At a glance
ClinicalIndex Comparison Record- ✓Age 18–65 years
- ✓Traumatic brain injury sustained ≥4 months before study entry, confirmed by loss of consciousness and/or altered consciousness/amnesia
- ✓Persistent cognitive deficits in memory and/or attention documented by either >2 SD below age-adjusted norm on one test OR >1 SD below norm on ≥2 tests of attention/memory
- ✓Memory or attention deficits of sufficient severity to interfere with social and/or occupational functioning
- ✕History of other neurologic disorders (epilepsy, cerebrovascular disease, mental retardation, neurodegenerative disorders)
- ✕Significant systemic medical illness: clinically significant liver disease, renal disease, atherosclerotic coronary vascular disease, or hypertension requiring medication management
- ✕Current DSM-IV Axis I psychiatric illness other than stable remission from non-stimulant substance abuse
- ✕History of stimulant abuse (cocaine, amphetamines) or other stimulant cross-over abuse risk
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Methylphenidate (Ritalin) and Memory/Attention in Traumatic Brain Injury (TBI)
In Brief
A clinical study evaluating Methylphenidate, Memory and Attention Training, and 1 other intervention for Brain Injury. Completed, enrolled 76 participants across 3 sites.
Detailed Summary
Traumatic brain injury (TBI) is a significant public health problem, with 1.5-2.0 million Americans injured each year. Cognitive deficits, particularly in the domains of memory and attention are frequently the source of lingering disability after TBI and a source of enormous distress to the injured individuals and their family/caregivers. To date, interventions to ameliorate chronic cognitive deficits have been directed at either pharmacological interventions or cognitive rehabilitation. We propose to (1) To compare the efficacy of three interventions: memory and attention training (MAAT), methylphenidate, and memory/attention training in combination with methylphenidate and (2) use functional MRI (fMRI) to characterize changes in activation of the neural circuitry of memory and attention due to MAAT alone, methylphenidate alone, and MAAT in combination with methylphenidate. This is a two by two design with medication (methylphenidate/placebo) and cognitive therapy (Memory and Attention Training (MAAT) or an Attention control intervention) as possible interventions. Using a randomized, placebo-controlled, double-blind design, 200 individuals with persistent cognitive deficits 6-12 months after MTBI will be randomized to receive a six week trial of either (1) MAAT and placebo, (2) MAAT and methylphenidate (0.3 mg/kg BID), (3) attention control intervention and methylphenidate (0.3 mg/kg BID), or (4) attention control intervention and placebo. Symptom distress, attention and memory performance, and activation patterns of the neural circuitry of attention and memory while undergoing fMRI will be characterized at baseline, and after the four treatment conditions. This study will provide important information on three interventions for the most disabling sequelae of an enormous public health problem. Further, it will help to clarify underlying neural mechanisms and suggest additional treatment possibilities.
Study Details
Timeline
Interventions
Dosage dependent on weight
Weekly Memory and Attention Training with at home practice.
Placebo capsules and Placebo Memory and Attention Training