Methylphenidate (Ritalin) and Memory/Attention in Traumatic Brain Injury (TBI)
Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)