1016/j.brs.2016.06.004
- Toward an operational neuroethical risk analysis and mitigation paradigm for emerging neuroscience and technology (neuroS/T).Exp Neurol. 2016; 287 (Epub 2016/10/25): 492-495https://doi.org/10.1016/j.expneurol.2016.07.016
- Remotely-supervised transcranial direct current stimulation (tDCS) for clinical trials: guidelines for technology and protocols.Front Syst Neurosci. 2015; 9: 26https://doi.org/10.3389/fnsys.2015.00026
- A protocol for the use of remotely-supervised transcranial direct current stimulation (tDCS) in multiple sclerosis (MS).J Vis Exp. 2015; 106: e53542https://doi.org/10.3791/53542
Food and Drug Administration H. Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator with Limited Output for Pain Relief - Draft Guidance for Industry and FDA Staff. In: Services USDoHaH, editor. Food and Drug Administration.
- Establishing safety limits for transcranial direct current stimulation.Clin Neurophysiol. 2009; 120: 1033-1034https://doi.org/10.1016/j.clinph.2009.03.018
- Safety and patients' satisfaction of transcutaneous supraorbital neurostimulation (tSNS) with the Cefaly(R) device in headache treatment: a survey of 2,313 headache sufferers in the general population.J Headache Pain. 2013; 14: 95https://doi.org/10.1186/1129-2377-14-95
- Use of a neuromuscular electrical stimulation device for facial muscle toning: a randomized, controlled trial.J Cosmet Dermatol. 2012; 11: 261-266
- Trigeminal nerve stimulation for epilepsy: long-term feasibility and efficacy.Neurology. 2009; 72: 936-938https://doi.org/10.1212/01.wnl.0000344181.97126.b4
- Trigeminal nerve stimulation: seminal animal and human studies for epilepsy and depression.Neurosurg Clin N Am. 2011; 22: 449-456https://doi.org/10.1016/j.nec.2011.07.001
- Trigeminal nerve stimulation in major depressive disorder: first proof of concept in an open pilot trial.Epilepsy Behav. 2011; 22: 475-478https://doi.org/10.1016/j.yebeh.2011.06.026
- Randomized controlled trial of trigeminal nerve stimulation for drug-resistant epilepsy.Neurology. 2013; 80: 786-791https://doi.org/10.1212/WNL.0b013e318285c11a
- Systematic review of parameters of stimulation, clinical trial design characteristics, and motor outcomes in non-invasive brain stimulation in stroke.Front Psychiatry. 2012; 3 (Epub 2012/11/20): 88https://doi.org/10.3389/fpsyt.2012.00088
- Targeted transcranial direct current stimulation for rehabilitation after stroke.Neuroimage. 2013; 75: 12-19https://doi.org/10.1016/j.neuroimage.2013.02.049
- Effects of non-invasive cortical stimulation on skilled motor function in chronic stroke.Brain. 2005; 128 (Epub 2005/01/07): 490-499https://doi.org/10.1093/brain/awh369
- Effects of brain polarization on reaction times and pinch force in chronic stroke.BMC Neurosci. 2006; 7 (Epub 2006/11/07): 73https://doi.org/10.1186/1471-2202-7-73
- Induction of neuroplasticity and recovery in post-stroke aphasia by non-invasive brain stimulation.Front Hum Neurosci. 2013; 7 (Epub 2014/01/09): 888https://doi.org/10.3389/fnhum.2013.00888
- Transcranial direct current stimulation for depression: 3-week, randomised, sham-controlled trial.Br J Psychiatry. 2012; 200 (Epub 2012/01/05): 52-59https://doi.org/10.1192/bjp.bp.111.097634
- The sertraline vs. electrical current therapy for treating depression clinical study: results from a factorial, randomized, controlled trial.JAMA Psychiatry. 2013; 70 (Epub 2013/02/08): 383-391https://doi.org/10.1001/2013.jamapsychiatry.32
