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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Effects of transcranial direct current stimulation on gait in people with Parkinson’s disease: study protocol for a randomized, controlled clinical trial

Authors: Vida Alizad, Marcus Meinzer, Laurent Frossard, Remco Polman, Simon Smith, Graham Kerr

Published in: Trials | Issue 1/2018

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Abstract

Background

Gait difficulties are common and frequently devastating to people with Parkinson’s disease (PD). These difficulties are often followed by an increased risk of falls, leading to injury, hospitalization and mortality. The dysfunction in the basal ganglia-thalamocortical motor circuits and reduced activity in the premotor and primary motor cortices has raised interest in transcranial direct current stimulation (tDCS) as an adjunct intervention in PD. tDCS might provide a potentially safe and non-invasive treatment by modulating cortical excitability and behavioural outcomes. The aim of this study is to compare the effects of different monopolar and bipolar montages of tDCS administered to the motor cortex and cerebellum on gait speed in PD.

Methods

This study will be conducted in a randomized, double-blind cross-over design. Eighteen participants diagnosed with Parkinson’s disease will receive anodal and sham tDCS (1 mA, 20 min, 10 × 4 cm2) over the premotor and primary motor cortices with the cathode over the cerebellum during treadmill walking. Three montages will be applied over three sessions and compared: anodal tDCS with a small active cathode (4 × 4 cm2); anodal tDCS with a large, functionally inert cathode (10 × 10 cm2); and sham tDCS. The primary outcome measure is gait speed, and secondary outcome measures include gait parameters (temporospatial, segmental, kinematic), the Timed Up and Go test and lower limb muscle activity patterns as measured by electromyography.

Discussion

This study will investigate the short-term effects of anodal tDCS over the premotor and primary motor cortices on gait abilities using monopolar and bipolar montages in people with PD. The outcomes will inform future studies aimed at inducing longer-lasting changes in neural excitability and performance using multisession tDCS designs in PD.

