The synergistic effect of acupuncture and computer-based cognitive training on post-stroke cognitive dysfunction: a study protocol for a randomized controlled trial of 2 × 2 factorial design

BMC Complementary and Alternative Medicine

Lidian Chen¹  Guohua Zheng²  Zhicheng Lin³  Cai Jiang⁴  Jing Tao⁴  Jia Huang⁴  Haicheng Ye⁴  Shanli Yang³ 

[1] Fujian University of Traditional Chinese Medicine, Fuzhou 350122, China;Academy of Integrative Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou 350122, China;Rehabilitation Hospital Affiliated to Fujian University of TCM, Fuzhou 350003, China;Rehabilitation Medicine College, Fujian University of Traditional Chinese Medicine, Fuzhou 350122, China

关键词: Cognitive dysfunction;    Stroke;    Computer-based cognitive training;    Acupuncture;   

Others  :  1087025
DOI  :  10.1186/1472-6882-14-290

 received in 2014-05-17, accepted in 2014-07-30,  发布年份 2014

【 摘 要 】

Background

Stroke is one of the most common causes of cognitive impairment. Up to 75% of stroke survivors may be considered to have cognitive impairment, which severely limit individual autonomy for successful reintegration into family, work and social life. The clinical efficacy of acupuncture with Baihui (DU20) and Shenting (DU24) in stroke and post-stroke cognitive impairment has been previously demonstrated. Computer-assisted cognitive training is part of conventional cognitive rehabilitation and has also shown to be effective in improvement of cognitive function of affected patients. However, the cognitive impairment after stroke is so complexity that one single treatment cannot resolve effectively. Besides, the effects of acupuncture and RehaCom cognitive training have not been systematically compared, nor has the possibility of a synergistic effect of combination of the two therapeutic modalities been evaluated. Our primary aim of this trial is to evaluate the synergistic effect of acupuncture and RehaCom cognitive training on cognitive dysfunction after stroke.

Method/Design

A randomized controlled trial of 2 × 2 factorial design will be conducted in the Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine. A total of 240 patients with cognitive dysfunction after stroke who meet the eligibility criteria will be recruited and randomized into RehaCom training group, acupuncture group, a combination of both or control group in a 1:1:1:1 ratio. All patients will receive conventional treatment. The interventions will last for 12 weeks (30 min per day, Monday to Friday every week). Evaluations will be conducted by blinded assessors at baseline and again at 4, 8 and 12 weeks. Outcome measurements include mini–mental state examination (MMSE), Montreal cognitive assessments (MoCA), functional independence measure scale (FIM) and adverse events.

Discussion

The results of this trial are expected to clarify the synergistic effect of acupuncture and RehaCom cognitive training on cognitive dysfunction after stroke. Furthermore, to confirm whether combined or alone of acupuncture and RehaCom cognitive training, is more effective than conventional treatment in the management of post-stroke cognitive dysfunction.

Trial registration

Chinese Clinical Trial Registry: ChiCTR-TRC-13003704.

Registration date: 4 September, 2013.

