of-1 Trials of Stimulant (dexamphetamine or methylphenidate) vs Placebo for Paediatric Traumatic Brain Injury

Phase 3

Recruiting

• Conditions: Traumatic Brain Injury; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12609000865213
• Lead Sponsor: Motor Accident Insurance Commission

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 52

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 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
To determine whether Stimulant therapy with methylphenidate (MPH) or dexamphetamine compared to placebo will significantly improve attention and concentration, and executive dysfunction including disorders of behavioural and emotional regulation, in children with Traumatic Brain Injury (TBI). <br><br>This will be measured using the Conners Teacher and Parent self-reported revised short form ratings scales, and The Goal Attainment Scale.[At the end of each treatment period. Each treatment period will last for one week. There will be a total of six consecutive treatment periods.]

Secondary Outcome Measures

Name	Time	Method
Fatigue. As measured by the Brief Fatigue Inventory.[At the end of each treatment period.<br>Each treatment period will last for one week. There will be a total of six consecutive treatment periods.];Side effects of the drugs. As measured by the modified Barkley Side Effects Questionnaire[At the end of each treatment period. Each treatment period will last for one week. There will be a total of six consecutive treatment periods.]