A series of n-of-1 trials of stimulants in brain injured children

Nikles, Jane, Mitchell, Geoffrey, McKinlay, Lynne, Waugh, Mary-Clare, Epps, Adrienne, Carmont, Sue-Ann, Schluter, Philip J. , Lloyd, Owen and Senior, Hugh (2017) A series of n-of-1 trials of stimulants in brain injured children. NeuroRehabilitation, 40 1: 11-21. doi:10.3233/NRE-161386

Author Nikles, Jane
Mitchell, Geoffrey
McKinlay, Lynne
Waugh, Mary-Clare
Epps, Adrienne
Carmont, Sue-Ann
Schluter, Philip J.
Lloyd, Owen
Senior, Hugh
Title A series of n-of-1 trials of stimulants in brain injured children
Journal name NeuroRehabilitation   Check publisher's open access policy
ISSN 1878-6448
Publication date 2017-03-01
Sub-type Article (original research)
DOI 10.3233/NRE-161386
Open Access Status Not yet assessed
Volume 40
Issue 1
Start page 11
End page 21
Total pages 11
Place of publication Amsterdam, Netherlands
Publisher I O S Press
Collection year 2018
Language eng
Formatted abstract
Background: There is controversy about whether central nervous system stimulant (CNS) medication is an effective method of treating acquired attention deficits in children with acquired brain injury (ABI).

Objective: The primary objective was to determine the effectiveness of stimulants on attention, concentration and executive function in children with ABI.

Methods: Randomised, double-blind, placebo-controlled, multi-centre n-of-1 trials of stimulants assessing effect on attention, concentration and executive function in 53 children and adolescents with ABI who were outpatients of three tertiary hospitals in Australia. Trials consisted of 3 two-week cycles, each cycle consisting of stimulant medication at doses titrated by physician (1 week) and placebo (1 week) in random order. The effect on parent and teacher Conners' 3 and Behaviour Rating Inventory of Executive Function (BRIEF) was analysed using hierarchical Bayesian methods.

Results: Overall, Teacher Conners' Hyperactivity/Impulsivity and Teacher BRIEF Global Executive scales showed important improvement (T-score mean change 2.6; 95 credible interval (CI): 0.4, 4.9; posterior probability of mean change >0:0.99; T-score mean change 3.1; 95 CI: -0.1, 6.4; posterior probability of mean change >0:0.97). There were no important improvements in parent/guardian-reported primary outcomes. There was heterogeneity in response identified through individual results of the N-of-1 trials.

Conclusions: N-of-1 trials have a clear role in identifying those children/adolescents with ABI and secondary Attention Deficit Hyperactivity Disorder (ADHD) who have important improvements, or worsening on stimulants. The results can only be generalized to children/adolescents who have an apparent pre-trial clinical effect from stimulants.
Keyword Acquired brain injury
Traumatic brain injury
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: UQ Centre for Clinical Research Publications
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