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

NCT ID: NCT01000064

Last Updated: 2017-05-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2015-05-31

Brief 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.

Detailed Description

Symptoms of inattentiveness, impulsivity, and poor persistence have been observed in both children and adults 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: DOUBLE

Study Groups

Vyvanse

Vyvanse capsule, 30-70 mg, each morning for 6 weeks.

Placebo capsule each morning for 6 weeks.

Brain scans (fMRI) performed at baseline, 6th week visit and 12th week visit.

Group Type: ACTIVE_COMPARATOR

Vyvanse

Intervention Type: DRUG

30 mg - 70 mg capsules taken every morning for 6 weeks.

fMRI

Intervention Type: PROCEDURE

Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.

Placebo

Intervention Type: DRUG

Placebo capsules taken every morning for 6 weeks.

Placebo

Vyvanse capsule, 30-70 mg, each morning for 6 weeks.

Placebo capsule each morning for 6 weeks.

Brain scans (fMRI) performed at baseline, 6th week visit and 12th week visit.

Group Type: PLACEBO_COMPARATOR

Vyvanse

Intervention Type: DRUG

30 mg - 70 mg capsules taken every morning for 6 weeks.

fMRI

Intervention Type: PROCEDURE

Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.

Placebo

Intervention Type: DRUG

Placebo capsules taken every morning for 6 weeks.

Interventions

Vyvanse

30 mg - 70 mg capsules taken every morning for 6 weeks.

Intervention Type: DRUG

fMRI

Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.

Intervention Type: PROCEDURE

Placebo

Placebo capsules taken every morning for 6 weeks.

Intervention Type: DRUG

Other Intervention Names

functional magnetic resonance imaging

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Michael G. Tramontana

Associate Professor of Psychiatry, Neurology, and Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael G Tramontana, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

TBI 090563

Identifier Type: -

Identifier Source: org_study_id