Development and Testing of a Military-Grade Wearable Transcutaneous Auricular Neurostimulation Device to Restore Performance after Acute Stress Reaction

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 or prevent 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. In Phase I, the Spark team developed the performance parameters and form factor of a disposable, cable-free wearable transcutaneous auricular neurostimulation device to treat or prevent ASR in far-forward battlefield environments. In the proposed Phase II work, Spark will develop a clinical grade tAN device and test its efficacy to restore performance on operationally relevant tasks in a clinical model of laboratory stress. ĀA pre-submission application will be submitted to the FDA to get feedback on the regulatory strategy and the future clinical study design.