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

Traumatic Brain Injury Clinical Trial

Official title:

Psychostimulant Treatment of TBI-Related Attention Deficits: fMRI Analysis of Neural Mechanisms of Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01000064
• Other study ID #: TBI 090563
• Status: Completed
• Phase: Phase 3
• First received: October 15, 2009
• Last updated: June 3, 2015
• Start date: October 2009
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder
• Attention Deficit Disorder with Hyperactivity
• Brain Injuries
• Traumatic Brain Injury

Intervention

Drug:
• Vyvanse
30 mg - 70 mg capsules taken every morning for 6 weeks

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

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of various components of attention, related cognitive processes, ADHD symptoms, emotional status, and quality of life ratings using various tests and scales such as Word List learning, ADHD Rating Scale, Beck Depression Inventory, etc.		12 weeks	No
Secondary	Evaluation of which types of patients are most likely to benefit from treatment.		12 weeks	No
Secondary	The study will utilize fMRI methods, as well as neurobehavioral measures, to elucidate neural mechanisms of response.		12 weeks	No