SPARK BIOMEDICAL INC. — Department of Defense STTR Phase I: A21C-T024

Description

Acute stress reaction (ASR) is a risk factor for completed suicide and can lead to having post-traumatic stress disorder (PTSD) symptoms. Patients with PTSD have shown a greater propensity to alcohol and opioid abuse. ASR typically lasts much less than 48 hours, so a rapidly deployable approach is needed to immediately treat ASR to avert long-lasting adverse effects. Current military ASR treatment efforts involve front-line psychiatry and combat operational stress control. The success of these treatments depends on proximity to care and immediacy of the applied therapy. Trained personnel are required to quickly administer the treatment. Many battlefield situations do not allow for the affected soldier to be close enough to trained personnel to avert adverse effects from an ASR event. Data suggests vagus nerve stimulation (VNS) can attenuate stress-related symptoms such as anxiety, hyperarousal, and social avoidance. Spark Biomedical recently attained 510(k) clearance for the Sparrow device, a wearable device that fits around the ear and transcutaneously stimulates the auricular branch of the vagus nerve. Under this STTR effort, the Spark team will integrate control electronics into an earpiece that will withstand extreme environments and be worn under a military helmet to be optimized for far-forward, military battlefield use.