U44NS122002

Actigraphy Enhanced Clinical Chronic Lower Back Pain Management - Abstract

Effective management of patients with chronic low back pain requires accurate and reliable methods to measure the effects of treatment on both pain and function. Yet, this presents a serious dilemma to clinicians, who must currently rely exclusively on retrospective self-report measures (e.g., questionnaires) to capture this information.

These assessments are usually only completed each time the patient returns to the clinic, thus placing an over-reliance on patients' memories and potentially missing critical inflection points in symptom or functional trajectories. The combination of potentially biased and unreliable reporting makes this method of assessment far from optimal.

We recently completed the NIH I-Corps program that revealed pain specialists are in urgent need of objective data on patient functioning to guide treatment decisions. The physicians we interviewed indicated that quantitative assessment of activity levels, or actigraphy, may provide a solution because it is a validated clinical research tool for assessing pain-related disability/function and response to treatment.

The hurdles faced by existing commercial and research devices, however, have prevented the implementation of actigraphy for routine clinical care due to the technological burden for patients and clinicians (e.g., device charging, Bluetooth/Wi-Fi pairing, required apps, syncing, analysis software), cost, and the lack of standardization in device quality and data output.

Therefore, we propose to commercialize a new class of clinical-grade wearable activity monitor, called the Vera Band, designed specially to be integrated into healthcare workflows. The Vera Band will provide a low-profile, durable, ultra-low-cost wearable and supporting service that presents no technical burden to patients or clinicians and can collect accurate daily activity data.

Phase I of this fast-track application will consist of both aims 1 and 2, each 1-year in duration. We will first conduct an iterative technical design and laboratory verification process, along with establishing the required technical and regulatory infrastructure to provide the proposed service (Aim 1). We will then assess its usability and workflow integration and verify its technical equivalence against a leading FDA-approved actigraphy monitor used in clinical research (Aim 2). By the conclusion of Aim 2, we propose to obtain FDA 510(k) clearance.

During Phase II, we will conduct a multi-center clinical study, across four tertiary pain clinics, over a period of 3 years to determine physician satisfaction with device usability and likelihood of clinical adoption (Aim 3).

Arbor Medical Innovations

(1) TO SUPPORT EXTRAMURAL RESEARCH FUNDED BY THE NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) INCLUDING: BASIC RESEARCH THAT EXPLORES THE FUNDAMENTAL STRUCTURE AND FUNCTION OF THE BRAIN AND THE NERVOUS SYSTEM, RESEARCH TO UNDERSTAND THE CAUSES AND ORIGINS OF PATHOLOGICAL CONDITIONS OF THE NERVOUS SYSTEM WITH THE GOAL OF PREVENTING THESE DISORDERS, RESEARCH ON THE NATURAL COURSE OF NEUROLOGICAL DISORDERS, IMPROVED METHODS OF DISEASE PREVENTION, NEW METHODS OF DIAGNOSIS AND TREATMENT, DRUG DEVELOPMENT, DEVELOPMENT OF NEURAL DEVICES, CLINICAL TRIALS, AND RESEARCH TRAINING IN BASIC, TRANSLATIONAL AND CLINICAL NEUROSCIENCE. THE INSTITUTE IS THE LARGEST FUNDER OF BASIC NEUROSCIENCE IN THE US AND SUPPORTS RESEARCH ON TOPICS INCLUDING BUT NOT LIMITED TO: DEVELOPMENT OF THE NERVOUS SYSTEM, INCLUDING NEUROGENESIS AND PROGENITOR CELL BIOLOGY, SIGNAL TRANSDUCTION IN DEVELOPMENT AND PLASTICITY, AND PROGRAMMED CELL DEATH, SYNAPSE FORMATION, FUNCTION, AND PLASTICITY, LEARNING AND MEMORY, CHANNELS, TRANSPORTERS, AND PUMPS, CIRCUIT FORMATION AND MODULATION, BEHAVIORAL AND COGNITIVE NEUROSCIENCE, SENSORIMOTOR LEARNING, INTEGRATION AND EXECUTIVE FUNCTION, NEUROENDOCRINE SYSTEMS, SLEEP AND CIRCADIAN RHYTHMS, AND SENSORY AND MOTOR SYSTEMS. IN ADDITION, THE INSTITUTE SUPPORTS BASIC, TRANSLATIONAL AND CLINICAL STUDIES ON A NUMBER OF DISORDERS OF THE NERVOUS SYSTEM INCLUDING (BUT NOT LIMITED TO): STROKE, TRAUMATIC INJURY TO THE BRAIN, SPINAL CORD AND PERIPHERAL NERVOUS SYSTEM, NEURODEGENERATIVE DISORDERS, MOVEMENT DISORDERS, BRAIN TUMORS, CONVULSIVE DISORDERS, INFECTIOUS DISORDERS OF THE BRAIN AND NERVOUS SYSTEM, IMMUNE DISORDERS OF THE BRAIN AND NERVOUS SYSTEM, INCLUDING MULTIPLE SCLEROSIS, DISORDERS RELATED TO SLEEP, AND PAIN. PROGRAMMATIC AREAS, WHICH ARE PRIMARILY SUPPORTED BY THE DIVISION OF NEUROSCIENCE, ARE ALSO SUPPORTED BY THE DIVISION OF EXTRAMURAL ACTIVITIES, THE DIVISION OF TRANSLATIONAL RESEARCH, THE DIVISION OF CLINICAL RESEARCH, THE OFFICE OF TRAINING AND WORKFORCE DEVELOPMENT, THE OFFICE OF PROGRAMS TO ENHANCE NEUROSCIENCE WORKFORCE DEVELOPMENT, AND THE OFFICE OF INTERNATIONAL ACTIVITIES. (2) TO EXPAND AND IMPROVE THE SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. TO UTILIZE THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM, TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.853 - Extramural Research Programs in the Neurosciences and Neurological Disorders

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

Saline, Michigan 481769175 United States

Single Zip Code

Translational Neural Devices (U44 - Clinical Trial Required) (RFA-NS-18-012)

Amendment Since initial award the End Date has been extended from 08/31/23 to 07/31/27 and the total obligations have increased 378% from $997,078 to $4,765,363.