Detection of traumatic brain injury
Inventors
Patel, Sarjubhai • Rau, Thomas
Assignees
University of Montana Missoula
Publication Number
US-10815529-B2
Publication Date
2020-10-27
Expiration Date
2035-03-26
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Abstract
The present invention provides minimally invasive methods of detecting, diagnosing, and assessing neuronal damage associated with traumatic brain injury (TBI) or chronic traumatic encephalopathy (CTE). Specific species of microRNAs (miRNA), small, noncoding RNA molecules that play gene regulatory functions, are correlated with cellular damage and oxidative stress following TBI or CTE, allowing for rapid, minimally-invasive diagnosis and assessment of brain injury. The early identification and longitudinal assessment of neuronal damage in subjects suffering from or at risk of suffering from a TBI (e.g., football players, boxers, military personnel, fall victims) will improve clinical outcomes by guiding critical medical and behavioral decision making.
Core Innovation
The invention provides minimally invasive methods and kits for detecting, diagnosing, and assessing neuronal damage associated with traumatic brain injury (TBI) or chronic traumatic encephalopathy (CTE) by quantifying specific species of microRNAs (miRNA) that are correlated with cellular damage and oxidative stress. These methods enable rapid diagnosis and ongoing assessment of brain injury via biological samples such as blood, plasma, serum, cerebral spinal fluid, or brain tissue by comparing the expression of identified miRNAs to control levels from healthy subjects. A difference in expression of 1.2 fold or greater between patient and control microRNA levels is indicative of brain injury.
The invention addresses the need for non-invasive diagnostic tools to evaluate TBI-induced neuronal damage or monitor CTE progression, as current methodologies are inadequate for detecting biochemical changes in the brain or cellular dysfunction following mild TBI. Existing methods cannot provide early or longitudinal assessments necessary for timely clinical decision-making to prevent further brain damage at a cellular level.
The core innovation encompasses the use of miR-specific oligonucleotide probes (with at least 70% complementarity to SEQ ID NOs. 1-69 or specified SEQ ID NOs) to measure expression levels of miRNA associated with brain injury. This measurement can guide not only diagnosis but also subsequent treatment, such as administering antioxidants if brain injury is detected. The approach allows for both initial assessment and longitudinal tracking of injury progression or recovery.
Claims Coverage
There is one independent claim that defines the main inventive features related to a kit for detecting traumatic brain injury.
Kit using miR-specific oligonucleotide probes to detect traumatic brain injury
The inventive feature is a kit that includes: - One or more miR-specific oligonucleotide probes having at least 70% complementarity to sequences selected from SEQ ID NOs. 5, 30, 41, and 54. - One or more control samples. - Instructions containing steps for: 1. Contacting a biological sample derived from a patient with at least one miR-specific oligodeoxynucleotide probe targeting SEQ ID NOs. 5, 30, 41, and 54. 2. Measuring the expression level of at least one microRNA represented by the selected SEQ ID NOs by quantifying the probe in the patient biological sample. 3. Obtaining or performing a measurement of a control expression level of the corresponding microRNA in a control biological sample derived from a healthy subject or tissue. 4. Measuring a 1.2 fold or greater increase in the expression level in the patient compared to the control, to determine that the patient has suffered a traumatic brain injury. 5. Treating the traumatic brain injury in the patient determined to have suffered a traumatic brain injury.
The claim covers a kit that enables minimally invasive, quantitative detection of specific miRNAs in patient samples to diagnose traumatic brain injury, with instructions for measurement and recommended treatment steps.
Stated Advantages
Provides a minimally invasive, rapid method for detecting and diagnosing brain injury using biological samples such as blood or plasma.
Allows for early identification and longitudinal assessment of neuronal damage to guide clinical and behavioral decision making.
Enables monitoring of injury progression or healing through repeated measurement and comparison of miRNA expression levels.
Reduces reliance on post-mortem diagnosis and enhances the ability to detect molecular and cellular damage not visible by traditional methodologies.
Documented Applications
Detection, diagnosis, and assessment of traumatic brain injury (TBI) or chronic traumatic encephalopathy (CTE) in humans.
Early identification and monitoring of subjects at risk of TBI, such as athletes (football players, boxers), military personnel, and fall victims.
Longitudinal tracking of neuronal damage progression or healing in subjects suffering from or at risk for TBI.
Medical imaging and diagnosis of TBI, CTE, and related conditions in humans and animals, including domesticated, companion, exotic, farm, and research animals.
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