Anxiety disorders are among the most common mental health conditions worldwide, affecting approximately 264 million people globally. In the UK alone, it is estimated that one in six people will experience a common mental health problem, such as anxiety or depression, in any given week. Anxiety disorders can significantly impair an individual's ability to function in daily life, leading to decreased productivity, strained relationships, and a lower quality of life. The economic burden of anxiety disorders is substantial, with costs related to healthcare, lost productivity, and social welfare support. Given the pervasive nature of anxiety and its profound impact on individuals and society, there is a critical need for innovative treatments. Traditional therapies, such as medication and cognitive-behavioural therapy (CBT), are effective for many but not all individuals. There is a growing demand for alternative and complementary approaches that can provide relief for those who do not respond adequately to existing treatments. MindSpire is an early-stage neurotech company developing bioelectronic headphones for personalised vagus nerve stimulation (VNS) from the outer ear to build resilience to stress. In addition, by pairing stimulation with specific sensory inputs, including sounds and visual cues, it can help treat chronic conditions caused by associated poorly functioning brain networks. Its first preclinical study, which has recently received ethics approval, is for the potential treatment of tinnitus. By pairing stimulation with specific sounds, MindSpire aims to rewire faulty audio signals that result in the unwanted buzzing and hissing sounds of tinnitus. MindSpire and its VR partner, Rescape Health, have recently secured an Innovate UK MindSet grant to combine VNS with immersive visual experiences in chronic pain patients suffering from depression and anxiety. This project is now advancing the concept of stand alone immersive audio-based VNS therapy (IA-VNS), where vagus nerve stimulation is paired with a variety of sound experiences tailored specifically for people with anxiety disorders who are seeking a personal, convenient & drug free solution. MindSpire's approach to pairing VNS with tailored sound experiences represents a novel and promising solution to address this need. By leveraging cutting-edge neurotechnology and personalised therapy, MindSpire aims to provide a new avenue for managing anxiety disorders, ultimately improving the lives of millions of individuals affected by this pervasive condition.

Rescape has been deploying immersive therapies to treat patients' pain and anxiety for over 4 years with a class 1 medical device called DR.VR(r) - we have already licenced our solution to over 80 NHS locations. Our project innovation will combine closed-loop Vagus Nerve Stimulation with Virtual Reality therapies to amplify the benefits of both treatments in reducing depression and anxiety in Chronic pain sufferers. As many as 85% of people who suffer from chronic pain also suffer from a mental health condition, this could be as many as 11.5 million people in the UK. Transcutaneous vagus nerve stimulation (taVNS) has research evidence for efficacy in several mental and medical health issues, such as Depression, Disorders of consciousness, Epilepsy, Cardiovascular Diseases, Digestive system Diseases and Parkinson's disease. It works through the increase of parasympathetic activity (our rest and digest response) which leads to an increased immune response and a reduction of stress and other important body regulation. We believe by using VR in tandem with VNS we can significantly reduce a patient's depression or anxiety -- and even pain in some patients. Chronic pain guidance, in recent years, acknowledges factors other than just physical issues, such as mental health issues and a patient's environment or situation have an impact, this is called the biopsychosocial model. Shockingly an NHS report highlighted that all chronic pain clinics should be supporting this holistic model -- the report found that only 40% of clinics do more than address a patient's physical issues. Both our therapies have shown great promise, and Rescape is excited to collaborate with Mindspire whose patent-pending technology combined with our XR solutions will provide a unique offering. This project will increase the depth of knowledge and advance the learnings for both organisations. Rescape has already partnered with Dr Steffert from Mindspire. We used sensors to take different readings of a patient's body and empowered patients to exert control over the virtual environment, connecting bodies and minds. For example, by slowing their breathing, flowers grew in a meadow they were sitting in. The more their body changed the more flowers grew, giving the patient a unique and innovative feeling of control. The aim of this project is to demonstrate the innovation's viability and usability, working beside patients and staff. This will start a journey to initially create a consumer product and later a medical device capable of helping thousands of patients worldwide.

This project will see MindSpire's highly innovative bioelectronic headset for personalised vagus nerve stimulation move one step closer to market. The project starts with the final testing of electrode materials and locations on the ear before moving on to consolidate past hardware and software innovations into a unified, functional prototype for real time closed loop vagus nerve stimulation. Integrated with essential chipsets and components, this prototype will undergo rigorous testing to validate its real-time functionality, setting the foundation for clinical validation and securing onward investment. To ensure the product's form factor also aligns with users needs, fully 3D printed design models of the headset with its accompanying earpiece will be co-designed. The project will finish with gathering of user-centric feedback, ensuring invaluable insights to refine design assumptions, preparing for the next stage of a fully miniaturised prototype and design for manufacture.

MindSpire proposes an easy to adopt early biomarker of the Coronavirus infection that can be detected days before symptoms appear. The use of Heart Rate Variability (HRV), a measure of the variation in time between each heartbeat, reflects the ability of the heart to respond to different situations and can react to stress or illness before any changes in resting heart rate are seen. This makes it a very powerful signal providing insights into stress and recovery status; early data has already suggested its sensitivity to infection from the Coronavirus. In this highly innovative project, collaborating with an international scientific team, we will be assessing the use of existing phone based apps and fitness trackers for measuring HRV, demonstrating the change (decrease) in HRV, preparing a rapid peer based clinical review and setting out proposals for global roll out and integration within existing NHS screening tools. To take forward a clinical review, we will use “extension for impact” funding to build a software platform we can use for a study. This will also allow us to generate further insights into the actionable intelligence that will drive user compliance and utility. In addition to preparing the ground for an early warning system for COVID and other viral infections, including flu, we will also be able to pivot into a consumer facing app using HRV biofeedback as a tool to reduce stress, anxiety, known to be significantly higher due to the pandemic.