Evaluation of a home-based transcranial direct current stimulation (tDCS) treatment device for chronic pain: Study protocol for a randomised controlled trial

Trials

Volumn 16, Issue 1, 2015, Pages

  O'Neill, Francis ^a,b   Sacco, Paul ^a   Nurmikko, Turo ^a  

^a Clinical Sciences Centre   (United Kingdom)

^b LIVERPOOL UNIVERSITY DENTAL HOSPITAL   (United Kingdom)

Author keywords

Brain stimulation; Motor cortex (M1); Pain; Repetitive transcranial magnetic stimulation (rTMS); Transcranial direct current stimulation (tDCS)

Indexed keywords

ADULT; AGED; ANALGESIC ACTIVITY; ARTICLE; BRAIN DEPTH STIMULATION; CHRONIC PAIN; CLINICAL ARTICLE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DEVICE SAFETY; DOUBLE BLIND PROCEDURE; HOSPITAL ANXIETY AND DEPRESSION SCALE; HUMAN; INTENTION TO TREAT ANALYSIS; MOTOR CORTEX; NERVE STIMULATOR; NEUROPATHIC PAIN; PAIN ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; SELF REPORT; SHORT FORM 36; TRANSCRANIAL DIRECT CURRENT STIMULATION; TRANSCRANIAL MAGNETIC STIMULATION SYSTEM; TREATMENT OUTCOME; CLINICAL PROTOCOL; DEVICES; SAMPLE SIZE;

CHRONIC PAIN; CLINICAL PROTOCOLS; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; HUMANS; SAMPLE SIZE; TRANSCRANIAL DIRECT CURRENT STIMULATION;

EID: 84928532583     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-015-0710-5     Document Type: Article

References (43)

