Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits
Condition: Traumatic Brain Injury; Attention Deficit Disorder
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Attention Deficit Disorder with Hyperactivity
Intervention: Vyvanse; fMRI; Placebo
Intervention description: 30 mg - 70 mg capsules taken every morning for 6 weeks.; Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.; Placebo capsules taken every morning for 6 weeks.
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 16 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Traumatic Brain Injury; Attention Deficit; TBI

Summary:

      The purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can
      help with attention deficits due to traumatic brain injury (TBI). Vyvanse is currently
      approved for the treatment of Attention-Deficit/Hyperactivity (ADHD). The exact effects this
      drug may have on attention deficits caused by TBI are not known, but we expect that Vyvanse
      will be of some help in treating those types of problems as well. The study will utilize
      functional magnetic resonance imaging (fMRI) methods, as well as neurobehavioral measures, to
      elucidate neural mechanisms of response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, ages 16 to 45

          -  Closed head injury rated as moderate/severe (based on Glasgow Coma Scale rating,
             estimated posttraumatic amnesia, etc.)

          -  Sustained 6 to 36 months earlier, and considered to be neurologically stable

          -  Persistent (> 6 months) problems with focused or sustained attention (+1 SD or worse
             on Inattention component of ADHD self ratings) corroborated by professional staff
             (nurses, therapists, etc.) or caregivers. Problems with attention/concentration rated
             as among most prominent cognitive changes.

          -  Accompanying features may include diminished arousal/speed/stamina and/or disinhibited
             symptoms

        Exclusion Criteria:

          -  Penetrating head injury

          -  Pre-injury history of diagnosed ADHD

          -  Other psychiatric conditions such as mania or psychosis. Current posttraumatic stress
             disorder (PTSD) symptoms may be present but not so severe as to require pharmacologic
             treatment.

          -  Lifetime history of psychostimulant abuse or dependence. Other (non-psychostimulant)
             substance abuse within the past 6 months. Total lifetime drug use will not exceed 5
             times each for substances such as amphetamine, meth-amphetamine, or cocaine.

          -  Prior treatment with psychostimulant(s)

          -  Tics or other contraindications for psychostimulant use including arteriosclerosis,
             cardiovascular disease, uncontrolled hypertension or hyperthyroidism, glaucoma,
             agitation, use of MAO inhibitor within 6 weeks

          -  Current treatment with other psychotropic medication(s) within the past 6 weeks

          -  Estimated IQ < 80

          -  Sensory and/or motor impairment(s) seriously limiting testing options

          -  Other neurological conditions including epilepsy, degenerative disorders, brain tumor,
             or stroke.

          -  Physical conditions affecting arousal, activity level or stamina, including
             uncontrolled thyroid dysfunction, anemia, autoimmune or metabolic disorders, untreated
             moderate/severe sleep apnea, etc.

          -  Persons for whom MRI scanning is contraindicated, including weight greater than 275
             pounds (due to scanner table limitations), severe claustrophobia, implanted electronic
             medical devices (e.g. pacemaker, cochlear or other inner ear implant, deep brain
             stimulator), metallic foreign object in eye or rest of the body, history of sheet
             metal work, aneurysm clips, non-removable metallic piercings, and dental prosthetics.