- Therapeutic effects of non-invasive brain stimulation with direct currents (tDCS) in neuropsychiatric diseases.Neuroimage. 2014; 85 (Epub 2013/06/12): 948-960https://doi.org/10.1016/j.neuroimage.2013.05.117
- Modulation of affective symptoms and resting state activity by brain stimulation in a treatment-resistant case of obsessive-compulsive disorder.Neurocase. 2013; 19 (Epub 2012/05/05): 360-370https://doi.org/10.1080/13554794.2012.667131
- A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury.Pain. 2006; 122 (Epub 2006/03/28): 197-209https://doi.org/10.1016/j.pain.2006.02.023
- The effects of transcranial direct current stimulation in patients with neuropathic pain from spinal cord injury.Clin Neurophysiol. 2014; 126 (Epub 2014/07/17): 382-390https://doi.org/10.1016/j.clinph.2014.05.034
- Longstanding neuropathic pain after spinal cord injury is refractory to transcranial direct current stimulation: a randomized controlled trial.Pain. 2013; 154 (Epub 2013/07/09): 2178-2184https://doi.org/10.1016/j.pain.2013.06.045
- Transcranial direct current stimulation to lessen neuropathic pain after spinal cord injury: a mechanistic PET study.Neurorehabil Neural Repair. 2014; 28 (Epub 2013/11/12): 250-259https://doi.org/10.1177/1545968313507632
- Transcranial DC stimulation coupled with TENS for the treatment of chronic pain: a preliminary study.Clin J Pain. 2009; 25 (Epub 2009/11/19): 691-695https://doi.org/10.1097/AJP.0b013e3181af1414
- tDCS-induced analgesia and electrical fields in pain-related neural networks in chronic migraine.Headache. 2012; 52: 1283-1295https://doi.org/10.1111/j.1526-4610.2012.02141.x
- Immediate effects of tDCS on the mu-opioid system of a chronic pain patient.Front Psychiatry. 2012; 3 (Epub 2012/11/07): 93https://doi.org/10.3389/fpsyt.2012.00093
- Building up analgesia in humans via the endogenous mu-opioid system by combining placebo and active tDCS: a preliminary report.PLoS One. 2014; 9: e102350https://doi.org/10.1371/journal.pone.0102350
- Noninvasive cortical modulation of experimental pain.Pain. 2012; 153 (Epub 2012/05/29): 1350-1363https://doi.org/10.1016/j.pain.2012.04.009
- Cathodal and anodal left prefrontal tDCS and the perception of control over pain.Clin J Pain. 2014; 30 (Epub 2013/11/28): 693-700https://doi.org/10.1097/ajp.0000000000000025
- Working memory training with tDCS improves behavioral and neurophysiological symptoms in pilot group with post-traumatic stress disorder (PTSD) and with poor working memory.Neurocase. 2014; (Epub 2014/03/04)https://doi.org/10.1080/13554794.2014.890727
- Feasibility of focal transcranial DC polarization with simultaneous EEG recording: preliminary assessment in healthy subjects and human epilepsy.Epilepsy Behav. 2012; 25 (Epub 2012/11/06): 417-425https://doi.org/10.1016/j.yebeh.2012.06.027
- Suppression of seizure by cathodal transcranial direct current stimulation in an epileptic patient - a case report.Ann Rehabil Med. 2011; 35 (Epub 2012/04/17): 579-582https://doi.org/10.5535/arm.2011.35.4.579
- Understanding tDCS effects in schizophrenia: a systematic review of clinical data and an integrated computation modeling analysis.Expert Rev Med Devices. 2014; 11: 383-394https://doi.org/10.1586/17434440.2014.911082
- An investigation into the effects of tDCS dose on cognitive performance over time in patients with schizophrenia.Schizophr Res. 2014; 155 (Epub 2014/04/08): 96-100https://doi.org/10.1016/j.schres.2014.03.006
