Overview

Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits in Children

Status:
Completed
Trial end date:
2019-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Vanderbilt University
Collaborator:
Shire
Treatments:
Lisdexamfetamine Dimesylate
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.