Recruiting

Pharmacological Treatment

Sponsor:

Kessler Foundation

Code:

NCT00489892

Conditions

Traumatic Brain Injury

Severe Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Modafinil

Study Details

Brief summary:

This study is designed to examine the effects of a wake-promoting agent (Modafinil) on working memory (WM) in persons with moderate to severe TBI utilizing a double blinded placebo controlled methodology. Our approach is to evaluate participants with BOLD fMRI and a limited neuropsychological battery to examine WM performance before and after pharmacological intervention.

Hypotheses

1. Because increased cognitive effort (as a function of decreased efficiency after TBI) is presumed to underlie fMRI activation dispersion that is seen during central executive WM tasks, we anticipate an attenuation of cerebral activation in prefrontal cortex during pharmacological intervention with Modafinil when compared to placebo administration on the mPASAT and vigilance testing.
2. There will be a correlation between the decreased dispersion of the fMRI signal on scans and improvement in neuropsychological measures when individuals are on Modafinil that is not seen when they are taking placebo.

Conditions

Traumatic Brain Injury

Severe Traumatic Brain Injury

Study ID

NCT00489892

Start date

Aug, 2003

Status verified date

Jul, 2007

Completion date

Dec, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

We will include only those subjects who have sustained moderate to severe initial injuries, as defined by an initial 24-hour Glasgow Coma Scale 128 scores below 13. In the event that a GCS score is not available, subjects will only be included if there is sufficient medical documentation that would allow for a post-hoc estimation of initial GCS, or if other confirmatory data (e.g., positive anatomic neuroimaging findings, focal neurologic signs) are available. Individuals with a history of prior moderate to severe head injury, stroke, seizures, severe psychiatric disturbances (i.e., those known to influence memory performance, such as schizophrenia, bipolar disorder), or drug abuse will not be included as subjects. In addition, a score of 11 or greater on the Mini Mental Status Exam will be required to insure that subject can participate effectively in the study protocol. Because of potential effects on cognition and hemodynamic response, subjects currently taking benzodiazepines, narcotics, neuroleptics, anticonvulsants, antispasticity agents or psychostimulants will not be included.

In addition, any patient that is on medications that may interact with any of the study medications (e.g. birth control bills or cyclosporin). Psychiatric symptoms and substance abuse history will be obtained using a structured psychiatric interview, the Diagnostic Interview Schedule 129DIS. In addition patients with history of drug dependency, hypertension out of control, significant cardiac disease, or inability to undergo MRI. (e.g. metalworker, Medtronic infusion pump)

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Modafinil

Primary outcome measure

  • mPASAT [ Time Frame: Pre-Treatment, Post-Treatment ]
  • Dispersion of fMRI signal [ Time Frame: Pre-Treatment, Post-Treatment ]
  • Simple Vigilance Task [ Time Frame: Pre-Treatment, Post-Treatment ]
  • Neuropsychological Battery (Digit Vigilance Task, California Verbal Learning Test, Digit Span and Continuous Performance Task) [ Time Frame: Pre-Treatment, Post-Treatment ]

Central Contacts and Locations

Central contacts

Locations

Kessler Medical Rehabilitation Research & Education Corporation

Recruiting

West Orange, New Jersey, United States, 07052

Principal Investigator:

Elie P Elovic, M.D.

More Information

Sponsor

Kessler Foundation

Last update posted

Jul 25, 2007

Last verified

Jul, 2007

Keywords

  • traumatic brain injury
  • TBI
  • working memory
  • modafinil
  • fMRI
  • MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2007-07-25.