TerminatedPhase 4ACTRN12612000484842

Efficacy of methylphenidate and Attention Process Training in traumatic brain injury rehabilitation

The effect of methylphenidate and Attention Process Training versus placebo on neuropsychological measures of speed of information processing, complex attentional functioning, and everyday attentional behaviour following moderate to severe traumatic brain injury

Sponsor

Monash University

Enrollment

160 participants

Start Date

Aug 28, 2012

Study Type

Interventional

Conditions

Traumatic Brain Injury (TBI)

Summary

The aim of this study is to investigate the efficacy of methylphenidate combined with individualised Attention Process Training (APT-3) in enhancing performance on neuropsychological measures of speed of thinking, complex attentional functions, and everyday attentional behaviour in a seven week randomised, placebo-controlled drug trial, with functional follow-up at 6 months. A secondary aim is to identify which factors, including injury severity and baseline attentional performance, will be associated with response to Attention Process Training and methylphenidate interventions.

Eligibility

Sex: Both males and femalesMin Age: 16 YearssMax Age: 60 Yearss

Inclusion Criteria4

Traumatic brain injury:
Moderate to severe traumatic brain injury within the preceding 12 months and demonstrated attentional impairment.
Healthy controls:
Recruited from the general population.

Exclusion Criteria4

Traumatic Brain Injury:
Inadequate English, physical abilities or cognitive abilities to complete the tasks or training, past history of treatment for drug or alcohol dependence, previous neurological history, treatment with medications for which methylphenidate is contraindicated, or current medical conditions for which methylphenidate is contraindicated.
Healthy controls:
Inadequate English, physical abilities or cognitive abilities to complete the tasks, a history of neurological or psychiatric trauma or illness, a history of treatment for attentional difficulties or disorders including Attention Deficit Hyperactivity Disorder.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Arm 1 – TBI- Methylphenidate and Attention Process Training Arm 2 – TBI- Methylphenidate Arm 3 – TBI- Attention Process Training and Placebo Arm 4 – TBI- Placebo Arm 5 – Healthy control participants Methylphenidate will be Ritalin LA capsules equivalent to a dose of Ritalin IR (immediate release) 0.3 mg/kg twice daily (bid). A maximum daily upper limit will be set at 60 mg bid. Lactose in identical capsules will serve as placebo. Methylphenidate and placebo will be administered daily at 8am for 7 weeks. A qualified clinical neuropsychologist will deliver the computer-based Attention Process Training (including strategy training). Attention Process Training is an attention training program that consists of a series of computer-based visual and auditory exercises designed to rehabilitate attention deficits. Attention Process Training exercises include tasks such as matching clock times, listening for two numbers amongst a sequence, watching for multiples of 3, and matching faces and emotions. The tasks start off quite easy and get progressively more challenging as the participant demonstrates that they have mastered that skill. Attention Process Training sessions will last for 45 minutes and will occur three times a week for 6 weeks. In week 1 all participants (arms 1-5) will complete a baseline assessment. The healthy control participants (arm 5) will only complete the baseline assessment with results used to further delineate the types and severity of attention deficits following traumatic brain injury. The traumatic brain injury patients (arms 1-4) will then take the drug (methylphenidate or placebo) for 7 weeks. Participants in arms 1 and 3 will receive Attention Process Training for 6 weeks. Two assessments will occur in week 8 (on the drug) and week 9 (drug-free). A follow-up assessment will occur at 6-months.