【 授权许可】

   
2014 Yang et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Minino AM, Murphy SL, Xu J, Kochanek KD: Deaths: final data for 2008. Natl Vital Stat Rep 2011, 59(10):1-126.
• [2]Tarraga L, Boada M, Modinos G, Espinosa A, Diego S, Morera A, Guitart M, Balcells J, Lopez OL, Becker JT: A randomised pilot study to assess the efficacy of an interactive, multimedia tool of cognitive stimulation in Alzheimer’s disease. J Neurol Neurosurg Psychiatry 2006, 77(10):1116-1121.
• [3]Franceschi C: So as to avoid any misunderstanding about Cure Conservatrice et Hemodynamique de l’Insuffisance Veineuse en Ambulatoire (CHIVA). Phlebology 2010, 25(4):212-213.
• [4]Haring HP: Cognitive impairment after stroke. Curr Opin Neurol 2002, 15(1):79-84.
• [5]Mok VC, Wong A, Lam WW, Fan YH, Tang WK, Kwok T, Hui AC, Wong KS: Cognitive impairment and functional outcome after stroke associated with small vessel disease. J Neurol Neurosurg Psychiatry 2004, 75(4):560-566.
• [6]Mok V, Chang C, Wong A, Lam WW, Richards PS, Wong KT, Wong KS: Neuroimaging determinants of cognitive performances in stroke associated with small vessel disease. J Neuroimaging 2005, 15(2):129-137.
• [7]Alvarez-Sabin J, Roman GC: Citicoline in vascular cognitive impairment and vascular dementia after stroke. Stroke 2011, 42(1 Suppl):S40-S43.
• [8]Tatemichi TK, Desmond DW, Stern Y, Paik M, Sano M, Bagiella E: Cognitive impairment after stroke: frequency, patterns, and relationship to functional abilities. J Neurol Neurosurg Psychiatry 1994, 57(2):202-207.
• [9]Desmond DW, Moroney JT, Paik MC, Sano M, Mohr JP, Aboumatar S, Tseng CL, Chan S, Williams JB, Remien RH: Frequency and clinical determinants of dementia after ischemic stroke. Neurology 2000, 54(5):1124-1131.
• [10]Hachinski V, Munoz D: Vascular factors in cognitive impairment–where are we now? Ann N Y Acad Sci 2000, 903:1-5.
• [11]Pendlebury ST, Rothwell PM: Prevalence, incidence, and factors associated with pre-stroke and post-stroke dementia: a systematic review and meta-analysis. Lancet Neurol 2009, 8(11):1006-1018.
• [12]Stingele R, Berger J, Alfke K, Eckstein HH, Fraedrich G, Allenberg J, Hartmann M, Ringleb PA, Fiehler J, Bruckmann H, Hennerici M, Jansen O, Klein G, Kunze A, Marx P, Niederkorn K, Schmiedt W, Solymosi L, Zeumer H, Hacke W: Clinical and angiographic risk factors for stroke and death within 30 days after carotid endarterectomy and stent-protected angioplasty: a subanalysis of the SPACE study. Lancet Neurol 2008, 7(3):216-222.
• [13]Shim H: Vascular cognitive impairment and post-stroke cognitive deficits. Curr Neurol Neurosci Rep 2014, 14(1):418.
• [14]Farooq MU, Gorelick PB: Vascular cognitive impairment. Curr Atheroscler Rep 2013, 15(6):330.
• [15]Jansen G, Lundeberg T, Kjartansson J, Samuelson UE: Acupuncture and sensory neuropeptides increase cutaneous blood flow in rats. Neurosci Lett 1989, 97(3):305-309.
• [16]Johansson K, Lindgren I, Widner H, Wiklund I, Johansson BB: Can sensory stimulation improve the functional outcome in stroke patients? Neurology 1993, 43(11):2189-2192.
• [17]Hu HH, Chung C, Liu TJ, Chen RC, Chen CH, Chou P, Huang WS, Lin JC, Tsuei JJ: A randomized controlled trial on the treatment for acute partial ischemic stroke with acupuncture. Neuroepidemiology 1993, 12(2):106-113.
• [18]Magnusson M, Johansson K, Johansson BB: Sensory stimulation promotes normalization of postural control after stroke. Stroke 1994, 25(6):1176-1180.
• [19]Wu JN: A short history of acupuncture. J Altern Complement Med 1996, 2(1):19-21.
• [20]Li W, Cheng YH, Yu XG: Observation on therapeutic effect of acupuncture combined with medicine on mild cognition disorders in patients with post-stroke. Zhongguo Zhen Jiu 2012, 32(1):3-7.
