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

A novel integrated perspective linking physiological and psychological consequences of mild traumatic brain injury. - AIM-TBI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50090

Enrollment

700

Registered

2019-04-17

Start date

2020-01-17

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

concussion

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria are: patients with mild traumatic brain injury (mTBI) aged 18 years or older. Mild TBI is defined by a Glasgow Coma Scale score of 13-15 and/or loss of consciousness

Exclusion criteria

Exclusion criteria: Exclusion criteria for mTBI are: neurological or psychiatric co-morbidity, admission for prior TBI, drug or alcohol abuse, and mental retardation. For the orthopedic controls and healthy controls exclusion criteria are: neurological or psychiatric co-morbidity, previous TBI, drug or alcohol abuse, and mental retardation. Exclusion criteria for the MRI-study are implanted ferromagnetic devices or objects, pregnancy or claustrophobia. Language barriers or illiteracy, prohibiting understanding and completion of questionnaires are general exclusion criteria.

Design outcomes

Primary

Measure	Time frame
- Post-traumatic complaints (measured using the head injury symptom checklist (HISC) at 6 months post-injury). - Glasgow Outcome Scale Extended (GOSE) at 6 months post-injury.	—

Secondary

Measure	Time frame
Secondary parameters: - Blood cytokine levels at the ED and at 4-6 weeks post-injury. - Blood biomarker levels (proteins of cell injury) at the ED. - Salivary cortisol levels at the ED. - Hair cortisol levels at 4-6 weeks post-injury. - Heartrate variability at the ED. - EEG at the ED, and at 4-6 weeks post-injury. - Brain network connectivity at 4-6 weeks post-injury. - HISC at 2 weeks post-injury. - Anxiety/depression at 2 weeks post-injury (Hospital Anxiety and Depression Scale (HADS)). - Coping (Utrechtse Coping List (UCL) at 2 weeks post-injury). - Personality characteristics (Big Five Inventory (BFI) at 2 weeks post-injury). Other parameters: - Baseline parameters (age, sex, educational level, pre-injury working status, injury characteristics, CT-abnormalities, acute complaints). - Pre-injury mental health state and stress. - Lifestyle factors (alcohol and caffeine consumption, tobacco use, exercise).	—

Measure

Time frame

Secondary parameters: - Blood cytokine levels at the ED and at 4-6 weeks post-injury. - Blood biomarker levels (proteins of cell injury) at the ED. - Salivary cortisol levels at the ED. - Hair cortisol levels at 4-6 weeks post-injury. - Heartrate variability at the ED. - EEG at the ED, and at 4-6 weeks post-injury. - Brain network connectivity at 4-6 weeks post-injury. - HISC at 2 weeks post-injury. - Anxiety/depression at 2 weeks post-injury (Hospital Anxiety and Depression Scale (HADS)). - Coping (Utrechtse Coping List (UCL) at 2 weeks post-injury). - Personality characteristics (Big Five Inventory (BFI) at 2 weeks post-injury). Other parameters: - Baseline parameters (age, sex, educational level, pre-injury working status, injury characteristics, CT-abnormalities, acute complaints). - Pre-injury mental health state and stress. - Lifestyle factors (alcohol and caffeine consumption, tobacco use, exercise).

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Countries

Netherlands

Outcome results