Effect and safety of C7 neurotomy at the intervertebral foramen in patients with chronic poststroke aphasia: a multicentre, randomised, controlled study protocol
Introduction Aphasia 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 efficac...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-05-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/5/e065173.full |
| _version_ | 1827180728997117952 |
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| author | Ying Zhang Minzhi Lv Ling Ding Tie Li Juntao Feng Ruiping Hu Wenshuo Chang Xingyi Ma Wenjun Qi Xiuen Chen Yudong Gu Wendong Xu |
| author_facet | Ying Zhang Minzhi Lv Ling Ding Tie Li Juntao Feng Ruiping Hu Wenshuo Chang Xingyi Ma Wenjun Qi Xiuen Chen Yudong Gu Wendong Xu |
| author_sort | Ying Zhang |
| collection | DOAJ |
| description | Introduction Aphasia 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 analysis This 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 dissemination This 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 number ChiCTR2200057180. |
| first_indexed | 2024-04-09T14:43:24Z |
| format | Article |
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| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2025-03-21T05:35:32Z |
| publishDate | 2023-05-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-5c86336424a6452ea8820538d45e5f9a2024-07-24T18:00:09ZengBMJ Publishing GroupBMJ Open2044-60552023-05-0113510.1136/bmjopen-2022-065173Effect and safety of C7 neurotomy at the intervertebral foramen in patients with chronic poststroke aphasia: a multicentre, randomised, controlled study protocolYing Zhang0Minzhi Lv1Ling Ding2Tie Li3Juntao Feng4Ruiping Hu5Wenshuo Chang6Xingyi Ma7Wenjun Qi8Xiuen Chen9Yudong Gu10Wendong Xu11Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, People`s Republic of ChinaCenter of Evidence-Based Medicine, Department of Biostatistics, School of Public Health, Fudan University, Shanghai, People`s Republic of ChinaDepartment of Rehabilitation, Shanghai Pudong Hospital, Shanghai, People`s Republic of ChinaDepartment of Hand Surgery, Huashan Hospital, Fudan University, Shanghai, People`s Republic of ChinaDepartment of Hand Surgery, Huashan Hospital, Fudan University, Shanghai, People`s Republic of ChinaDepartment of Rehabilitation, Huashan Hospital, Fudan University, Shanghai, People`s Republic of ChinaInstitute of Linguistics, Shanghai International Studies University, Shanghai, People`s Republic of ChinaDepartment of Hand Surgery, Huashan Hospital, Fudan University, Shanghai, People`s Republic of ChinaDepartment of Hand Surgery, Huashan Hospital, Fudan University, Shanghai, People`s Republic of ChinaDepartment of Rehabilitation, Huadong Hospital Affiliated to Fudan University, Shanghai, People`s Republic of ChinaDepartment of Hand Surgery, Huashan Hospital, Fudan University, Shanghai, People`s Republic of ChinaDepartment of Hand Surgery, Huashan Hospital, Fudan University, Shanghai, People`s Republic of ChinaIntroduction Aphasia 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 analysis This 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 dissemination This 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 number ChiCTR2200057180.https://bmjopen.bmj.com/content/13/5/e065173.full |
| spellingShingle | Ying Zhang Minzhi Lv Ling Ding Tie Li Juntao Feng Ruiping Hu Wenshuo Chang Xingyi Ma Wenjun Qi Xiuen Chen Yudong Gu Wendong Xu Effect and safety of C7 neurotomy at the intervertebral foramen in patients with chronic poststroke aphasia: a multicentre, randomised, controlled study protocol BMJ Open |
| title | Effect and safety of C7 neurotomy at the intervertebral foramen in patients with chronic poststroke aphasia: a multicentre, randomised, controlled study protocol |
| title_full | Effect and safety of C7 neurotomy at the intervertebral foramen in patients with chronic poststroke aphasia: a multicentre, randomised, controlled study protocol |
| title_fullStr | Effect and safety of C7 neurotomy at the intervertebral foramen in patients with chronic poststroke aphasia: a multicentre, randomised, controlled study protocol |
| title_full_unstemmed | Effect and safety of C7 neurotomy at the intervertebral foramen in patients with chronic poststroke aphasia: a multicentre, randomised, controlled study protocol |
| title_short | Effect and safety of C7 neurotomy at the intervertebral foramen in patients with chronic poststroke aphasia: a multicentre, randomised, controlled study protocol |
| title_sort | effect and safety of c7 neurotomy at the intervertebral foramen in patients with chronic poststroke aphasia a multicentre randomised controlled study protocol |
| url | https://bmjopen.bmj.com/content/13/5/e065173.full |
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