of-1 trials to evaluate the effect of stimulant vs placebo in pediatric traumatic brain injury

Recruiting

• Conditions: Traumatic brain injury in children; Neurological - Other neurological disorders; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12609000873224
• Lead Sponsor: The Univesity of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1) Any school age (6-16 years) patient with a clinical diagnosis of moderate to severe brain injury who is at least 12 months post injury. Severity criteria are based on Glasgow coma scale (GCS) criteria ie for moderate traumatic brain injury (TBI) = GCS of 9-13 at presentation to the treating hospital and severe TBI = initial GCS 3-8/15. 2) The child has a clinically significant attention/concentration disorder or executive dysfunction including disorders of behavioural or emotional regulation that may respond to stimulants. 3) Patient, parent and doctor would like to use the n-of-1 trial methodology to see if the patient is a true responder to the stimulant. 4) Patients and parents are willing to consent and participate, and to continue treatment with the medication if it is shown to be effective in their case. 5) The patient is in a community setting. 6) At least two people (parent and teacher or other person) are available to monitor the child’s symptoms.

Exclusion Criteria

Uncontrolled seizure disorder, moderate to severe hypertension, clinically significant anxiety, motor tics, Tourette syndrome, suspected or proven cardiac conduction problems, idiosyncratic reaction to sympathomimetic amines, history of drug abuse (including high caffeine beverages and appetite suppressants). Parents not able to fill out forms in English.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a) Conners Teacher and Parent self-reported revised short form rating scales (8, 9). A self report scale for those over 12 years whose clinicians decide they are able to fill out the forms will also be available (Conners-Wells adolescent rating scales). These will measure overall ADHD index scores as well as scores for cognitive problems/attention, hyperactivity and oppositional scores.[At baseline and at the end of each week,];There will be a weekly diary containing questions about side effects,[At baseline and at the end of each week,];There will be a weekly diary containing questions about medication guesses[At baseline and at the end of each week,];Medication preferences[At baseline and at the end of each week];observer comments[At baseline and at the end of each week]

Secondary Outcome Measures

Name	Time	Method
A shortened 3-question version of the Brief Fatigue Inventory (BFI) will be used to monitor fatigue.[The BFI will be measured via self-report at baseline and at the end of each week, along with the weekly diaries mentioned above.]