Saturday, March 21, 2015

Six Top Clinical Trials in Traumatic Brain Injury (TBI)

Bill Yates
Brain Posts
10th July 2014

This month topic is traumatic brain injury (TBI). I have reviewed some recent research manuscript related to the epidemiology and brain imaging issues of TBI.

Today I am posting links to clinical trials recently completed in the treatment of TBI.

I was surprised at the low number of high-quality clinical trials in TBI.

Given the public health burden of TBI, more rigorous randomized controlled trial efforts need to funded.

After reviewing about 100 PubMed abstracts, these five stand out to me as important additions to our knowledge base. Clicking on the heading will take you to the full abstract.

Hyperbaric oxygen therapy following blast-related traumatic brain injury in veterans
U.S. Navy veterans with blast-related TBI and post concussion syndrome were randomized to receive a trial of 40 sixty minute treatments with hyperbaric oxygen therapy. There was no evidence of improvement over three months with hyperbaric oxygen in this cohort.

A phase II interleukin receptor-1 antagonism randomized controlled trial in humans 
Rodent models of traumatic brain injury suggest the potential for several types of neuroprotective drugs to potential reduce the neuronal damage with TBI. In this phase II study ten humans received a interleukin-1 antagonist designed to reduce inflammatory response. The trial found the treatment safe with an improved brain extracellular fluid profile. The authors note this study supports potential phase III effectiveness trials for this treatment.

A trial of zolpidem for sustained coma (disturbance of consciousness)
Case reports have been published of remarkable if brief restoration of consciousness in those with coma or other consciousness impairment. In this randomized, controlled single dose study of zolpidem 4 out of 84 subjects had a definite consciousness improvement with active drug. This sample included both TBI and non-TBI subjects and suggests the potential for further study of zolpidem and other agents in this class for consciousness modification in TBI.

Blood transfusion in children with TBI
This study is not technically a clinical trial but a retrospective chart review. Paradoxically, children receiving blood transfusion following TBI showed worse outcomes than those who did not receive a transfusion. However, children with hemoglobin less than 8 g/dl did appear to benefit from transfusion.

Comparison of brain surgery (decompressive craniectomy) versus medical manage in TBI patients with elevated intra-cranial pressure
Maintaining normal intracranial pressure is a key goal in treatment of TBI. In this clinical trial, 373 subjects received either brain surgery or medical management of hypertension. There was no survival benefit to early neurosurgical intervention and the authors note the cost of this intervention is significant.

Adding acupuncture to standard TBI in a cohort of Chinese earthquake victims:
In a study of 73 adult subjects, acupuncture-augmentation treated subjects showed superior outcome over standard Western treatment alone in cognitive function and activities of daily living.

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