Trial registration

Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12618000063​213. Registered on 17 January 2018. Retrospectively registered. 
Appendix
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Literature
1.
Mirelman A, Bernad-Elazari H, Thaler A, Giladi-Yacobi E, Gurevich T, Gana-Weisz M, et al. Arm swing as a potential new prodromal marker of Parkinson's disease. Movement Disorders. 2016;31(10):1527–34.CrossRef
2.
Nutt JG, Wooten GF. Diagnosis and initial management of Parkinson's disease. N Engl J Med. 2005;353(10):1021–7.CrossRef
3.
Cole MH, Silburn PA, Wood JM, Worringham CJ, Kerr GK. Falls in Parkinson's disease: kinematic evidence for impaired head and trunk control. Movement Disorders. 2010;25(14):2369–78.CrossRef
4.
Mitoma H, Hayashi R, Yanagisawa N, Tsukagoshi H. Characteristics of parkinsonian and ataxic gaits: a study using surface electromyograms, angular displacements and floor reaction forces. J Neurol Sci. 2000;174(1):22–39.CrossRef
5.
Hiraoka K, Matsuo Y, Abe K. Soleus H-reflex inhibition during gait initiation in Parkinson's disease. Movement Disorders. 2005;20(7):858–64.CrossRef
6.
Hong M, Perlmutter JS, Earhart GM. A kinematic and electromyographic analysis of turning in people with Parkinson disease. Neurorehabil Neural Repair. 2009;23(2):166–76.CrossRef
7.
Rietdijk CD, Perez-Pardo P, Garssen J, van Wezel RJ, Kraneveld AD. Exploring Braak's hypothesis of Parkinson's disease. Front Neurol. 2017;8:37.CrossRef
8.
Buhmann C, Glauche V, Sturenburg HJ, Oechsner M, Weiller C, Buchel C. Pharmacologically modulated fMRI—cortical responsiveness to levodopa in drug-naive hemiparkinsonian patients. Brain. 2003;126(Pt 2):451–61.CrossRef
9.
Di Stasio F, Suppa A, Fabbrini A, Marsili L, Asci F, Conte A, et al. Parkinsonism is associated with altered primary motor cortex plasticity in frontotemporal dementia—primary progressive aphasia variant. Neurobiol Aging. 2018;69:230–8.CrossRef
10.
Martinu K, Monchi O. Cortico-basal ganglia and cortico-cerebellar circuits in Parkinson's disease: pathophysiology or compensation? Behav Neurosci. 2013;127(2):222–36.CrossRef
11.
Wu T, Hallett M. The cerebellum in Parkinson’s disease. Brain. 2013;136(3):696–709.CrossRef
12.
Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000;527(Pt 3):633–9.CrossRef
13.
Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001;57(10):1899–901.CrossRef
14.
Daskalakis ZJ, Paradiso GO, Christensen BK, Fitzgerald PB, Gunraj C, Chen R. Exploring the connectivity between the cerebellum and motor cortex in humans. J Physiol. 2004;557(Pt 2):689–700.CrossRef
15.
Miniussi C, Harris JA, Ruzzoli M. Modelling non-invasive brain stimulation in cognitive neuroscience. Neurosci Biobehav Rev. 2013;37(8):1702–12.CrossRef
16.
Perceval G, Floel A, Meinzer M. Can transcranial direct current stimulation counteract age-associated functional impairment? Neurosci Biobehav Rev. 2016;65:157–72.CrossRef
17.
Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, et al. Safety of transcranial direct current stimulation: evidence based update 2016. Brain Stimulation. 2016;9(5):641–61.CrossRef
18.
Fregni F, Nitsche MA, Loo CK, Brunoni AR, Marangolo P, Leite J, et al. 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(1):22–35.CrossRef
19.
Stagg CJ, Nitsche MA. Physiological basis of transcranial direct current stimulation. Neuroscientist. 2011;17(1):37–53.CrossRef
20.
Fertonani A, Miniussi C. Transcranial electrical stimulation: what we know and do not know about mechanisms. Neuroscientist. 2016;23(2):109–23.CrossRef
21.
Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, et al. Transcranial direct current stimulation: state of the art 2008. Brain Stimulation. 2008;1(3):206–23.CrossRef
22.
Schulz R, Gerloff C, Hummel FC. Non-invasive brain stimulation in neurological diseases. Neuropharmacology. 2013;64:579–87.CrossRef
23.
Ferrucci R, Mameli F, Ruggiero F, Priori A. Transcranial direct current stimulation as treatment for Parkinson’s disease and other movement disorders. Basal Ganglia. 2016;6(1):53–61.CrossRef
24.
Costa-Ribeiro A, Maux A, Bosford T, Aoki Y, Castro R, Baltar A, et al. Transcranial direct current stimulation associated with gait training in Parkinson's disease: a pilot randomized clinical trial. Developmental Neurorehabil. 2017;20(3):121–8.CrossRef
