Acute Injury Markers in mTBI
- Conditions
- <p>mild traumatic brain injury</p>
- Registration Number
- NL-OMON24795
- Lead Sponsor
- MCG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 700
Patients with mild traumatic brain injury (mTBI) must be aged 18 years or older. Mild TBI is defined by a Glasgow Coma Scale score of 13-15 and loss of consciousness = 30 minutes and/or post-traumatic amnesia < 24 hours (Kayd et al. 1993). Inclusion criteria for the orthopedic control group are: age 18 years or older, and sustaining a minor injury to an extremity (e.g. sprain or uncomplicated fracture of wrist or ankle. For the healthy control group: age 18 years or older.
neurological or psychiatric co-morbidity, admission for prior TBI, drug or alcohol abuse, and mental retardation, language barriers or illiteracy, prohibiting understanding and completion of questionnaires. For the MRI-study: implanted ferromagnetic devices or objects, pregnancy or claustrophobia.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Glasgow Outcome Scale Extended (GOSE) at 6 months post-injury (Jennett et al. 1981). This questionnaire is validated. • Post-traumatic complaints (measured using the head injury symptom checklist (HISC) at 6 months post-injury (de Koning et al. 2016)). This questionnaire is validated.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Emergency department: • Blood cytokine levels. • Blood biomarker levels (proteins of cell injury). • Salivary cortisol levels. • Heartrate variability. Two weeks post-injury: • HISC at 2 weeks post-injury. • Anxiety/depression at 2 weeks post-injury (Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith 1983)). This questionnaire is validated. • Coping (Utrechtse Coping List (UCL) at 2 weeks post-injury(Schreurs et al. 1988)). This questionnaire is validated. • Personality characteristics (Big Five Inventory (BFI) at 2 weeks post-injury (Goldberg 1993)). This questionnaire is validated. Four weeks post-injury • Blood cytokine levels. • Hair cortisol levels. • Brain network connectivity.</p><br>