Previously submitted to: JMIR Research Protocols (no longer under consideration since Aug 28, 2023)
Date Submitted: Aug 20, 2023
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Female RNA Concussion (FeRNAC) study protocol: Assessing Hormone Profiles and Salivary RNA Prospec-tively for Females with Confirmed Concussion by Emergency Departments in New Zealand.
ABSTRACT
Background:
Females of reproductive age report a greater number of concussion symptoms that can be more severe and longer in duration. The underlying mechanism for this sex difference is not yet well understood. Short non-coding Ribonucleic Acids (sncRNAs) are potential candidate biomarkers specific to concussion and have been studied in the saliva of male athletes. Female sex hormones may influence expression of these biomarkers. More female specific research is re-quired to inform optimal concussion prevention, recognition, and treatment protocols.
Objective:
To evaluate the presence of salivary sncRNA’s in females presenting to emergency departments (ED) with concussion and to investigate how hormone profiles and salivary hormone levels influence sncRNAs, symptom severity, and re-covery outcomes.
Methods:
This prospective cohort study recruits participants from New Zealand ED who are biologically female, of reproductive age (16-50 years) and with a diagnosis of concussion/mTBI from ED consulting healthcare professionals. Participants are excluded by ED healthcare professionals as part of initial routine concussion assessment if they have a pre-diagnosed psychiatric condition, neurological condition (i.e., epilepsy, cerebral palsy) or more than three previously diagnosed concussions. Participants provide two saliva samples for measurement of sex hormones and sncRNA’s, and online survey responses relating to hormone profile and symptom recovery at 7-day time points after injury until they report a full return to work/study.
Results:
This study received funding in January 2019. Data collection commenced February 2022, however there was interrupt-ed due to COVID related sickness and ED changes in November 2022. Study recruitment recommenced in January 2023 and is in progress. As of 18 August 2023, 14 women have been recruited. Data collection is expected to be com-pleted by December 2023, and analyses and publication of results are expected by mid-2024.
Conclusions:
If saliva samples confirm presence of sncRNA’s in females with concussion, it will provide evidence of the potential of saliva sampling as an objective tool to aid in diagnosis of and confirmation of recovery from concussion. Findings will determine whether expression of sncRNA’s is influenced by steroid hormones in females and therefore whether sali-vary sncRNA’s is a feasible and reliable tool for routine clinical use in females with concussion.
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