Plain English Summary

Not provided at time of registration

Trial website

http://www.uea.ac.uk/medicine/neuropsychology/research

Contact information

Type

Scientific

Primary contact

Dr Anna-Lynne Adlam

ORCID ID

Contact details

Earlham Road
Norwich
NR4 7TJ
United Kingdom
a.adlam@uea.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13091

Study information

Scientific title

An evaluation of computerised working memory training in children who have survived a brain injury

Acronym

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

Ethics approval

First MREC approval date 01/02/2012, ref: 11/EE/0434

Study design

Randomised controlled parallel interventional study; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Topic: Neurological, Generic Health Relevance and Cross Cutting Themes; Subtopic: Neurological (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Nervous system disorders, Paediatrics

Intervention

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

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Working memory performance; Timepoints: immediately post-training, and at 6-months follow-up

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2012

Overall trial end date

31/08/2015

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 138; UK Sample Size: 138

Participant 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.

Recruitment start date

01/09/2012

Recruitment end date

31/08/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Earlham Road
Norwich
NR4 7TJ
United Kingdom

Sponsor information

Organisation

University of East Anglia (UK)

Sponsor details

Earlham Road
Norwich
NR4 7TJ
United Kingdom

Sponsor type

University/education

Website

http://www.uea.ac.uk/

Funders

Funder type

Charity

Funder name

Action Medical Research (UK)

Alternative name(s)

AMR

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

British Academy (For the Promotion of Historical Philosophical and Philological Studies)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Editorial Notes