BrainGain: a neurofeedback platform to improve memory from home in individuals with schizophrenia

About This Grant

Abstract Schizophrenia is a devastating mental disorder with enormous personal disability and societal cost. Cognitive impairment, especially working memory (WM), is a core symptom driving disability, so cognitive rehabilitation treatments are desperately needed to improve functioning in individuals with schizophrenia. In the past decade, neuromodulation of gamma frequency brain rhythms has emerged as a promising new treatment target to improve cognition. Cognitive impairment, especially WM, has been associated with deficient frontal cortex gamma activity and a number of promising gamma neuromodulation treatments suggest enhancing gamma can enhance memory in schizophrenia. Thus, increasing frontal gamma may improve WM. Electroencephalographic neurofeedback (EEG-NFB) is a promising treatment that can guide an individual to enhance frontal gamma waves by providing positive feedback via visual and auditory cues typically in a game (e.g., racing a car). Our prior NIMH-funded research has shown that gamma-NFB can improve frontal gamma and WM memory in individuals with schizophrenia in our university lab setting. In this Phase I project, our company, BioSignal Solutions, will translate this promising approach out of the lab to a mobile platform (BrainGain® app with wireless EEG headband), so individuals with schizophrenia can enhance their memory circuits at home or in a community clinic setting. Using an iterative, user-centered co-design process (e.g., hands on usability workshops with patients, caregivers and healthcare staff), we will convert headsets currently used in our in-lab clinical trials into simplified versions for patients to use at home. We will validate the mobile BrainGain® platform through equivalency testing with our in-lab UC San Diego gamma-NFB protocol to demonstrate reliable and accurate signal acquisition and preprocessing and key gamma-NFB training metrics (gamma coherence and dynamic reinforcement thresholds). We will then conduct a preliminary randomized controlled trial (RCT) to test the feasibility and efficacy of BrainGain when self-administered by individuals with schizophrenia at home. Product development will also include working with expert consultants with commercial medical device and FDA-approval experience. After this Phase I device development project and estimating effect sizes in the preliminary RCT, we will finalize design and production of the product for FDA-compliant Phase II clinical testing in a larger confirmatory RCT. Ultimately, we aim to deliver safe, effective and accessible mobile gamma-NFB treatment to improve memory and functioning in millions of Americans living with schizophrenia. 1