Digital Biomarkers and Remote Testing for Neurogenic Thoracic Outlet Syndrome

About This Grant

ABSTRACT Neurogenic thoracic outlet syndrome (NTOS) is a prevalent disorder of dynamic compression of the brachial plexus between the first rib and scalene muscles of the neck. It results in pain, paresthesias, and functional impairment of the upper extremity. The two greatest challenges in the field are diagnostic uncertainty and a lack of objective metrics to impartially evaluate response to surgical and medical therapy. The symptoms of NTOS overlap with other conditions and its diagnosis is based on subjective clinical assessment by highly specialized providers. There is no diagnostic test or means to conveniently screen for NTOS, and this results in delayed diagnosis, prolonged suffering, and extensive unnecessary workup. Additionally, the absence of measures to objectively monitor therapeutic outcomes has limited confidence in the efficacy and expectations of existing treatments and deterred rigorous evaluation of new therapies. We address these challenges with a platform that assesses upper extremity function with novel digital biomarkers of motor capacity that are directly impacted by NTOS. We have developed the “Press Test” as a 20-second hand-over-head task that provokes NTOS pathophysiology, during which we extract upper extremity motor function data from a wearable sensor. In this project, we test a novel AI-powered remote patient monitoring (RPM) system that extracts identical data from standard telemedicine webcam video (without sensors) to identify and monitor NTOS-related motor dysfunction. Our objective is to enhance the care of NTOS patients by enabling a remote, scalable, and cost-effective method to accelerate diagnosis and referral to expert providers, and to provide a convenient platform for short- and long- term objective monitoring of surgical and medical therapy. In Aim 1, we will identify digital biomarkers that are specific for NTOS disability in a prospective cohort study. Participants are patients diagnosed with NTOS at our expert center and patients referred for NTOS that we diagnose with other conditions. We hypothesize that the RPM platform can identify the impairments of upper extremity function that are directly impacted by NTOS and achieve comparable accuracy to the wearable system. In Aim 2, we will conduct a prospective observational clinical trial to determine the ability of the RPM solution to monitor objective changes in functional disability following NTOS therapy. For 12 months, we will monitor 50 NTOS patients undergoing physical therapy and 50 NTOS patients undergoing surgery with digital biomarkers of extremity function and patient-reported outcome (PRO) questionnaires. We hypothesize that video-based RPM digital biomarkers will effectively track therapeutic responses and provide greater sensitivity to change compared with conventional PROs. We will explore whether pre-treatment digital biomarkers can predict responses to therapy, supporting personalized management strategies. This project is expected to reduce diagnostic uncertainty, facilitate timely referrals to specialty providers, provide a complementary understanding of functional and patient-reported disability, enhance patient engagement and access to personalized care, and create a foundation for rigorous clinical trials of novel therapy.