25.
Costa-Ribeiro A, Maux A, Bosford T, Tenorio Y, Marques D, Carneiro M, et al. Dopamine-independent effects of combining transcranial direct current stimulation with cued gait training on cortical excitability and functional mobility in Parkinson's disease. J Rehabil Med. 2016;48(9):819–23.CrossRef
26.
Schabrun SM, Lamont RM, Brauer SG. Transcranial direct current stimulation to enhance dual-task gait training in Parkinson's disease: a pilot RCT. PLOS One. 2016;11(6):e0158497.CrossRef
27.
von Papen M, Fisse M, Sarfeld AS, Fink GR, Nowak DA. The effects of 1 Hz rTMS preconditioned by tDCS on gait kinematics in Parkinson's disease. J Neural Transm. 2014;121(7):743–54.CrossRef
28.
Benninger DH, Lomarev M, Lopez G, Wassermann EM, Li X, Considine E, et al. Transcranial direct current stimulation for the treatment of Parkinson's disease. J Neurol Neurosurg Psychiatry. 2010;81(10):1105–11.CrossRef
29.
Valentino F, Cosentino G, Brighina F, Pozzi NG, Sandrini G, Fierro B, et al. Transcranial direct current stimulation for treatment of freezing of gait: a cross-over study. Movement Disorders. 2014;29(8):1064–9.CrossRef
30.
Kaski D, Dominguez RO, Allum JH, Islam AF, Bronstein AM. Combining physical training with transcranial direct current stimulation to improve gait in Parkinson's disease: a pilot randomized controlled study. Clin Rehabil. 2014;28(11):1115–24.CrossRef
31.
Verheyden G, Purdey J, Burnett M, Cole J, Ashburn A. Immediate effect of transcranial direct current stimulation on postural stability and functional mobility in Parkinson's disease. Movement Disorders. 2013;28(14):2040–1.CrossRef
32.
Fernandez-Lago H, Bello O, Mora-Cerda F, Montero-Camara J, Fernandez-Del-Olmo MA. Treadmill walking combined with anodal transcranial direct current stimulation in Parkinson disease: a pilot study of kinematic and neurophysiological effects. Am J Physical Medicine Rehabil. 2017;96(11):801–8.CrossRef
33.
Kaski D, Allum JH, Bronstein AM, Dominguez RO. Applying anodal tDCS during tango dancing in a patient with Parkinson's disease. Neurosci Lett. 2014;568:39–43.CrossRef
34.
Yotnuengnit P, Bhidayasiri R, Donkhan R, Chaluaysrimuang J, Piravej K. Effects of transcranial direct current stimulation plus physical therapy on gait in patients with Parkinson disease: a randomized controlled trial. Am J Physical Medicine Rehabil. 2018;97(1):7–15.CrossRef
35.
Kaski D, Bronstein AM. Treatments for neurological gait and balance disturbance: the use of noninvasive electrical brain stimulation. Advances Neurosci. 2014;2014:1–13.CrossRef
36.
Chen R. Transcranial direct current stimulation as a treatment for Parkinson's disease—interesting, but not ready for prime time. J Neurol Neurosurg Psychiatry. 2010;81(10):1061.CrossRef
37.
McNeely ME, Duncan RP, Earhart GM. Differential effects of tango, treadmill, and stretching interventions on gait in people with Parkinson’s disease, 20th International Congress of Parkinson's Disease and Movement Disorders. Berlin: International Parkinson and Movement Disorder Society; 2016.
38.
Kaski D, Quadir S, Patel M, Yousif N, Bronstein AM. Enhanced locomotor adaptation aftereffect in the "broken escalator" phenomenon using anodal tDCS. J Neurophysiol. 2012;107(9):2493–505.CrossRef
39.
Poortvliet P, Hsieh B, Cresswell A, Au J, Meinzer M. Cerebellar transcranial direct current stimulation improves adaptive postural control. Clin Neurophysiol. 2018;129(1):33–41.CrossRef
40.
Mioshi E, Dawson K, Mitchell J, Arnold R, Hodges JR. The Addenbrooke's Cognitive Examination Revised (ACE-R): a brief cognitive test battery for dementia screening. Int J Geriatr Psychiatry. 2006;21(11):1078–85.CrossRef
41.
Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, et al. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008;23(15):2129–70.CrossRef
42.
Mantyjarvi M, Laitinen T. Normal values for the Pelli-Robson contrast sensitivity test. J Cataract Refract Surg. 2001;27(2):261–6.CrossRef
43.
Haymes SA, Chen J. Reliability and validity of the Melbourne Edge Test and High/Low Contrast Visual Acuity chart. Optom Vis Sci. 2004;81(5):308–16.CrossRef