1. Tsubokawa T, Katayama Y, Yamamoto T, Hirayama T, Koyama S. Chronic motor cortex stimulation in patients with thalamic pain. J Neurosurg. 1993;78:393-401.
2. O'Connell NE, Wand BM, Marston L, Spencer S, Desouza LH. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2014;4:CD008208-8.
3. Nurmikko TJ, MacIver K, Bresnahan R, Sacco P. Repetitive transcranial magnetic stimulation (rTMS) of motor cortex in neuropathic pain - the impact of choice of target site. 15th World Congress on Pain, Buenos Aires, October 6-12, 2014.
4. Lefaucheur J-PJ, Drouot XX, Ménard-Lefaucheur II, Keravel YY, Nguyen J-PJ. Motor cortex rTMS in chronic neuropathic pain: pain relief is associated with thermal sensory perception improvement. J Neurol Neurosurg Psychiatr. 2008;79:1044-9.
5. Lefaucheur JP, Drouot X, Menard-Lefaucheur I, Zerah F, Bendib B, Cesaro P, et al. Neurogenic pain relief by repetitive transcranial magnetic cortical stimulation depends on the origin and the site of pain. J Neurol Neurosurg Psychiatr. 2004;75:612-6.
6. Bindman LJ, Lippold OC, Redfearn JW. The action of brief polarizing currents on the cerebral cortex of the rat (1) during current flow and (2) in the production of long-lasting after-effects. J Physiol. 1964;172:369-82.
7. Creutzfeldt OD, Fromm GH, Kapp H. Influence of transcortical d-c currents on cortical neuronal activity. Exp Neurol. 1962;5:436-52.
8. Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, et al. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008;1:206-23.
9. Fregni F, Boggio PS, Mansur CG, Wagner T, Ferreira MJL, Lima MC, et al. Transcranial direct current stimulation of the unaffected hemisphere in stroke patients. Neuroreport. 2005;16:1551-5.
10. Fregni F, Thome-Souza S, Nitsche MA, Freedman SD, Valente KD, Pascual-Leone A. A controlled clinical trial of cathodal DC polarization in patients with refractory epilepsy. Epilepsia. 2006;47:335-42.
11. Fregni F, Boggio PS, Nitsche MA, Marcolin MA, Rigonatti SP, Pascual-Leone A. Treatment of major depression with transcranial direct current stimulation. Bipolar Disord. 2006;8:203-4.
12. 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;21:1693-702.
13. Antal A, Brepohl N, Poreisz C, Boros K, Csifcsak G, Paulus W. Transcranial direct current stimulation over somatosensory cortex decreases experimentally induced acute pain perception. Clin J Pain. 2008;24:56-63.
14. Csifcsak G, Antal A, Hillers F, Levold M, Bachmann CG, Happe S, et al. Modulatory effects of transcranial direct current stimulation on laser-evoked potentials. Pain Med. 2009;10:122-32.
15. Boggio PS, Zaghi S, Lopes M, Fregni F. Modulatory effects of anodal transcranial direct current stimulation on perception and pain thresholds in healthy volunteers. Eur J Neurol. 2008;15:1124-30.
16. Borckardt JJ, Bikson M, Frohman H, Reeves ST, Datta A, Bansal V, et al. A pilot study of the tolerability and effects of high-definition transcranial direct current stimulation (HD-tDCS) on pain perception. J Pain. 2012;13:112-20.
17. Borckardt JJ, Romagnuolo J, Reeves ST, Madan A, Frohman H, Beam W, et al. Feasibility, safety, and effectiveness of transcranial direct current stimulation for decreasing post-ERCP pain: a randomized, sham-controlled, pilot study. Gastrointest Endosc. 2011;73:1158-64.
18. Fregni FF, Gimenes RR, Valle ACA, Ferreira MJLM, Rocha RRR, Natalle LL, et al. A randomized, sham-controlled, proof of principle study of transcranial direct current stimulation for the treatment of pain in fibromyalgia. Arthritis & Rheumatism. 2006;54:3988-98.
19. Valle A, Roizenblatt S, Botte S, Zaghi S, Riberto M, Tufik S, et al. Efficacy of anodal transcranial direct current stimulation (tDCS) for the treatment of fibromyalgia: results of a randomized, sham-controlled longitudinal clinical trial. J Pain Manag. 2009;2:353-61.
20. Fenton BW, Palmieri PA, Boggio P, Fanning J, Fregni F. A preliminary study of transcranial direct current stimulation for the treatment of refractory chronic pelvic pain. Brain Stimul. 2009;2:103-7.
21. Silva G, Miksad R, Freedman SD, Pascual-Leone A, Jain S, Gomes DL, et al. Treatment of cancer pain with noninvasive brain stimulation. J Pain Symptom Manage. 2007;34:342-5.
22. Fregni F, Boggio PS, Lima MC, Ferreira MJL, Wagner T, Rigonatti SP, et al. A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury. Pain. 2006;122:197-209.
23. Soler MD, Kumru H, Pelayo R, Vidal J, Tormos JM, Fregni F, et al. Effectiveness of transcranial direct current stimulation and visual illusion on neuropathic pain in spinal cord injury. Brain. 2010;133:2565-77.
24. Wrigley PJ, Gustin SM, McIndoe LN, Chakiath RJ, Henderson LA, Siddall PJ. Longstanding neuropathic pain after spinal cord injury is refractory to transcranial direct current stimulation: a randomized controlled trial. Pain. 2013;154:2178-84.
25. Antal A, Terney D, Kühnl S, Paulus W. Anodal transcranial direct current stimulation of the motor cortex ameliorates chronic pain and reduces short intracortical inhibition. J Pain Symptom Manage. 2010;39:890-903.
26. Lefaucheur J-P. Use of repetitive transcranial magnetic stimulation in pain relief. Expert Rev Neurother. 2008;8:799-808.
27. Liebetanz D, Nitsche MA, Tergau F, Paulus W. Pharmacological approach to the mechanisms of transcranial DC-stimulation-induced after-effects of human motor cortex excitability. Brain. 2002;125:2238-47.
28. Nitsche MA, Fricke K, Henschke U, Schlitterlau A, Liebetanz D, Lang N, et al. Pharmacological modulation of cortical excitability shifts induced by transcranial direct current stimulation in humans. J Physiol. 2003;553:293-301.
29. Antal A, Paulus W. A case of refractory orofacial pain treated by transcranial direct current stimulation applied over hand motor area in combination with NMDA agonist drug intake. Brain Stimul. 2011;4:117-21.
30. Lang N, Siebner HR, Ward NS, Lee L, Nitsche MA, Paulus W, et al. How does transcranial DC stimulation of the primary motor cortex alter regional neuronal activity in the human brain? Eur J Neurosci. 2005;22:495-504.
31. Garcia-Larrea L, Peyron R, Mertens P, Grégoire MC, Lavenne F, Bonnefoi F, et al. Positron emission tomography during motor cortex stimulation for pain control. Stereotact Funct Neurosurg. 1997;68:141-8.
32. Garcia-Larrea L, Peyron R, Mertens P, Grégoire MC, Lavenne F, Le Bars D, et al. Electrical stimulation of motor cortex for pain control: a combined PET-scan and electrophysiological study. Pain. 1999;83:259-73.
33. Peyron R, Faillenot I, Mertens P, Laurent B, Garcia-Larrea L. Motor cortex stimulation in neuropathic pain. Correlations between analgesic effect and hemodynamic changes in the brain. A PET study. Neuroimage. 2007;34:310-21.
34. Lin R. Imaging the Neuromodulation of Pain. Oxford, UK: University of Oxford; 2011.
35. Arul-Anandam AP, Loo C, Sachdev P. Transcranial direct current stimulation - what is the evidence for its efficacy and safety? F1000 Med Rep. 2009;1:58 (doi:10.3410/M1-58).
36. Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007;72:208-14.
37. Nitsche MA, Liebetanz D, Lang N, Antal A, Tergau F, Paulus W. Safety criteria for transcranial direct current stimulation (tDCS) in humans. Clin Neurophysiol. 2003;114:2220-2. author reply 2222-3.
38. Treede R-D, Jensen TS, Campbell JN, Cruccu G, Dostrovsky JO, Griffin JW, et al. Neuropathic pain: redefinition and a grading system for clinical and research purposes. Neurology. 2008;70:1630-5.
39. Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005;113:9-19.
40. Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002;52:69-77.
41. Horton AMJ, Alana S. Validation of the mini-mental state examination. Int J Neurosci. 1990;53:209-12.
42. Gandiga PC, Hummel FC, Cohen LG. Transcranial DC stimulation (tDCS): a tool for double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol. 2006;117:845-50.
43. Kenward MG, Roger JH. The use of baseline covariates in crossover studies. Biostatistics. 2010;11:1-17.