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

Vanderbilt University

Status and phase

Completed

Phase 4

Conditions

Attention Deficit Disorder

Traumatic Brain Injury

Treatments

Drug: Lisdexamfetamine

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02712996

TBI 56592

Details and patient eligibility

About

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.

Full description

Symptoms of inattentiveness, impulsivity, and poor persistence have been observed in children following traumatic brain injury (TBI). These often are among the most prominent symptoms manifested and may contribute to interference in a variety of other functional domains. Although there has been some use of psychostimulant medication to treat TBI-acquired attention deficits, it remains a relatively uncommon clinical practice. This study, by highlighting mechanisms of action, could serve to promote the appropriate use of this type of treatment for the patients.

Enrollment

20 patients

Sex

All

Ages

6 to 16 years old

Volunteers

Accepts Healthy Volunteers

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.