Improvement of language function after C7 neurotomy at the intervertebral foramen in patients with chronic post-stroke aphasia: a phase I cohort study

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. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ChiCTR2200060147 ### Funding Statement This study was funded by the National key R&D program of China (2022YFC3602700), National Natural Science Foundation of China (82021002, 81830063 and 82072539), Shanghai Municipal Science and Technology Major Project (2018SHZDZX05), CAMS Innovation Fund for Medical Sciences (2019-I2M-5-007, Shanghai Municipal Clinical Medical Center Project(2022ZZ01007), Youth Talent Project of Shanghai Municipal Health Commission (2022YQ009). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Institutional review board of Shanghai Jing'an District Central Hospital (Affiliated to Hua Shan hospital of Fudan University) gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors.