Acute Injury Markers in mTBI

A novel integrated perspective linking physiological and psychological consequences of mild traumatic brain injury

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24795

Enrollment

700

Registered

2020-03-28

Start date

2020-01-17

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

mild traumatic brain injury

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
• 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.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Contacts

Public ContactHarm Jan Van der Horn

UMCG

h.j.van.der.horn@umcg.nl0031610037485

Outcome results