- Sustained improvement of negative symptoms in schizophrenia with add-on tDCS.Clin Schizophr Relat Psychoses. 2014; (Epub 2014/06/22): 1-7https://doi.org/10.3371/csrp.jnvs.061314
- Transcranial direct current stimulation (tDCS) for the treatment of persistent visual and auditory hallucinations in schizophrenia: a case study.Brain Stimul. 2013; 6 (Epub 2013/04/23): 831-833https://doi.org/10.1016/j.brs.2013.03.003
- Modulating oscillatory brain activity correlates of behavioral inhibition using transcranial direct current stimulation.Clin Neurophysiol. 2012; 123 (Epub 2011/10/15): 979-984https://doi.org/10.1016/j.clinph.2011.09.016
- Modulating inhibitory control with direct current stimulation of the superior medial frontal cortex.Neuroimage. 2011; 56 (Epub 2011/04/05): 2249-2257https://doi.org/10.1016/j.neuroimage.2011.03.059
- Non-invasive cortical stimulation improves post-stroke attention decline.Restor Neurol Neurosci. 2009; 27 (Epub 2010/01/01): 645-650https://doi.org/10.3233/rnn-2009-0514
- Transcranial direct current stimulation effects in disorders of consciousness.Arch Phys Med Rehabil. 2014; 95 (Epub 2013/09/17): 283-289https://doi.org/10.1016/j.apmr.2013.09.002
- tDCS in patients with disorders of consciousness: sham-controlled randomized double-blind study.Neurology. 2014; 82 (Epub 2014/02/28): 1112-1118https://doi.org/10.1212/wnl.0000000000000260
- Transcranial direct current stimulation for the treatment of Parkinson's disease.J Neurol Neurosurg Psychiatry. 2010; 81 (Epub 2010/09/28): 1105-1111https://doi.org/10.1136/jnnp.2009.202556
- tDCS-enhanced motor and cognitive function in neurological diseases.Neuroimage. 2014; 85 (Epub 2013/06/04): 934-947https://doi.org/10.1016/j.neuroimage.2013.05.098
- Noninvasive cortical stimulation with transcranial direct current stimulation in Parkinson's disease.Mov Disord. 2006; 21 (Epub 2006/07/04): 1693-1702https://doi.org/10.1002/mds.21012
- Modulation of verbal fluency networks by transcranial direct current stimulation (tDCS) in Parkinson's disease.Brain Stimul. 2013; 6 (Epub 2012/03/14): 16-24https://doi.org/10.1016/j.brs.2012.01.006
- State dependent effect of transcranial direct current stimulation (tDCS) on methamphetamine craving.Int J Neuropsychopharmacol. 2014; (Epub 2014/05/16): 1-8https://doi.org/10.1017/s1461145714000686
- Diminishing risk-taking behavior by modulating activity in the prefrontal cortex: a direct current stimulation study.J Neurosci. 2007; 27 (Epub 2007/11/16): 12500-12505https://doi.org/10.1523/jneurosci.3283-07.2007
- Behavioral effects of transcranial direct current stimulation (tDCS) induced dorsolateral prefrontal cortex plasticity in alcohol dependence.J Physiol Paris. 2013; 107 (Epub 2013/07/31): 493-502https://doi.org/10.1016/j.jphysparis.2013.07.003
- A randomized controlled trial of targeted prefrontal cortex modulation with tDCS in patients with alcohol dependence.Int J Neuropsychopharmacol. 2014; 17 (Epub 2014/07/11): 1793-1803https://doi.org/10.1017/s1461145714000984
- Repeated transcranial direct current stimulation prevents abnormal behaviors associated with abstinence from chronic nicotine consumption.Neuropsychopharmacology. 2014; 39 (Epub 2013/10/25): 981-988https://doi.org/10.1038/npp.2013.298
