Primary objective: To study the relation between cognitive and physical recovery after mTBI in elderly and long-term psychosocial functioning and quality of life. Secondary objective: To study the effect of mTBI in elderly as external stressor on…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
traumatisch schedel-hersenletsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For all patients measures of cognitive and physical functioning, will be taken
using questionnaires at several time points. The following time line is
considered: T0) baseline, admission to the ED or ward, T1) 1 week, T2) 4-6
weeks, T3) 3 months after injury and T4) 6 months after injury.
For the observational study the main parameter is the outcome determined 3
months after injury using the Glasgow Outcome Scale Extended and WHO scale
Quality of Life questionnaires.
Secondary outcome
As secondary outcome measure the unmet needs are explored together with the
level of social participation by questionnaires.
In the Connectivity add-on study acute and longitudinal changes in brain
network connectivity will be assessed by multi-channel electroencephalography
(EEG) at T0, T2 and T3. Add-on functional magnetic resonance imaging (fMRI) is
only performed at T2 for between modality comparison across the whole spectrum
of older mTBI patients at this time-point.
Background summary
Traumatic brain injury (TBI) is one of the most important causes of morbidity
and mortality in adults. Mild TBI (mTBI) accounts for 85% of cases and 15-20%
of those patients suffer from persistent complaints that interfere with
resumption of daily activities. The number of elderly sustaining a TBI is
increasing due to growing life expectancy and now comprises 20% of all TBI
hospital admissions. The majority of TBI in the elderly is caused by a fall and
related to high health care costs. Concomitant brain injury is often not
reported, although repetitive head injury is related to worsening of symptoms,
cognitive decline and dementia. Yet, the effect of mild TBI on cognitive and
physical functioning and its relation with long-term psychosocial functioning
and quality of life in elderly patients who are more vulnerable to develop
persistent complaints in view of age-related cognitive decline has scarcely
been investigated.
Study objective
Primary objective: To study the relation between cognitive and physical
recovery after mTBI in elderly and long-term psychosocial functioning and
quality of life.
Secondary objective: To study the effect of mTBI in elderly as external
stressor on the course of age-related cognitive decline and the development of
persistent complaints in relation to acute and long-term brain network
connectivity changes.
Study design
A prospective observational cohort study with an add-on Connectivity study
comprising a longitudinal EEG-measurement and an fMRI cross-sectional
measurement at first follow-up.
Study burden and risks
Measurements in this study do not have adverse consequences for those involved,
and there are no risks associated with participation, provided the exclusion
criteria for fMRI are taken into account. The burden of participation is mainly
restricted to the time involved in the measurements. There are no direct
benefits for participants.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
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)
Exclusion criteria
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64491.042.17 |