UH3NS135168

IMPACT: INTEGRATIVE MINDFULNESS-BASED PREDICTIVE APPROACH FOR CHRONIC LOW BACK PAIN TREATMENT - IMPACT ABSTRACT CHRONIC PAIN IMPACTS 50 MILLION U.S. ADULTS, SEVERELY INTERFERES WITH THE WORK AND LIFE OF OVER 25 MILLION, AND COSTS $635 BILLION ANNUALLY FOR MEDICAL TREATMENT AND RESULTANT LOSS OF PRODUCTIVITY. WHILE SOME NON- PHARMACOLOGICAL COMPLEMENTARY PAIN MANAGEMENT METHODS, SUCH AS MINDFULNESS-BASED STRESS REDUCTION (MBSR), ARE EFFECTIVE AT REDUCING THE PAIN OF SOME PATIENTS, OTHERS DO NOT RESPOND. CLINICIANS LACK THE TOOLS TO ACCURATELY AND RELIABLY PREDICT WHICH PATIENTS WILL RESPOND TO COMPLEMENTARY TREATMENTS. IN RESPONSE TO RFA-NS-22-050 (UG3/UH3), IMPACT – INTEGRATIVE MINDFULNESS-BASED PREDICTIVE APPROACH FOR CHRONIC LOW BACK PAIN TREATMENT PROPOSES USING MACHINE LEARNING METHODS (A SUBFIELD OF AI) TO IDENTIFY BIOPSYCHOSOCIAL PREDICTIVE AND MONITORING MARKERS OF THE RESPONSE TO MBSR FOR CHRONIC LOW BACK PAIN (CLBP). THIS RESEARCH WILL INCLUDE A POPULATION (TOTAL N=350) SUFFERING FROM CLBP. COMPREHENSIVE BIOPSYCHOSOCIAL DATA (LOCOMOTOR ACTIVITY, SLEEP, CIRCADIAN RHYTHMS, HEART RATE VARIABILITY, DEPRESSION, ANXIETY, PAIN OUTCOMES, AND SOCIAL SUPPORT) WILL BE COLLECTED FROM PATIENTS TREATED WITH MBSR FOR CLBP. AIM 1 (UG3) WILL INVOLVE THE INITIATION OF A CLINICAL TRIAL OF MBSR FOR CLBP (N=50) AND ML MODELING WITH LONGITUDINAL BIOPSYCHOSOCIAL DATA AND RELATED CLINICAL TRIAL DATASETS TO IDENTIFY CANDIDATE PREDICTIVE AND MONITORING MARKERS OF THE RESPONSE TO MBSR FOR CLBP PRIOR TO EXPANDING THE TRIAL IN THE UH3 PHASE. MILESTONES FOR TRANSITION FROM THE UG3 PHASE (AIM 1) TO THE PENDING CLINICAL TRIAL OF THE UH3 PHASE (AIMS 2+3) WILL INCLUDE: (1) FINALIZED DATA COLLECTION AND PRIMARY ANALYSIS PROTOCOLS FOR THE CLINICAL TRIAL OF MBSR FOR CLBP, (2) SUCCESS WITH PASSIVE DATA COLLECTION PROCEDURES AND EXPERIMENTATION WITH ML MODEL TRAINING AND TESTING FOR THE IDENTIFICATION OF PREDICTIVE AND MONITORING BIOPSYCHOSOCIAL MARKERS OF THE RESPONSE TO MBSR FOR CLBP, AND (3) PRELIMINARY VALIDATION OF CANDIDATE ML-BASED BIOPSYCHOSOCIAL PREDICTIVE AND MONITORING MARKERS OF THE RESPONSE TO MBSR FOR CLBP USING STATISTICAL AND CROSS-VALIDATION METHODS. AIM 2 (UH3) WILL EXPAND THE CLINICAL TRIAL INITIATED IN AIM 1 TO COLLECT BIOPSYCHOSOCIAL DATA FROM A SAMPLE OF 300 INDIVIDUALS. AIM 3 (UH3) WILL INVOLVE ML MODELING WITH DATA COLLECTED IN AIM 2 TO IDENTIFY AND VALIDATE ACCURATE BIOPSYCHOSOCIAL PREDICTIVE AND MONITORING MARKERS OF THE RESPONSE TO MBSR FOR CLBP. TO COMPLETE OUR AIMS, CLINICIAN SCIENTISTS FROM BOSTON UNIVERSITY, UNIVERSITY OF MASSACHUSETTS CHAN MEDICAL SCHOOL, AND CAMBRIDGE HEALTH ALLIANCE WITH EXTENSIVE EXPERTISE IN SUCCESSFULLY RECRUITING AND ENGAGING POPULATIONS IN CLINICAL TRIALS OF MINDFULNESS INTERVENTIONS FOR PAIN WILL COLLABORATE WITH BIOMEDICAL, DATA SCIENTISTS AND MACHINE LEARNING RESEARCHERS FROM WORCESTER POLYTECHNIC INSTITUTE. THIS PROPOSED PROJECT WILL ULTIMATELY ENHANCE CLINICAL DECISION- MAKING AND TARGETED TREATMENT OF CLBP.

Worcester Polytechnic Institute

TO SUPPORT BASIC AND CLINICAL NEUROSCIENCE, BIOMEDICAL, BEHAVIORAL AND SOCIAL SCIENCE, EPIDEMIOLOGIC, HEALTH SERVICES AND HEALTH DISPARITY RESEARCH. TO DEVELOP NEW KNOWLEDGE AND APPROACHES RELATED TO THE PREVENTION, DIAGNOSIS, TREATMENT, ETIOLOGY, AND CONSEQUENCES OF DRUG ABUSE AND ADDICTION, INCLUDING HIV/AIDS. TO SUPPORT RESEARCH TRAINING AND RESEARCH SCIENTIST DEVELOPMENT. TO SUPPORT DISSEMINATION OF RESEARCH FINDINGS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) LEGISLATION IS INTENDED TO EXPAND AND IMPROVE THE SBIR PROGRAMS TO EMPHASIZE AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF TECHNOLOGY DEVELOPED THROUGH FEDERAL SBIR RESEARCH AND DEVELOPMENT, INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN THE SBIR PROGRAM. THE LEGISLATION INTENDS THAT THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.279 - Drug Abuse and Addiction Research Programs

National Institute of Neurological Disorders and Stroke (NNDS) [HHS - NIH]

Massachusetts United States

State-Wide

HEAL Initiative: Discovery of Biomarkers and Biomarker Signatures to Facilitate Clinical Trials for Pain Therapeutics (UG3/UH3 Clinical Trial Optional) (RFA-NS-22-050)