- The off-label use, utility and potential value of tDCS in the clinical care of particular neuropsychiatric conditions.J Law Biosci. 2016; 3: 642-646https://doi.org/10.1093/jlb/lsw044
- tDCS selectively improves working memory in older adults with more education.Neurosci Lett. 2012; 521 (Epub 2012/06/12): 148-151https://doi.org/10.1016/j.neulet.2012.05.074
- Testing the limits: investigating the effect of tDCS dose on working memory enhancement in healthy controls.Neuropsychologia. 2013; 51 (Epub 2013/06/12): 1777-1784https://doi.org/10.1016/j.neuropsychologia.2013.05.018
- Transcranial direct current stimulation (tDCS) of the left dorsolateral prefrontal cortex modulates declarative memory.Brain Stimul. 2012; 5 (Epub 2011/08/16): 231-241https://doi.org/10.1016/j.brs.2011.06.007
- Improving working memory: exploring the effect of transcranial random noise stimulation and transcranial direct current stimulation on the dorsolateral prefrontal cortex.Clin Neurophysiol. 2011; 122 (Epub 2011/06/15): 2384-2389https://doi.org/10.1016/j.clinph.2011.05.009
- Transcranial direct current stimulation enhances verbal working memory training performance over time and near-transfer outcomes.J Cogn Neurosci. 2014; 26 (Epub 2014/04/20): 2443-2454https://doi.org/10.1162/jocn_a_00657
- Unleashing potential: transcranial direct current stimulation over the right posterior parietal cortex improves change detection in low-performing individuals.J Neurosci. 2012; 32 (Epub 2012/08/03): 10554-10561https://doi.org/10.1523/jneurosci.0362-12.2012
- Transcranial direct current stimulation of the prefrontal cortex modulates working memory performance: combined behavioural and electrophysiological evidence.BMC Neurosci. 2011; 12 (Epub 2011/01/08): 2https://doi.org/10.1186/1471-2202-12-2
- Increasing working memory capacity with theta transcranial alternating current stimulation (tACS).Biol Psychol. 2014; 96 (Epub 2013/12/03): 42-47https://doi.org/10.1016/j.biopsycho.2013.11.006
- Effects of transcranial direct current stimulation on consolidation of fear memory.Front Psychiatry. 2013; 4 (Epub 2013/09/27): 107https://doi.org/10.3389/fpsyt.2013.00107
- Transcranial direct current stimulation (tDCS) enhances reconsolidation of long-term memory.Brain Stimul. 2013; 6 (Epub 2012/11/10): 668-674https://doi.org/10.1016/j.brs.2012.10.007
- Transcranial electrical currents to probe EEG brain rhythms and memory consolidation during sleep in humans.PLoS One. 2011; 6 (Epub 2011/02/23): e16905https://doi.org/10.1371/journal.pone.0016905
- Transcranial direct current stimulation during sleep improves declarative memory.J Neurosci. 2004; 24 (Epub 2004/11/05): 9985-9992https://doi.org/10.1523/jneurosci.2725-04.2004
- Use of transcranial direct current stimulation (tDCS) to enhance cognitive training: effect of timing of stimulation.Exp Brain Res. 2014; 232 (Epub 2014/07/06): 3345-3351https://doi.org/10.1007/s00221-014-4022-x
- A comparison of the effects of transcranial direct current stimulation and caffeine on vigilance and cognitive performance during extended wakefulness.Brain Stimul. 2014; 7 (Epub 2014/07/23): 499-507https://doi.org/10.1016/j.brs.2014.04.008
- Enhancing vigilance in operators with prefrontal cortex transcranial direct current stimulation (tDCS).Neuroimage. 2014; 85 (Epub 2012/12/14): 909-917https://doi.org/10.1016/j.neuroimage.2012.11.061
- Facilitate insight by non-invasive brain stimulation.PLoS One. 2011; 6 (Epub 2011/02/12): e16655https://doi.org/10.1371/journal.pone.0016655
