Primary Objective: • To investigate whether or not persistent complaints and poor outcome after mTBI be explained by an interaction between physiological and psychological factors. In other words, the aim is to investigate whether a more optimal…
ID
Source
Brief title
Health condition
mild traumatic brain injury
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• 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 outcome
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.
Background summary
Mild traumatic brain injury (mTBI) is the most common neurologic disorder. One out of 4 patients develops long-lasting cognitive and emotional complaints that interfere with daily functioning. Therefore, mTBI poses a significant public health burden. Over the years multifactorial models have been developed, which aid in the prediction of outcome after mTBI. It has been shown that in addition to acute injury related factors, such as loss of consciousness and amnesia, outcome is strongly influenced by pre-existent psychological factors, for instance coping style and emotion regulation. Despite these scientific efforts, persistent complaints are still rather unpredictable in individual patients, for whom injury mechanisms are often comparable. So far, little is known about the influence of physiological effects of the injury, such as cellular injury, neuroinflammation, and acute stress, on outcome after mTBI. Previous functional MRI (fMRI) research has demonstrated that persistent complaints after mTBI are related to alterations in neural networks. Therefore, a pivotal question is whether acute physiological effects lead to disturbances in neural networks that are important for emotion regulation, and if there is an interaction with pre-existent personality, coping style, and stress levels, This topic has never been touched upon, and therefore forms a gap in mTBI research. With the current study, we aim to conduct biochemical, psychometric and MRI-experiments in order to disentangle the interaction(s) between (acute) physiological and (long-term) psychological consequences of TBI. Hopefully, this will lead to a better understanding of the etiology of persistent complaints and poor outcome, and to starting points for the development of tailored pharmacological and/or psychological treatments for patients with mTBI.
Study objective
Primary Objective: • To investigate whether or not persistent complaints and poor outcome after mTBI be explained by an interaction between physiological and psychological factors. In other words, the aim is to investigate whether a more optimal model based on a combination of abovementioned factors can be developed, in comparison to models based on either physiological or psychological factors. Secondary Objective(s): • To identify specific patterns of brain specific protein, cortisol and cytokine release and HRV, as markers of acute brain damage or alteration of physiological processes in patients with mTBI. • To determine if patients with mTBI differ in cortisol and cytokine release from patients with another stressful condition (i.e. orthopedic injury), and healthy controls. • To find possible relationships between acute physiological disturbances (inflammation, stress) and altered activity/connectivity of neural networks in mTBI, and to determine whether or not this is related to psychological factors.
Study design
4
Age
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: 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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8484 |
| Other | METc UMCG : METc 2018/681 |