NL-OMON50090CompletedNot Applicable
A novel integrated perspective linking physiological and psychological consequences of mild traumatic brain injury. - AIM-TBI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 700
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
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 <= 30 minutes (Kayd et al. 1993). Inclusion
- •criteria for the orthopedic control group are patients aged 18 years or older
- •who sustained a minor injury to an extremity (e.g. sprain or uncomplicated
- •fracture of wrist or ankle.
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.
Investigators
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