A novel integrated perspective linking physiological and psychological consequences of mild traumatic brain injury.
- Conditions
- concussionheadtrauma.1004225810009841
- Registration Number
- NL-OMON50090
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 700
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 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Post-traumatic complaints (measured using the head injury symptom checklist<br /><br>(HISC) at 6 months post-injury).<br /><br>- Glasgow Outcome Scale Extended (GOSE) at 6 months post-injury. </p><br>
- Secondary Outcome Measures
Name Time Method