- Brain stimulation enables the solution of an inherently difficult problem.Neurosci Lett. 2012; 515 (Epub 2012/03/24): 121-124https://doi.org/10.1016/j.neulet.2012.03.012
- Noninvasive transcranial direct current stimulation over the left prefrontal cortex facilitates cognitive flexibility in tool use.Cogn Neurosci. 2013; 4: 81-89https://doi.org/10.1080/17588928.2013.768221
- Space, time, and causality in the human brain.Neuroimage. 2014; 92: 285-297https://doi.org/10.1016/j.neuroimage.2014.02.015
- Transcranial direct current stimulation over Broca's region improves phonemic and semantic fluency in healthy individuals.Neuroscience. 2011; 183 (Epub 2011/04/12): 64-70https://doi.org/10.1016/j.neuroscience.2011.03.058
- Electrical stimulation of Broca's area enhances implicit learning of an artificial grammar.J Cogn Neurosci. 2010; 22 (Epub 2009/11/21): 2427-2436https://doi.org/10.1162/jocn.2009.21385
- Transcranial direct current stimulation improves word retrieval in healthy and nonfluent aphasic subjects.J Cogn Neurosci. 2011; 23 (Epub 2010/10/16): 2309-2323https://doi.org/10.1162/jocn.2010.21579
- Short duration transcranial direct current stimulation (tDCS) modulates verbal memory.Brain Stimul. 2012; 5 (Epub 2011/10/04): 468-474https://doi.org/10.1016/j.brs.2011.08.003
- Transcranial direct current stimulation over multiple days improves learning and maintenance of a novel vocabulary.Cortex. 2014; 50 (Epub 2013/08/31.): 137-147https://doi.org/10.1016/j.cortex.2013.07.013
- Left lateralizing transcranial direct current stimulation improves reading efficiency.Brain Stimul. 2012; 5: 201-207https://doi.org/10.1016/j.brs.2011.04.002
- Transcranial direct current stimulation's effect on novice versus experienced learning.Exp Brain Res. 2011; 213 (Epub 2011/06/28): 9-14https://doi.org/10.1007/s00221-011-2764-2
- Random noise stimulation improves neuroplasticity in perceptual learning.J Neurosci. 2011; 31 (Epub 2011/10/28): 15416-15423https://doi.org/10.1523/jneurosci.2002-11.2011
- Using noninvasive brain stimulation to accelerate learning and enhance human performance.Hum Factors. 2014; 56 (Epub 2014/08/22): 816-824
- Anodal transcranial direct current stimulation (tDCS) over supplementary motor area (SMA) but not pre-SMA promotes short-term visuomotor learning.Brain Stimul. 2013; 6 (Epub 2012/06/05): 101-107https://doi.org/10.1016/j.brs.2012.03.018
- Enhancing performance in numerical magnitude processing and mental arithmetic using transcranial Direct Current Stimulation (tDCS).Front Hum Neurosci. 2013; 7 (Epub 2013/06/14): 244https://doi.org/10.3389/fnhum.2013.00244
- Preliminary evidence for performance enhancement following parietal lobe stimulation in Developmental Dyscalculia.Front Hum Neurosci. 2014; 8 (Epub 2014/02/27): 38https://doi.org/10.3389/fnhum.2014.00038
- Induction of self awareness in dreams through frontal low current stimulation of gamma activity.Nat Neurosci. 2014; 17 (Epub 2014/05/13): 810-812https://doi.org/10.1038/nn.3719
- Improved isometric force endurance after transcranial direct current stimulation over the human motor cortical areas.Eur J Neurosci. 2007; 26 (Epub 2007/07/07): 242-249https://doi.org/10.1111/j.1460-9568.2007.05633.x
- Brain stimulation modulates the autonomic nervous system, rating of perceived exertion and performance during maximal exercise.Br J Sports Med. 2013; 49 (Epub 2013/03/01): 1213-1218https://doi.org/10.1136/bjsports-2012-091658
