None listed
Conditions
Brief summary
Traumatic brain injury (TBI) results in disabling impairments of attention and speed of information processing, which prevent patients from returning to previous life roles. Methylphenidate primarily acts upon dopaminergic and noradrenergic neurotransmitter systems which mediate attentional processes, and are disrupted by TBI. Previous treatment study findings with methylphenidate have been mixed, and many have recruited patients many years post-injury. This study aims to investigate the efficacy of methylphenidate in the amelioration of attention deficits during the acute rehabilitation phase. Forty participants with TBI and 40 healthy controls were seen for a one-off two hour baseline assessment session in order to identify the nature of attentional impairment following TBI. The TBI group were then recruited into the randomised, crossover, placebo controlled drug trial of two weeks duration.
Interventions
Methylphenidate hydrochloride.
Oral administration of compounded product in opaque gelatin capsules identical to comparator.
Dose 0.3 mg/kg twice daily (8am & 12pm).
There are 6 trial days (Mon, Wed, Fri) over a two week period. The 6 sessions are divided into three blocks: Days 1 & 2, Days 3 & 4, Days 5 & 6. One session of each block is randomly assigned as a methylphenidate session and the other as a placebo session. The methylphenidate & placebo are each administered on 3 out of the 6 trial d
Methylphenidate hydrochloride. Oral administration of compounded product in opaque gelatin capsules identical to comparator. Dose 0.3 mg/kg twice daily (8am & 12pm). There are 6 trial days (Mon, Wed, Fri) over a two week period. The 6 sessions are divided into three blocks: Days 1 & 2, Days 3 & 4, Days 5 & 6. One session of each block is randomly assigned as a methylphenidate session and the other as a placebo session. The methylphenidate & placebo are each administered on 3 out of the 6 trial days.
Sponsors
Ms. Catherine Willmott
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
-History of moderate-severe traumatic brain injury sustained within the previous 12 months -Current inpatient on Acquired Brain Injury (ABI) ward of Epworth Rehabilitation -Demonstrated attentional impairment as indicated on the Symbol Digit Modalities Test -Adequate physical and cognitive abilities and understanding of English to complete neuropsychological tasks
Exclusion criteria
-Past neurological history -Past treatment for drug/alcohol dependence -Current treatment with psychoactive medications likely to interact with methylphenidate
Outcome results
None listed