Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits in Children
Condition: Traumatic Brain Injury; Attention Deficit Disorder
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Attention Deficit Disorder with Hyperactivity
Intervention: Lisdexamfetamine; Placebo
Intervention description: Lisdexamfetamine (Vyvanse) capsule, 20-70 mg, each morning for 6 weeks.; Placebo capsule, 20-70 mg, each morning for 6 weeks.
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 6 Years
Maximum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Traumatic Brain Injury; Attention Deficit; TBI; Vyvanse

Summary:

      The purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can
      help children ages 6-16 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 adults with attention deficits caused by TBI have been
      investigated prior. The exact effects this drug may have on children with attention deficits
      caused by TBI are not known, but the investigators expect that Vyvanse will be of some help
      in treating this population as well.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females ages 6 to 16

          -  Traumatic brain injury rated as mild/moderate/severe (based on Glasgow Coma Scale,
             estimated posttraumatic amnesia, indications of intracranial injury on CT scan, etc.)

          -  Sustained 2-36 months earlier

          -  Considered to be neurologically stable (absence of post-acute symptoms of confusion,
             disorientation, etc.)

          -  Persistent (> 2 months) problems with focused or sustained attention

          -  Problems with attention/concentration rated as among the most prominent cognitive
             changes

          -  Accompanying features may include diminished arousal/speed/stamina and/or
             hyperactivity/impulsivity symptoms.

        Exclusion Criteria:

          -  Cases with primarily penetrating head trauma

          -  Pre-injury history of diagnosed ADHD

          -  Pre-injury history of other neurodevelopmental disorders including intellectual
             disabilities, major communication disorders, autism spectrum disorder

          -  Unstable or serious psychiatric conditions, such as psychotic symptoms. Concurrent
             problems with depression, anxiety, or post-traumatic stress disorder may be present
             but are judged to be stable and not so severe as to require pharmacologic treatment

          -  Treatment with psychotropic medication(s), including psychostimulant(s) within the
             last 6 months, but eligible thereafter

          -  Lifetime history of stimulant abuse or dependence. Other (non-stimulant) substance
             abuse within the past 6 months.

          -  Tics or other contraindications for psychostimulant use including cardiovascular
             disease, uncontrolled hypertension or hyperthyroidism, glaucoma, agitation, use of an
             monoamine oxidase (MAO) inhibitor within the past six weeks. Pregnancy would also be
             an exclusion for girls of childbearing age.

          -  Estimated intelligence quotient (IQ) < 70

          -  Sensory and/or motor impairment(s) seriously limiting testing options

          -  Neurological conditions including uncontrolled epilepsy, degenerative disorders, brain
             tumor, or stroke

          -  Physical condition affecting arousal, activity level, or stamina including
             uncontrolled thyroid dysfunction, severe or symptomatic anemia, autoimmune or
             metabolic disorders, untreated moderate/severe sleep apnea, etc.