Female RNA Concussion (FeRNAC) study protocol: Assessing Hormone Profiles and Salivary RNA in Females with Concussion by Emergency Departments in New Zealand; a prospective cohort study.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12623001129673

Acronym

FeRNAC study

Enrollment

Registered

2023-11-02

Start date

2023-01-26

Completion date

2024-02-29

Last updated

2023-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to better understand how sex hormones impact on symptom severity and duration and salivary biomarker release in females following concussion and whether levels of hormones are related to symptoms after the injury. Female sex hormones are linked to brain health and function; more female specific research is needed to understand how sex hormones influence brain injury. There are differences in the way that males and females experience concussion. Diagnosis and management of concussion is symptom based. Even for highly trained doctors, it can sometimes be difficult to diagnose a concussion, and to understand why someone is having symptoms after injury. It can also be hard to track improvements and changes in symptoms during recovery from concussion to decide if someone is ready to return to school/work or sport. Going back to school/work or sport before you are fully recovered may make symptoms worse and last longer and may also increase the risk of sustaining a second injury. Following concussion biomarkers are released into saliva. These molecules, small segments of cell Ribonucleic Acid (sncRNAs), offer a potential objective way to confirm diagnosis of concussion. These biomarkers have only been studied in males, it is not yet understood if the expression of sncRNA’s is influenced by the female sex hormones.

Interventions

Females presenting to ED with a concussion. These patients will provide a saliva sample upon admission to ED when the concussion diagnosis is confirmed to investigate the presence of specific biomarkers and will exit the study when they are asymptomatic and have recovered from the concussion. The number of days it takes to recover will be recorded for a maximum of 3 months.

Eligibility

Sex/Gender

All

Age

16 Years to 50 Years

Healthy volunteers

Inclusion criteria

Females of reproductive age – 16-50 years (with a menstrual cycle for a minimum of 2 years). Natural regular menstrual cycle ~28-35 days long, or Currently taking Oral Contraceptive Pill (OCP), or Currently have Intra Uterine Device (IUD), or Polycystic Ovarian Syndrome (PCOS), or Oligomenorrheic (irregular periods), or Amenorrheic (loss of periods for 3 months or longer) Confirmed diagnosis of concussion by a medical doctor (within last 10 days)

Exclusion criteria

Had more than three or more previously diagnosed concussions. Current concussion was more than 10 days ago. Post-menopause. Started taking medication that would alter reproductive hormone concentrations (Corticosteroids, e.g., Prednisone. Antidepressant or Antipsychotic medication) within the last 3 months. Current clinical diagnosis of an eating disorder. Pre-diagnosed psychiatric disorder. Pre-diagnosed neurological condition. GCS score less than 15 at 4 hours after initial assessment. These patients may be referred for a CT scan and will not be eligible for the study.

Outcome results