44.
Bailey IL, Lovie JE. New design principles for visual acuity letter charts. Am J Optom Physiol Optic. 1976;53(11):740–5.CrossRef
45.
Bailey IL, Lovie-Kitchin JE. Visual acuity testing. From the laboratory to the clinic. Vis Res. 2013;90:2–9.CrossRef
46.
Nolano M, Provitera V, Estraneo A, Selim MM, Caporaso G, Stancanelli A, et al. Sensory deficit in Parkinson's disease: evidence of a cutaneous denervation. Brain. 2008;131(Pt 7):1903–11.CrossRef
47.
Kegelmeyer DA, Kloos AD, Thomas KM, Kostyk SK. Reliability and validity of the Tinetti Mobility Test for individuals with Parkinson disease. Phys Ther. 2007;87(10):1369–78.CrossRef
48.
Wang C, Chen P, Zhuang J. Validity and reliability of International Physical Activity Questionnaire-Short Form in Chinese youth. Res Q Exerc Sport. 2013;84(Suppl 2):S80–6.CrossRef
49.
Franchignoni F, Giordano A, Ronconi G, Rabini A, Ferriero G. Rasch validation of the Activities-specific Balance Confidence Scale and its short versions in patients with Parkinson's disease. J Rehabil Med. 2014;46(6):532–9.CrossRef
50.
Jenkinson C, Fitzpatrick R, Peto V, Greenhall R, Hyman N. The Parkinson's Disease Questionnaire (PDQ-39): development and validation of a Parkinson's disease summary index score. Age Ageing. 1997;26(5):353–7.CrossRef
51.
Giladi N, Shabtai H, Simon ES, Biran S, Tal J, Korczyn AD. Construction of freezing of gait questionnaire for patients with Parkinsonism. Parkinsonism Relat Disord. 2000;6(3):165–70.CrossRef
52.
Goetz CG, Poewe W, Rascol O, Sampaio C, Stebbins GT, Counsell C, et al. Movement Disorder Society Task Force report on the Hoehn and Yahr staging scale: status and recommendations. Mov Disord. 2004;19(9):1020–8.CrossRef
53.
Levine D, Richards J, Whittle MW. Whittle's gait analysis. 5th ed. London, Edinburgh: Churchill Livingstone/Elsevier; 2012.
54.
Perry JB, Judith M. Gait analysis: normal and pathological function. 2nd ed. Thorofare: SLACK; 2010.
55.
da Silva BA, Faria C, Santos MP, Swarowsky A. Assessing Timed Up and Go in Parkinson's disease: reliability and validity of Timed Up and Go Assessment of biomechanical strategies. J Rehabil Med. 2017;49(9):723–31.CrossRef
56.
Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000;10(5):361–74.CrossRef
57.
Fregni F, Boggio PS, Santos MC, Lima M, Vieira AL, Rigonatti SP, et al. Noninvasive cortical stimulation with transcranial direct current stimulation in Parkinson's disease. Mov Disord. 2006;21(10):1693–702.CrossRef
58.
Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011;14(8):1133–45.CrossRef
59.
Lee C, Jung YJ, Lee SJ, Im CH. COMETS2: An advanced MATLAB toolbox for the numerical analysis of electric fields generated by transcranial direct current stimulation. J Neurosci Methods. 2017;277:56–62.CrossRef
60.
Hass CJ, Bishop M, Moscovich M, Stegemoller EL, Skinner J, Malaty IA, et al. Defining the clinically meaningful difference in gait speed in persons with Parkinson disease. J Neurol Phys Ther. 2014;38(4):233–8.CrossRef
61.
Little RJ, D'Agostino R, Cohen ML, Dickersin K, Emerson SS, Farrar JT, et al. The prevention and treatment of missing data in clinical trials. N Engl J Med. 2012;367(14):1355–60.CrossRef
62.
Winter DA. The biomechanics and motor control of human gait: normal, elderly and pathological. 2nd ed. Waterloo: University of Waterloo Press; 1991.
63.
Wasserstein RL, Lazar NA. The ASA's statement on p-values: context, process, and purpose. Am Stat. 2016;70(2):129–33.CrossRef
64.
Olanow CW, Watts RL, Koller WC. An algorithm (decision tree) for the management of Parkinson's disease (2001): treatment guidelines. Neurology. 2001;56(11 Suppl 5):S1–S88.CrossRef
65.
Jankovic J. Complications and limitations of drug therapy for Parkinson's disease. Neurology. 2000;55(12 Suppl 6):S2–6.PubMed
Metadata
Title
Effects of transcranial direct current stimulation on gait in people with Parkinson’s disease: study protocol for a randomized, controlled clinical trial
Authors
Vida Alizad
Marcus Meinzer
Laurent Frossard
Remco Polman
Simon Smith
Graham Kerr
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2982-z

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