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Working memory training for children who have survived a brain injury
ISRCTN ISRCTN01872582
DOI 10.1186/ISRCTN01872582
ClinicalTrials.gov identifier
EudraCT number
Public title Working memory training for children who have survived a brain injury
Scientific title An evaluation of computerised working memory training in children who have survived a brain injury
Acronym N/A
Serial number at source 13091
Study hypothesis Executive functions, including working memory, are of central importance for controlling human behaviour and social functioning. Research indicates that working memory (WM, e.g., a cognitive system used for short-term storage and manipulation of information) impairments are frequently reported following paediatric acquired brain injury (ABI) and contribute to detrimental consequences of injury in everyday life. Interventions intended to improve executive functions, particularly working memory, in this population might therefore serve an important purpose in rehabilitation of affected functions. However, still little is known about the profile of WM impairments in survivors of childhood ABI and consequently there is a lack of effective evidence-based interventions. Previous studies have shown that working memory ability can be improved by computerised training (Cogmed RM, 2006) in pre-school children and children with low WM capacity, and that training gains can generalise to the other cognitive functions (including mathematical ability).

To date, the usefulness of this intervention for children who have survived an ABI has yet to be investigated. This study therefore, has five aims: i) to investigate the feasibility and acceptability of a home-based computerised WM training programme (Cogmed RM) for children with an ABI and their parents; ii) to investigate whether WM capacity will improve with training; and iii) to investigate whether training effects transfer to other cognitive functions (e.g., executive function and attention) and functional abilities (e.g., academic performance, classroom engagement and participation), and reduce perceived family burden and improve the patients’ quality of life); iv) to evaluate whether working memory training reduces health costs; and v) to extend these findings to a larger sample of 90 children with traumatic brain injury (TBI). This study will employ a randomised controlled parallel design.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13091
Lay summary Not provided at time of registration
Ethics approval First MREC approval date 01/02/2012, ref: 11/EE/0434
Study design Randomised controlled parallel interventional study; Design type: Treatment
Countries of recruitment United Kingdom
Disease/condition/study domain Topic: Neurological, Generic Health Relevance and Cross Cutting Themes; Subtopic: Neurological (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Nervous system disorders, Paediatrics
Participants - inclusion criteria Potential participants for intervention and placebo group will:
1. Male & Female, aged between 8 and 16 years.
2. Score at or below the 30th centile on two tasks of verbal WM, listening recall and backward digit recall, from the Automated Working Memory Assessment (AWMA, Alloway, 2007).
3. Be medically stable.
4. Be computer literate, and will have access to a computer and the internet.
5. Speak English.

For the feasibility/acceptability pilot: participants will have documented evidence of non-progressive ABI, defined as a TBI, stroke, herpes encephalitis, and infratentorial tumour with resection or cranial radiotherapy.

For the full study: participants will have documented evidence of non-progressive TBI and will be survivors of moderate (Glasgow Coma Scale (GCS) 8 – 12, Post Traumatic Amnesia (PTA 1 – 24 hours) to severe (GCS < 8, PTA > 24 hours) brain injury.
Participants - exclusion criteria Participants will be excluded if:
1. There is evidence of severe damage to organs other than the brain, major medical problems, or the presence of significant mood disturbance.
2. There is evidence of a progressive neurodegenerative condition.
3. There is a pre-morbid history of learning disability or a specific learning impairment affecting working memory (e.g., dyslexia, specific language impairment), conduct disorder, current use of medication impacting on cognition, or a lack of English proficiency.
Anticipated start date 01/09/2012
Anticipated end date 31/08/2015
Status of trial Ongoing
Patient information material Parent/guardian information: http://www.uea.ac.uk/documents/134927/0/Parent+information+sheet.pdf/784787cc-cfcf-403c-b196-a943d95fd24a Participant information : http://www.uea.ac.uk/documents/134927/0/Participant+info+sheet+16%2B.pdf/05ca4b08-81ae-487c-bc63-f004c18b005e http://www.uea.ac.uk/documents/134927/0/participant+into+sheet+12%2B.pdf/152537fb-b2fc-4034-ae3a-86256d025770 http://www.uea.ac.uk/documents/134927/0/participant+info+sheet+8%2B.pdf/4549d676-3552-422d-902f-e053386d5372
Target number of participants Planned Sample Size: 138; UK Sample Size: 138
Interventions Working memory training: 5-weeks of computerised working memory training (approximately 30-mins per day for 5 days per week)

Study Entry : Single Randomisation only
Primary outcome measure(s) Working memory performance; Timepoints: immediately post-training, and at 6-months follow-up
Secondary outcome measure(s) Not provided at time of registration
Sources of funding 1. Action Medical Research (UK)
2. British Academy (For the Promotion of Historical Philosophical and Philological Studies)
Trial website http://www.uea.ac.uk/medicine/neuropsychology/research
Publications
Contact name Dr  Anna-Lynne  Adlam
  Address Earlham Road
  City/town Norwich
  Zip/Postcode NR4 7TJ
  Country United Kingdom
  Email a.adlam@uea.ac.uk
Sponsor University of East Anglia (UK)
  Address Earlham Road
  City/town Norwich
  Zip/Postcode NR4 7TJ
  Country United Kingdom
  Sponsor website: http://www.uea.ac.uk/
Date applied 19/07/2013
Last edited 19/07/2013
Date ISRCTN assigned 19/07/2013
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