Spark Wins $3.5M DoD Grant to Build Neurostim Device for Battlefield Stress

Spark Biomedical, a Dallas-based wearable neurostimulation technology company, was awarded a $1.15 million Phase II grant to develop its Sparrow Hawk transcutaneous auricular neurostimulation (tAN) device to treat adverse effects of acute stress reaction (ASR).
 
The company is partnering with Battelle Memorial Insitute for a rapidly deployable, non-invasive, wearable solution for preventing and treating ASR in the battlefield setting. ASR can cause anxiety, nausea, irritability, dysregulated emotions, poor sleep, poor concentration, cognitive fatigue, and headaches. According to the Armed Forces Health Surveillance Branch, mental health issues bring about more military medical evaluations than any other condition.
 
An International Journal of Epidemiology study has also linked ASR to a 10-fold increase in completed suicide risk, and can lead to developing post-traumatic stress disorder (PTSD) symptoms, often causing substance abuse issues. Current military ASR treatment efforts mainly consist of frontline psychiatry and combat operational stress control. However, battlefield scenarios can limit access to immediate care.
 
“We are deeply committed to exploring the positive impact of tAN therapy on alleviating acute stress reaction and the potential long-term effects related to PTSD. Our wearable technology has the capacity to provide timely and non-invasive neurostimulation, making it a game-changer for various neuropsychiatric conditions. Particularly, in supporting the brave men and women serving our country, this device could be invaluable in military far-forward environments, and civilian use for patients experiencing ASR in the emergency department,” Dr. Navid Khodaparast, study co-principal investigator, and chief science officer of Spark Biomedical, told the press.
 
In Phase I, Spark developed performance parameters and form factors for its compact, disposable, care-free, “all-in-one” wearable tAN device.
 
In Phase II, Spark and Battelle plan to develop a functioning Sparrow Hawk tAN device that can be used in a clinical trial. It will be tested in a clinical setting to evaluate efficacy in restoring performance on operationally relevant tasks in a “meticulously crafted” clinical model of laboratory stress.
 
Spark says Sparrow Hawk was designed to comfortably fit under a military helmet, making it suitable for far-forward environments where immediate care access could be limited. The company also believes it can benefit Frontline health workers, firefighters, police officers, and first responders to reduce stress-related neurological events. Patients seeking care in a hospital because of experiencing or witness a traumatic event may also benefit.
 
“Spark is proud to continue our partnership with the team at Battelle to conduct the first randomized controlled clinical trial assessing the use of tAN therapy to treat and prevent symptoms of acute stress reaction. Once healthy participant recruitment begins, participants will be randomized to receive active or sham tAN therapy either prior to or during the acute stressor while undertaking tasks relevant to military operational environments. The results of this trial will be critical to optimizing the use of this therapy and lay the groundwork for future trials in real-world settings.” Dr. Melanie McWade, co-principal investigator, and senior director of clinical operations at Spark.