Background: Post-stroke aphasia is a common but intractable sequela which still needs new and more effective treatments. Evidence from follow-ups after contralateral seventh cervical nerve transfer surgery indicated that nerve transection leads to immediate language improvements in patients with right post stroke aphasia. Objective: Through a prospective cohort design, this study aims to prove that C7 neurotomy at the intervertebral foramen (NC7) combined with a 3-week intensive speech and language therapy (iSLT) can improve the language function in post-stroke aphasia patients. Methods: In this study, patients aged over 18 years old and had been diagnosed with post-stroke aphasia for 1 year or longer were included. Primary outcomes were the change in the ability to retrieve personally relevant words in Boston Naming Test (BNT) with follow-up assessment after three weeks' iSLT post operatively. As well as several secondary outcome measures including the Western Aphasia Battery (WAB), daily communication abilities (measured by the Communication Activities of Daily Living Third Edition [CADL 3]) and Fugl-Meyer of upper limb part (UEFM). Results: The average increase of BNT score was 11.2 points from baseline to 3 weeks post operatively (P=0.001, 95%CI: 8.1-14.1). The WAB and CADL-3 assessment showed 9.4, 10.4 points increasing in average (P<0.005, 95%CI: 4.6 to 14.1; P<0.001, 95%CI:6.7 to 14.1) from baseline to 4-week follow-up, respectively. The mean difference from baseline to 3 weeks post-operatively in UEFM score decreased 0.8 points (95% CI: -3.2 to 1.6; p<0.405). Conclusions: NC7 plus iSLT significantly improved the language function in patients with post-stroke aphasia, and did not significantly affect the motor function of the right limb. The mechanism of this surgery needs to be further explored.
IntroductionAphasia affects many stroke survivors; therefore, effective treatments are urgently needed. Preliminary clinical findings have suggested an association between contralateral C7–C7 cross nerve transfer and recovery from chronic aphasia. Randomised controlled trials supporting the efficacy of C7 neurotomy (NC7) are lacking. This study will explore the efficacy of NC7 at the intervertebral foramen for improving chronic poststroke aphasia.Methods and analysisThis study protocol reports a multicentre, randomised, assessor-blinded active-controlled trial. A total of 50 patients with chronic poststroke aphasia for over 1 year and with a aphasia quotient calculated by Western Aphasia Battery Aphasia Quotient (WAB-AQ) score below 93.8 will be recruited. Participants will be randomly assigned to 1 of 2 groups (25 individuals each) to receive NC7 plus intensive speech and language therapy (iSLT), or iSLT alone programme. The primary outcome is the change in Boston Naming Test score from baseline to the first follow-up after NC7 plus 3 weeks of iSLT or iSLT alone. The secondary outcomes include the changes in the WAB-AQ, Communication Activities of Daily Living-3, International Classification of Functioning, Disability and Health (ICF) speech language function, Barthel Index, Stroke Aphasic Depression Questionnaire-hospital version and sensorimotor assessments. The study will also collect functional imaging outcomes of naming and semantic violation tasks through functional MRI and electroencephalogram to evaluate the intervention-induced neuroplasticity.Ethics and disseminationThis study was approved by the institutional review boards of Huashan Hospital, Fudan University, and all participating institutions. The study findings will be disseminated through peer-reviewed publications and conference presentations.Trial registration numberChiCTR2200057180.
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