Fatigue and brain function in young people after brain injury

Characterising fatigue phenotypes and their neural underpinnings in children and young people with acquired brain injury

Registry ID
ISRCTN97876700
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
University of Birmingham
Enrollment
60
Start date
2026-05-01
Completion date
2029-03-01
Last update
2026-08-17

Conditions

Summary

Cognitive fatigue in children and young people (CYP) with acquired brain injury (ABI)

Detailed description

Experimental design: We will recruit a convenience sample of 40 children and young people (CYP) with acquired brain injury (ABI). Prior to enrolment in the study, members of their direct care team will identify potential participants and confirm eligibility against inclusion/exclusion criteria, which will include confirmation of the medical safety of the procedures for MRI. After getting the informed consent and assent, the recruited CYP with ABI will be seen for the following procedures: 1. MRI session including structural and functional sequences (at rest) 2. Demographics and medical history interview: collect relevant demographics and medical history and clinical findings. 3. Clinical assessment: 3.1. Paediatric Quality of Life Multi-dimensional Fatigue Scale (PedsQL-MFS), completed by both parents/carer (about the child) and participant (self-reported) 3.2. Sleep Disturbance Scale for Children 3.3. Cognitive assessment platform: Participants will complete the Cognitron battery We will also recruit a small convenience sample of 20 typically developing CYP (control group) who will undergo the same assessments described above for the CYP with ABI except for clinical assessment. Data analyses: Group differences: Analysis will be conducted according to group allocation. The baseline characteristics of the participants will be summarised using descriptive statistics by groups, n (%) for binary and categorical variables and mean (SD)/median (QIR) for continuous variables. We will run case-control comparisons to confirm differences between the groups in our variables of interest, and correlations and mediation analyses to understand the relationship between cognitive, fatigue and sleep variables across the groups. We will also do clustering analysis to explore whether different phenotypes can be identified. Neural correlates: With the MRI data, the research team will compute measures of functional and structural connectivity, global and regional volume/atrophy and thi

Interventions

Inclusion criteria

Children and young people (CYP) with ABI: 1. Fatigue problems (self-reported, parent-reported or clinical findings) due to moderate to severe ABI 2. Receiving follow-up care at Birmingham Children's Hospital (BCH), with a consensus clinical diagnosis of ABI from any aetiology (i.e. traumatic or non-traumatic injury or oncology) Control participants: 1. Typical developmental history 2. No known history of neurological conditions 3. Free from any medical conditions that required medical or surgical intervention within the last 6 months Both groups: 1. Aged between 10 and 18 years 2. Ability to communicate verbally or non-verbally with their parents and researchers if they don’t feel comfortable or report any problems while undergoing MRI 3. Commitment to engage in the assessments 4. CYP with neurodiversity (e.g., autism, attention deficit hyperactive disorder) diagnosis will be considered if parents feel that they can undergo the assessments

Exclusion criteria

Control participants: 1. History of neurological conditions 2. History of neurodevelopmental conditions Both groups: 1. Suspected or confirmed alcohol/recreational substance use 2. Suspected or confirmed pregnancy 3. Parents who lack the capacity to consent 4. MRI incompatible: metal plates incompatible with MRI scanners, pacemakers, inability to lay flat for prolonged periods, aneurysm clips, neurostimulators, brain/subdural electrodes, etc

Locations

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