Long-term outcome after mild Traumatic Brain Injury in elderly and its relation with changes in brain network connectivity and cognitive ageing

Long-term outcome after mild Traumatic Brain Injury in elderly and its relation with changes in brain network connectivity and cognitive ageing - mTBI in elderly

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46718

Enrollment

320

Registered

2018-03-06

Start date

2018-11-19

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

traumatisch schedel-hersenletsel contusion mild traumatic brain injury

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results