None listed
Conditions
Brief summary
The research aims to learn more about the potential benefits of methylphenidate (Ritalin) as people recover from traumatic brain injury. Ritalin is a stimulant medication, most-widely known for its use in children with Attention Deficit Hyperactivity Disorder. It works by increasing the concentrations of certain neurotransmitters within the brain, especially those involved in attentional processes. Past studies have shown that methylphenidate has been effective in patients with a traumatic brain injury in improving attention. This study looks at whether it not only improves attention but also day to day function and sense of well-being after three months.
Interventions
3-month randomised double-blind placebo-controlled trial with oral active or placebo medication (Methylphenidate, Ritalin long acting 10mg DAILY for the first 7 days, to be increased to 20mg DAILY for 5 days) to be administered over 12 days and followed up for 3 months to assess outcomes. The medication will be administered by registered nursing staff on inpatient Brain Injury Unit.The principal researchers (Drs Browne and Bui) or MD Medical students will be undertaking assessments of attention
3-month randomised double-blind placebo-controlled trial with oral active or placebo medication (Methylphenidate, Ritalin long acting 10mg DAILY for the first 7 days, to be increased to 20mg DAILY for 5 days) to be administered over 12 days and followed up for 3 months to assess outcomes. The medication will be administered by registered nursing staff on inpatient Brain Injury Unit.The principal researchers (Drs Browne and Bui) or MD Medical students will be undertaking assessments of attention and cognition as well as participation, mood and quality of life measures. All participants will be given a baseline assessment and then undergo further assessments after administration of either active or placebo medication.
Sponsors
Royal Rehab
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
A participant is identified to be eligible if they are aged between 18-65yo, have a new traumatic brain injury within the past 6 months, a measurable PTA of greater than 7 days. All participants need to be able to give informed consent.
Exclusion criteria
Non-English speaking Dysphasia Current treatment with psycho-active medications cardiac events hypertension abnormal ECG tics post-traumatic seizures pregnancy (negative bhCG) prior history of alcohol or drug abuse Any medications which are contra-indicated with MPD: monoamine oxidase inhibitors, clonidine, dopamine agonists or antagonists, certain anaesthetics
Outcome results
None listed