Background
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. Randomized 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
- This study protocol reports a multicenter, 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
- Ethical approval for this trial was granted by the Institutional Review Board of Huashan Hospital, Fudan University, and by the institutional review boards of all participating institutions.
- All patients will sign information prior to enrolment.
- Patients may withdraw from the study at any time.
- Important protocol modifications will be communicated to the relevant members of the research team.
- All procedures will be performed in accordance with the principles of the Declaration of Helsinki.
- The study findings will be disseminated through peer-reviewed publications and conference presentations
Patient and public involvement
- Patients and the public were not involved in the design and conception of this study.
- The study results will be disseminated to the public upon completion of the trial and individual test results will be provided to patients upon request.
Discussion
- Owing to the high morbidity and heavy disease burden of stroke in China,37 there is an urgent need for effective treatments of chronic poststroke aphasia.
- This current manuscript describes the methodology of a trial designed to evaluate the effects of NC7 on language-impairment symptoms in patients with chronic poststroke aphasia.
- This study bears major importance because it could provide evidence for the validity of a novel therapeutic strategy for improving language function while attenuating stroke-related dysfunctions.
- This study focuses on the evaluation of postoperative language function.
- Language function can be assessed using naming tests and communication ability assessments, for instance.
- Patients with aphasia who receive iSLT or non-invasive peripheral stimulation can exhibit improvements in naming ability and social communication; however, the effect sizes are usually modest.
- In a previous study, it was found that the naming ability of patients after CC7 significantly improved, and many other researchers have also used the suitable correct spontaneous naming scores as the only BNT-related index for evaluating language function.
- In this study, the BNT scale will be used as an evaluation index for language function as the primary outcome and the WAB, CADL Communication Scale, ADL Scale and Post-Stroke Depression Scale scores as secondary indicators of language repetition, listening comprehension, communication ability, daily life and psychological status.
- The ICF speech and language function assessment can detect the degree of changes in voice intonation, oral motor ability, articulation intelligibility and oral expression to exclude the possible reduction of spasticity after neurotomy for interfering with study results.
Conclusion
In conclusion, this will be the first RCT to evaluate the effect of surgery in patients with chronic poststroke aphasia for whom no effective treatment is available. If found to be efficient, this strategy can be implemented regularly because of its ease of application and low cost. Moreover, larger trials should be extended to other diseases with central nerve injuries to assess the positive effects of this strategy on language and other functions. Once the hypothesis is confirmed, this trial will provide important evidence to support the use of NC7 at the intervertebral foramen as a novel treatment approach for chronic aphasia. A limitation of this study is that it is not double-blind but evaluator-blind, and the experimental group may experience a minor placebo effect. Nevertheless, a secondary endpoint assessment at 6 months post intervention is scheduled to be conducted to offset the short-term postsurgery placebo effect. At that time, the patient’s placebo effect due to invasive interventions will be greatly reduced.