• [21]Feng Y, Bai L, Ren Y, Chen S, Wang H, Zhang W, Tian J: FMRI connectivity analysis of acupuncture effects on the whole brain network in mild cognitive impairment patients. Magn Reson Imaging 2012, 30(5):672-682.
• [22]Chen LP, Wang FW, Zuo F, Jia JJ, Jiao WG: Clinical research on comprehensive treatment of senile vascular dementia. J Tradit Chin Med 2011, 31(3):178-181.
• [23]Zhao L, Zhang H, Zheng Z, Huang J: Electroacupuncture on the head points for improving gnosia in patients with vascular dementia. J Tradit Chin Med 2009, 29(1):29-34.
• [24]Wang T, Liu CZ, Yu JC, Jiang W, Han JX: Acupuncture protected cerebral multi-infarction rats from memory impairment by regulating the expression of apoptosis related genes Bcl-2 and Bax in hippocampus. Physiol Behav 2009, 96(1):155-161.
• [25]Li G, Zhang X, Cheng H, Shang X, Xie H, Zhang X, Yu J, Han J: Acupuncture improves cognitive deficits and increases neuron density of the hippocampus in middle-aged SAMP8 mice. Acupunct Med 2012, 30(4):339-345.
• [26]Feng X, Yang S, Liu J, Huang J, Peng J, Lin J, Tao J, Chen L: Electroacupuncture ameliorates cognitive impairment through inhibition of NF-kappaB-mediated neuronal cell apoptosis in cerebral ischemia-reperfusion injured rats. Mol Med Rep 2013, 7(5):1516-1522.
• [27]Liu CZ, Yu JC, Zhang XZ, Fu WW, Wang T, Han JX: Acupuncture prevents cognitive deficits and oxidative stress in cerebral multi-infarction rats. Neurosci Lett 2006, 393(1):45-50.
• [28]Stringer A: Cognitive rehabilitation practice patterns: a survey of American Hospital Association Rehabilitation Programs. Clin Neuropsychol 2003, 17(1):34-44.
• [29]Chen SH, Thomas JD, Glueckauf RL, Bracy OL: The effectiveness of computer-assisted cognitive rehabilitation for persons with traumatic brain injury. Brain Inj 1997, 11(3):197-209.
• [30]Owen AM, Hampshire A, Grahn JA, Stenton R, Dajani S, Burns AS, Howard RJ, Ballard CG: Putting brain training to the test. Nature 2010, 465(7299):775-778.
• [31]Dou ZL, Man DW, Ou HN, Zheng JL, Tam SF: Computerized errorless learning-based memory rehabilitation for Chinese patients with brain injury: a preliminary quasi-experimental clinical design study. Brain Inj 2006, 20(3):219-225.
• [32]Fernandez E, Bringas ML, Salazar S, Rodriguez D, Garcia ME, Torres M: Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. MEDICC Rev 2012, 14(4):32-35.
• [33]Lun J, Oishi S, Coan JA, Akimoto S, Miao FF: Cultural variations in motivational responses to felt misunderstanding. Pers Soc Psychol Bull 2010, 36(7):986-996.
• [34]Bor J, Brunelin J, D’Amato T, Costes N, Suaud-Chagny MF, Saoud M, Poulet E: How can cognitive remediation therapy modulate brain activations in schizophrenia? An fMRI study. Psychiatry Res 2011, 192(3):160-166.
• [35]Solari A, Motta A, Mendozzi L, Pucci E, Forni M, Mancardi G, Pozzilli C: Computer-aided retraining of memory and attention in people with multiple sclerosis: a randomized, double-blind controlled trial. J Neurol Sci 2004, 222(1–2):99-104.
• [36]Wilson BA: Neuropsychological rehabilitation. Annu Rev Clin Psychol 2008, 4:141-162.
• [37]Zhou L, Zhang YL, Cao HJ, Hu H: Treating vascular mild cognitive impairment by acupuncture: a systematic review of randomized controlled trials. Zhongguo Zhong Xi Yi Jie He Za Zhi 2013, 33(12):1626-1630.
• [38]Prokopenko SV, Mozheyko EY, Petrova MM, Koryagina TD, Kaskaeva DS, Chernykh TV, Shvetzova IN, Bezdenezhnih AF: Correction of post-stroke cognitive impairments using computer programs. J Neurol Sci 2013, 325(1–2):148-153.
• [39]Zhao L, Zhang FW, Zhang H, Zhao Y, Zhou B, Chen WY, Zhu MJ: Mild cognitive impairment disease treated with electroacupuncture: a multi-center randomized controlled trial. Zhongguo Zhen Jiu 2012, 32(9):779-784.