- Brain polarization enhances the formation and retention of motor memories.J Neurophysiol. 2009; 102 (Epub 2009/04/24): 294-301https://doi.org/10.1152/jn.00184.2009
- Time- but not sleep-dependent consolidation of tDCS-enhanced visuomotor skills.Cereb Cortex. 2013; 25 (Epub 2013/08/21.): 109-117https://doi.org/10.1093/cercor/bht208
- Noninvasive cortical stimulation enhances motor skill acquisition over multiple days through an effect on consolidation.Proc Natl Acad Sci U. S. A. 2009; 106 (Epub 2009/01/24): 1590-1595https://doi.org/10.1073/pnas.0805413106
- Timing-dependent priming effects of tDCS on ankle motor skill learning.Brain Res. 2014; 1581 (Epub 2014/07/27): 23-29https://doi.org/10.1016/j.brainres.2014.07.021
- Anodal transcranial direct current stimulation enhances procedural consolidation.J Neurophysiol. 2010; 104 (Epub 2010/06/12): 1134-1140https://doi.org/10.1152/jn.00661.2009
- Quantitative review finds No evidence of cognitive effects in healthy populations from single-session transcranial direct current stimulation (tDCS).Brain Stimul. 2015; 8 (Epub 02/24) (Epub 2015 Jan 16): 535-550https://doi.org/10.1016/j.brs.2015.01.400
- The uncertain outcome of prefrontal tDCS.Brain Stimul. 2014; 7: 773-783https://doi.org/10.1016/j.brs.2014.10.003
- Evidence that transcranial direct current stimulation (tDCS) generates little-to-no reliable neurophysiologic effect beyond MEP amplitude modulation in healthy human subjects: a systematic review.Neuropsychologia. 2014; 66 (Epub 12/03) (Epub 2014 Nov 20): 213-236https://doi.org/10.1016/j.neuropsychologia.2014.11.021
- Cognitive enhancement or cognitive cost: trait-specific outcomes of brain stimulation in the case of mathematics anxiety.J Neurosci. 2014; 34 (Epub 12/17): 16605-16610https://doi.org/10.1523/JNEUROSCI.3129-14.2014
- Conceptual and procedural shortcomings of the systematic review “evidence that transcranial direct current stimulation (tDCS) generates little-to-no reliable neurophysiologic effect beyond MEP amplitude modulation in healthy human subjects: a systematic review” by horvath and Co-workers.Brain Stimul. 2015; 8 (Epub 07/06) (Epub 2015 Jun 5): 846-849https://doi.org/10.1016/j.brs.2015.05.010
- Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS).Clin Neurophysiol. 2016; 128 (Epub 11/21) (Epub 2016 Oct 29): 56-92https://doi.org/10.1016/j.clinph.2016.10.087
- Systematic evaluation of the impact of stimulation intensity on neuroplastic after-effects induced by transcranial direct current stimulation.J Physiol. 2016; 595 (Epub 10/11) (Epub 2016 Nov 8): 1273-1288https://doi.org/10.1113/JP272738
- A technical guide to tDCS, and related non-invasive brain stimulation tools.Clin Neurophysiol. 2016; 127: 1031-1048https://doi.org/10.1016/j.clinph.2015.11.012
- Tolerability of repeated application of transcranial electrical stimulation with limited outputs to healthy subjects.Brain Stimul. 2016; 9: 740-754https://doi.org/10.1016/j.brs.2016.05.008
- A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation.Int J Neuropsychopharmacol. 2011; 14 (Epub 2011/02/16): 1133-1145https://doi.org/10.1017/s1461145710001690
Giordano J. Conditions for consent to the use of neurotechnology: a preparatory neuroethical approach to risk assessment and reduction: AJOB Neuroscience: Vol 6, No 4. AJOB-Neurosci 2015;6(4):12-14. Epub 11/30/2015. doi: https://doi.org/10.1080/21507740.2015.1094557.
