Clinical Trials for Brain Trauma

In 2000, the National Institute of Neurological Disorders and Strokes sponsored a workshop for experts to review results of recent traumatic brain injury clinical trials and to apply the lessons learned to new and improved clinical trials.

Large number of TBI patients die and many survive with severe, long-term disabilities.

Traumatic brain injury (TBI) is a complex disease, with a variety of precipitating causes that affect the location and severity of injury and influence the course of recovery.

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During the workshop discussion, results of recent clinical trials in TBI were reviewed by the participants, and several common themes and problems were highlighted. Among the most prevalent concerns were: What are the most relevant mechanisms of injury to test? What are the best ways to translate results from animal models to clinical testing? What are the appropriate patient populations in which to test these mechanisms? What the right outcome measures to use?

For a variety of reasons, no clinical trial in head injury has been effective. Several trials were terminated early, due to mortality in drug-treated groups or to disruption of study drug supply. Also, the management of head injuries in the intensive care unit has a large impact on outcome and must be considered when assessing any experimental intervention.

The goal of the workshop was to design better brain trauma clinical trials, using lessons learned from previous trials. Recommendations for future trials include: Tailoring the protocol to be relevant to the human head injury; obtaining pre-clinic data for new drugs; focus the trial on the right population subgroup; choose correct outcome measurement perhaps consider mild to moderate TBI vs. severe TBI; confirm timely drug intervention; and establish procedures for informed consent because of a critical window of opportunity to do so.

At any time there are dozens of head trauma clinical trials in motion – recruiting, active, or completed. Recently completed was a clinical trial on the effects of aerobic exercise on moods after traumatic brain injury. The clinical trial was sponsored by the University of Washington.

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An active (no longer recruiting) clinical trial for TBI is mood related with drug intervention and how effective is telephone counseling to manage behavior. Some of the clinical trials involve children.

Before opting for a brain trauma clinical trial for yourself or a family member, be sure to understand the restrictions and the liabilities.

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