• [40]Yu J, Wu X, Yang X: Rehabilitation clinical observation of head acupuncture combined with computer aided training on brain injury patients with cognitive deficits. Chin J Rehab Med 2013, 28(1):36-39.
• [41]Group FNCC: Diagnostic Criteria for All Kinds of Cerebrovascular Disease. 1996, 29(06):379-380.
• [42]Wang Y: Rehabilitation evaluation and assessment. Beijing: People’s Health Publishing House; 2008:295-296.
• [43]Maher CG, Sherrington C, Herbert RD, Moseley AM, Elkins M: Reliability of the PEDro scale for rating quality of randomized controlled trials. Phys Ther 2003, 83(8):713-721.
• [44]Yao M: Chinese prevention and treatment guidelines of cerebrovascular disease. J Apopl Nerv Dis 2006, 23(1):4-8.
• [45]Chen L: Out of the Misunderstanding of the Rehabilitation of Stroke Patients. Beijing: People’s Health Publishing House; 2008.
• [46]G S: RehaCom Version 5. Basic Manual. Magdegurg (DE), Volume 47 2003, 52. Available from: http://www.hasomed.de/fileadmin/user_upload/Rehacom/Manuale/ENG/RehaComEN.pdf webcite
• [47]Zamarian L, Benke T, Buchler M, Wenter J, Delazer M: Information about medications may cause misunderstanding in older adults with cognitive impairment. J Neurol Sci 2010, 298(1–2):46-51.
• [48]Li S, Yu B, Zhou D, He C, Kang L, Wang X, Jiang S, Chen X: Acupuncture for Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev 2011, 4:D7839.
• [49]Folstein MF, Folstein SE, McHugh PR: “Mini-mental state”. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975, 12(3):189-198.
• [50]Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H: The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc 2005, 53(4):695-699.
• [51]Wang W, Xie H: MoCA-Test-Chinese_Beijing. 2006. Available from: http://www.mocatest.org/pdf_files/test/MoCA-Test-Chinese_Beijing.pdf webcite
• [52]Dodds TA, Martin DP, Stolov WC, Deyo RA: A validation of the functional independence measurement and its performance among rehabilitation inpatients. Arch Phys Med Rehabil 1993, 74(5):531-536.
• [53]Chumney D, Nollinger K, Shesko K, Skop K, Spencer M, Newton RA: Ability of Functional Independence Measure to accurately predict functional outcome of stroke-specific population: systematic review. J Rehabil Res Dev 2010, 47(1):17-29.
• [54]Tanaka N, Nakatsuka M, Ishii H, Nakayama R, Hosaka R, Meguro K: Clinical utility of the functional independence measure for assessment of patients with Alzheimer’s disease and vascular dementia. Psychogeriatrics 2013, 13(4):199-205.
• [55]Bamford J, Sandercock P, Dennis M, Burn J, Warlow C: Classification and natural history of clinically identifiable subtypes of cerebral infarction. Lancet 1991, 337(8756):1521-1526.
• [56]Cha YJ, Kim H: Effect of computer-based cognitive rehabilitation (CBCR) for people with stroke: a systematic review and meta-analysis. NeuroRehabilitation 2013, 32(2):359-368.
• [57]Cao H, Wang Y, Chang D, Zhou L, Liu J: Acupuncture for vascular mild cognitive impairment: a systematic review of randomised controlled trials. Acupunct Med 2013, 31(4):368-374.
• [58]Gao Q, Niti M, Feng L, Yap KB, Ng TP: Omega-3 polyunsaturated fatty acid supplements and cognitive decline: Singapore Longitudinal Aging Studies. J Nutr Health Aging 2011, 15(1):32-35.
• [59]Durga J, van Boxtel MP, Schouten EG, Kok FJ, Jolles J, Katan MB, Verhoef P: Effect of 3-year folic acid supplementation on cognitive function in older adults in the FACIT trial: a randomised, double blind, controlled trial. Lancet 2007, 369(9557):208-216.
• [60]Freitas S, Simoes MR, Maroco J, Alves L, Santana I: Construct Validity of the Montreal Cognitive Assessment (MoCA). J Int Neuropsychol Soc 2012, 18(2):242-250.