“The Box”

Diagnostics, especially early diagnostics, of mTBI remains a challenge in spite of its importance for initial triage and further treatment. There is a recognized need in a field deployable device that could be used for fast evaluation of the state of the warfighter and assist in making decision on further action. Recent technical report (2009) prepared by SURVIAC concluded that “the optimal approach to mTBI diagnosis is to provide an inclusive multidisciplinary assessment and adjunctive testing tailored to the context of the patient”.

It is suggested to commit targeted concerted multidisciplinary effort to develop portable field deployable device for the early diagnostic of mTBI. It is envisioned that such highly portable device will collect set of parameters/biomarkers, which will be mathematically processed to produce meaningful integrative score. This score would assist in making decision on the further action related to the warfighter treatment.

The parameters could be of different modalities such as EEG, EOG, EKG, evoked potential, biochemical biomarkers, neurological tests, cognitive tests etc. During the development process the minimum combination of the most informative parameters/tests, which can be recorded/collected in the field conditions, will be selected. Collected data will be submitted for mathematical processing, e.g. principal component analysis, to produce integrative score.

In parallel, processed raw data in condensed form could be transmitted over the narrow information channels, such as cell phone, to be “reconstituted” on the receiving end at the centralized specialized facilities for further analysis and storage. Storage of these data allows reconstruction of initial condition and events occurring immediately after the incident and provides basis for the treatment of warfighter after returning from the theater.

It is conceivable that diagnostic portable device will be akin to “Nintendo DS” handheld gaming console. One screen can provide instructions for the medic, while the second screen could either display collected data or provide test signals for the diagnostics, or questionnaire etc. The device will include set of amplifiers and connectors for the necessary sensors, processor(s) for data processing, memory for data storage and transmitter.

To realize this project four key teams have to be put together. First team will include physiologists, neurologists. This team will be responsible for the parameters selection and collection. Second team will include bioengineers/electronic engineers, who will be responsible for signal collection and initial data processing. Third team will include mathematicians, who will develop most appropriate mathematical data processing for integrative score generation and data reduction. Fourth team will include computer specialists/programmers, who will be developing the appropriate customary software.

The following major development milestones will be implemented. First, initial deep meta analysis (text mining?) of the available experimental and clinical literature related to clinical and laboratory observation on the parameters related to mTBI/concussion will be performed. Identified parameters will be ranked in order of informative value. The most informative parameters will be included in the first iteration of the prototype and the best appropriate mathematical processing will be applied. The integrative score will be validated in the small group of patients. The predicitive/diagnostic power of the first iteration set of parameters will be evaluated. Least informative parameters will be dropped from the set and another parameters can be added along with appropriate changes of the mathematical processing. Several iterations probably will be needed until satisfactory combination of minimal number of parameters and mathematical processing will be achieved in terms of predictive power of the integrative score. Once this task is drafted (or in parallel with it) the bioengineer and computer teams can develop customary designed device.

This diagnostic approach can be scaled up and modified depending on the echelon and services available to include stationary equipment and additional parameters (e.g., imaging). It also will be possible to modify the set of parameters and processing to adapt the technique for monitoring purposes.

In the future, the device can be used as a platform for different field diagnostics besides mTBI. By changing parameters collected and processing software (which can be preprogrammed as a replaceable cartridge for the device) it can be employed for diagnostics and monitoring of other acute conditions, such as circulatory shock.