ong-term outcome after mild Traumatic Brain Injury in elderly and its relation with changes in brain network connectivity and cognitive ageing
- Conditions
- traumatisch schedel-hersenletselcontusionmild traumatic brain injury
- Registration Number
- NL-OMON46718
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 320
Patients:
• Glasgow Coma Scale (GCS) scores on admission from 13-15
• having had loss of consciousness and/or posttraumatic amnesia (PTA)
• 60 years or older
• Comprehension of Dutch language (to understand Dutch questionnaires)
Controls:
• age-matched with patients on group level
• comprehension of Dutch language (to understand Dutch questionnaires)
• (corrected) adequate vision
• 6-item CIT score lower than 11 points (unimpaired cognition)
All participants:
• unavailable for or inability to comply with follow-up
• drug or alcohol addiction
• psychiatric diseases (for which participant was admitted in the past)
• previous TBI (for which participant was admitted in the past)
• fMRI exclusion criteria: claustrophobia, non-MR-compliant implants, metal
fragments in eyes, non-removable piercings
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>For all patients measures of cognitive and physical functioning, will be taken<br /><br>using questionnaires at several time points. The following time line is<br /><br>considered: T0) baseline, admission to the ED or ward, T1) 1 week, T2) 4-6<br /><br>weeks, T3) 3 months after injury and T4) 6 months after injury.<br /><br>For the observational study the main parameter is the outcome determined 3<br /><br>months after injury using the Glasgow Outcome Scale Extended and WHO scale<br /><br>Quality of Life questionnaires. </p><br>
- Secondary Outcome Measures
Name Time Method <p>As secondary outcome measure the unmet needs are explored together with the<br /><br>level of social participation by questionnaires.<br /><br>In the Connectivity add-on study acute and longitudinal changes in brain<br /><br>network connectivity will be assessed by multi-channel electroencephalography<br /><br>(EEG) at T0, T2 and T3. Add-on functional magnetic resonance imaging (fMRI) is<br /><br>only performed at T2 for between modality comparison across the whole spectrum<br /><br>of older mTBI patients at this time-point.</p><br>