Traumatic Brain Injury Clinical Trial
Official title:
The Effect of OMT on Functional Outcomes and Anti-inflammatory Biomarkers in Mild to Moderate Traumatic Brain Injury
Test the hypothesis that a certain set of osteopathic manipulation procedures preformed on patients with mild to moderate traumatic brain injury will result in accelerated rates of recovery assessed using vestibular function tests, quality of life questionnaires and measurements of the levels of anti-inflammatory metabolite and protein biomarkers in the blood and urine.
This project proposes to test the hypothesis that a certain set of osteopathic manipulative
treatment (OMT) procedures performed on patients with mild to moderate traumatic brain injury
(TBI) will result in accelerated rates of recovery as assessed using vestibular function
tests, patient response on quality of life questionnaires, and measurements of the levels of
anti-inflammatory metabolite and protein biomarkers in urine and blood. The OMT techniques,
performed ensemble (as a set) and in sequence, will encompass: (a) soft tissue to the
upper-mid thoracic spine; (b) soft tissue to the cervical spine; (c) suboccipital release;
(d) condylar decompression; and (e) cranial venous sinus release. The key clinical outcome
measures will include Neurocom Balance Manager assessments (Modified Clinical Test of Sensory
Interaction and Balance; Stability Evaluation Test; Rhythmic Weight Shift; Limits of
Stability), Vestibular Oculomotor Screen, Motion Sensitivity Test, as well as questionnaires
such as Headache Impact Test (HIT-6), Dizziness Handicap Inventory, and the more general
quality of life measures (dressing, bathing, medication management, etc. as assessed by the
SF 36 QOL questionnaire).
A unique and trail blazing aspect of our proposed work is to screen for biochemical
alterations in the plasma and urine of these patients following administration of OMT and to
correlate these changes with vestibular function tests and other clinical parameters that may
shed light on the biological mechanism(s) underlying the OMT. The impact of our proposed
research lies in our attempt to establish a foundation for the basis of using OMT procedures
to accelerate recovery of patients following mild to moderate brain injury and to find
correlations between cognitive functions, biochemical markers, and self-reported assessments
of quality of life.
The successful achievement of positive outcomes in this project will serve as the basis for
our future efforts to seek funding from the National Institutes of Health for recruitment of
larger numbers of subjects in a multi-center research effort.
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