- Toward right and good use of brain-machine interfacing neurotechnologies: ethical issues and implications for guidelines and policy.Cogn Tech J. 2011; 15: 5-10
- Neurotechnology, Evidence, and Ethics: on stewardship and the good in research and practice.Pract Pain Manag. 2010; 10: 63-69
- Draft guidance for industry and FDA staff: class II special controls guidance document: cutaneous electrode.FDA: U.S. Department of health and human Services Food and drug administration, Center for Devices and Radiological Health, 2010
- Draft guidance for industry and FDA staff: class II special controls guidance document: electroconductive media.U.S. Department of Health and Human Services Food and Drug Administration, Center for Devices and Radiological Health, 2010
- Guidance for the content of premarket submissions for software contained in medical devices.2010
- Research CfDaRHaCfBEa General principles of software validation. 2002
- Mobile medical applications guidance for industry and Food and drug administration staff.2013
- Center for Devices and Radiological Health Applying human factors and usability engineering to medical devices. 2016
- Electrical stimulation to accelerate wound healing.Diabet Foot Ankle. 2013; 4: 22081https://doi.org/10.3402/dfa.v4i0.22081
- Electric field strength and focality in electroconvulsive therapy and magnetic seizure therapy: a finite element simulation study.J Neural Eng. 2011; 8 (Epub 01/21) (Epub 2011 Jan 19): 016007https://doi.org/10.1088/1741-2560/8/1/016007
- Neural origin of evoked potentials during thalamic deep brain stimulation.J Neurophysiol. 2013; 110: 826-843https://doi.org/10.1152/jn.00074.2013
- Electric field and stimulating influence generated by deep brain stimulation of the subthalamic nucleus.Clin Neurophysiol. 2004; 115: 589-595https://doi.org/10.1016/j.clinph.2003.10.033
- Uncovering the mechanism(s) of action of deep brain stimulation: activation, inhibition, or both.Clin Neurophysiol. 2004; 115: 1239-1248https://doi.org/10.1016/j.clinph.2003.12.024
- Electric field navigated transcranial magnetic stimulation for chronic tinnitus: a pilot study.Int J Audiol. 2015; 54 (Epub 06/19) (Epub 2015 Jun 18): 899-909https://doi.org/10.3109/14992027.2015.1054041
- Electric field-navigated transcranial magnetic stimulation for chronic tinnitus: a randomized, placebo-controlled study.Int J Audiol. 2017; 56 (Epub 04/19) (Epub 2017 Apr 18): 692-700https://doi.org/10.1080/14992027.2017.1313461
- Stimulation strength and focality of electroconvulsive therapy with individualized current amplitude: a preclinical study.Conf Proc IEEE Eng Med Biol Soc. 2012; 2012: 6430-6433https://doi.org/10.1109/EMBC.2012.6347466
- Electric field characteristics of electroconvulsive therapy with individualized current amplitude: a preclinical study.Conf Proc IEEE Eng Med Biol Soc. 2013; 2013: 3082-3085https://doi.org/10.1109/EMBC.2013.6610192
- Subtype-selective electroporation of cortical interneurons.J Vis Exp. 2014; 90: e51518https://doi.org/10.3791/51518
- Application of in utero electroporation of G-protein coupled receptor (GPCR) genes, for subcellular localization of hardly identifiable GPCR in mouse cerebral cortex.Mol Cells. 2014; 37: 554-561https://doi.org/10.14348/molcells.2014.0159
U.S. Food and Drug Administration Center for Devices and Radiological Health. De Novo 510(k) Summary for Cefaly Device (K122566) 2012 [December 30, 2014]. Available from: http://www.accessdata.fda.gov/cdrh_docs/reviews/K122566.pdf.
U.S. Food and Drug Administration Center for Devices and Radiological Health. Premarket Notification 510(k) Summary for Myotrac Infiniti (K053434) 2006 [December 30, 2014]. Available from: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K053434.pdf.
U.S. Food and Drug Administration Center for Devices and Radiological Health. Premarket Notification 510(k) Summary for Sterling Medical Impulse 3 Stimulator (K121305) 2012 [December 30, 2014]. Available from: http://www.accessdata.fda.gov/cdrh_docs/pdf12/K121305.pdf.
U.S. Food and Drug Administration Center for Devices and Radiological Health. Premarket Notification 510(k) Summary for FM 10/C Cranial Electrical Nerve Stimulator (K090052) 2009 [December 30, 2014]. Available from: http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090052.pdf.
U.S. Food and Drug Administration Center for Devices and Radiological Health. Premarket Notification 510(k) Summary for HealthMate Forever Pro-8AB (K121757) 2012 [December 30, 2014]. Available from: http://www.accessdata.fda.gov/cdrh_docs/pdf12/K121757.pdf.
