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

NCT ID: NCT02712996

Last Updated: 2020-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-06
• Study Completion Date: 2019-07-01

Brief 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.

Detailed 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.

Conditions

Traumatic Brain Injury; Attention Deficit Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Vyvanse

Lisdexamfetamine (Vyvanse) capsule, 20-70 mg, each morning for 6 weeks.

Group Type: ACTIVE_COMPARATOR

Lisdexamfetamine

Intervention Type: DRUG

Lisdexamfetamine (Vyvanse) capsule, 20-70 mg, each morning for 6 weeks.

Placebo

Placebo capsule, 20-70 mg, each morning for 6 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsule, 20-70 mg, each morning for 6 weeks.

Interventions

Lisdexamfetamine

Lisdexamfetamine (Vyvanse) capsule, 20-70 mg, each morning for 6 weeks.

Intervention Type: DRUG

Placebo

Placebo capsule, 20-70 mg, each morning for 6 weeks.

Intervention Type: DRUG

Other Intervention Names

Vyvanse

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shire

INDUSTRY

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Michael G. Tramontana, Ph.D.

Associate Professor of Psychiatry and Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael G Tramontana, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Vanderbilt Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TBI 56592

Identifier Type: -

Identifier Source: org_study_id