NEUROTYPE INC. — Department of Health and Human Services SBIR Phase I: NIDA

Description

Project Summary / Abstract Significance: In 2021, more than 75,000 people in the United States died from opioid overdoses. Clinics that treat Opioid Use Disorder (OUD) lack Food and Drug Administration (FDA)-regulated devices that can be prescribed to alleviate cravings and prevent drug use and overdoses. The objective of this SBIR Phase I project is to develop and test a portable neurotherapeutic device that reduces drug craving processes using brain training. Innovation: Craving and drug use following OUD treatment are precipitated by patients’ “attention bias” towards people, places, and things associated with prior drug use. For example, encountering a pill bottle may evoke intensified attention towards additional drug-related cues, leading to physiological craving and drug-seeking behavior. Attention Bias Modification (ABM) is a therapeutic approach that trains patients’ attention away from triggers for drug use (e.g., pill bottle) and towards natural, non-drug-related scenarios (e.g., prosocial cues), curtailing drug use and overdose. Neurotype Inc. will develop Modit-AB™, a neurotherapeutic device that uses closed-loop neurofeedback and mobile electroencephalogram (EEG) headsets to modify drug-related attention biases in OUD. Specific aim 1: in 15 healthy controls and 15 abstinent OUD inpatients, we will evaluate the technical feasibility of 3 types of ABM integrated with real-time neurofeedback using the Modit-AB™ prototype. Here, the effects of ABM neurofeedback on neurobehavioral measures of attention and attention bias will be evaluated. Specific aim 2: we will assess the expectations, perceptions, and user criques of Modit-AB™ using a “Future Workshop” co-designing approach with clinicians (n = 10) and patients (n = 20) from participating OUD treatment programs. Clinician and patient feedback will guide device design. Expected outcomes: the technical and commercial feasibility of Modit-AB™ will be determined by its ability to successfully modify drug-related attention biases and craving processes in patients with OUD at the point of care (e.g., clinic office, waiting room). Finally, we will conduct a pre-submission meeting with the FDA to clarify Modit-AB™’s regulatory pathway and plan for the SBIR Phase II project. Investigators: Neurotype Inc. and its team of collaborators includes experts in clinical neuroscience, addiction medicine, EEG brain monitoring, product development, software engineering, healthcare, and regulatory matters.