U.S. Food and Drug Administration Center for Devices and Radiological Health. Premarket Notification 510(k) Summary for Tanyx (K123866) 2013 [December 30, 2014]. Available from: http://www.accessdata.fda.gov/cdrh_docs/pdf12/K123866.pdf.
U.S. Food and Drug Administration Center for Devices and Radiological Health. Premarket Notification 510(k) Summary for PM3030 (K110068) 2011 [December 30, 2014]. Available from: http://www.accessdata.fda.gov/cdrh_docs/pdf11/K110068.pdf.
U.S. Food and Drug Administration Center for Devices and Radiological Health. Premarket Notification 510(k) Summary for Hi-Dow JQ-5C (K102598) 2011 [December 30, 2014]. Available from: http://www.accessdata.fda.gov/cdrh_docs/pdf10/K102598.pdf.
U.S. Food and Drug Administration Center for Devices and Radiological Health. Premarket Notification 510(k) Summary for Rejuvenique (K011935) 2001 [December 30, 2014]. Available from: http://www.accessdata.fda.gov/cdrh_docs/pdf/k011935.pdf.
U.S. Food and Drug Administration Center for Devices and Radiological Health. Premarket Notification 510(k) Summary for Nu Skin Facial Spa (K122711) 2013 [December 30, 2014]. Available from: http://www.accessdata.fda.gov/cdrh_docs/pdf12/K122711.pdf.
U.S. Food and Drug Administration Center for Devices and Radiological Health. Premarket Notification 510(k) Summary for Jiajian CMN Stimulator (K130768) 2013 [December 30, 2014]. Available from: http://www.accessdata.fda.gov/cdrh_docs/pdf13/K130768.pdf.
U.S. Food and Drug Administration Center for Devices and Radiological Health. Premarket Notification 510(k) Summary for Jiajian Electra-acupuncture Stimulators (K122812) 2013 [December 30, 2014]. Available from: http://www.accessdata.fda.gov/cdrh_docs/pdf12/K122812.pdf.
U.S. Food and Drug Administration Center for Devices and Radiological Health. Premarket Notification 510(k) Summary for NuFace Plus Device (K103472) 2010. Available from: http://www.accessdata.fda.gov/cdrh_docs/pdf10/K103472.pdf.
Empi I. Hybresis Patch Instructions for Use 2007 [Document Downloaded on December 30, 2014]. Available from: http://www.djoglobal.com/sites/default/files/360353.pdf.
Medical T. IontoPatch Overview 2013 [December 30, 2014]. Available from: http://www.iontopatch.com/index.html.
Company RAF. Fischer Model MD-2 Galvanic Unit Instruction Manual 2012 [Document Downloaded on December 30, 2014]. Available from: http://www.rafischer.com/share/md2-manual-web.pdf.
Company RAF. Fischer Model MD-1a Galvanic Unit Instruction Manual 2013 [Document Downloaded on December 30, 2014]. Available from: http://www.rafischer.com/share/md1a-manual.pdf.
Chattem I. IcyHot Smart Relief User Manual 2014 [December 30, 2014]. Available from: http://www.smartrelief.com/wp-content/uploads/2014/02/IH_SmartRelief_Inst_Manual.pdf.
Ltd B-MR. Neurotech KneeHab XP Instructions for Use 2012 [December 30, 2014]. Available from: http://www.neurotechgroup.com/library/us/downloads/Kneehab_and_Tens/US%20Kneehab+%20Controller%20IM%20Rev%202.pdf.
- Gender differences in current received during transcranial electrical stimulation.Front Psychiatry. 2014; 5: 104https://doi.org/10.3389/fpsyt.2014.00104
- Transcranial electrical brain stimulation modulates neuronal tuning curves in perception of numerosity and duration.Neuroimage. 2014; 102: 451-457https://doi.org/10.1016/j.neuroimage.2014.08.016
- Computational modeling of transcranial direct current stimulation (tDCS) in obesity: impact of head fat and dose guidelines.Neuroimage Clin. 2013; 2: 759-766https://doi.org/10.1016/j.nicl.2013.05.011