NeuroSole

Parkinson's disease (PD) has the fastest-rising prevalence of all neurological diseases, affecting up to 10 million individuals. In addition, in 2022 nearly 90,000 patients have been diagnosed with Parkinson’s, a steep 50% increase from preceding years, making it the second most common neurodegenerative disease in the United States. 

For diagnosis, patients have to go through numerous exhaustive, expensive, and time-consuming tests such as DaTscan, MRI, and PET scans to rule out other diseases. Patients also spend an average of $2,500 to obtain the necessary examinations before diagnosis. The symptoms of Parkinson’s are also similar to that of Lewy body dementia, and muscular dystrophy, making it even harder for doctors to diagnose Parkinson’s. 

Currently, Parkinson's is misdiagnosed up to 30% of the time and according to Parkinson’s UK 34% of people that were misdiagnosed reported a decline in health. This leads many patients to develop Parkinson's symptoms 1-2 years before their official diagnosis, leading to worsened conditions and chronic symptoms. Moreover, according to ParkinsonsDisease.net, “diagnosing PD early is important because treatments such as levodopa/carbidopa are more effective when administered early on in the disease.” Thus, the increase in  late or misdiagnosis leads to ineffectiveness of medications and ongoing progression of the disease. 

Altogether, due to a lack of an accessible, affordable, and accurate diagnostic system available for patients in the early stages prevents them from taking further action in order to slow the progression of the disease.

NeuroSole is a novel diagnostic tool that utilizes a 1D convolutional neural networks model to analyze Parkinsonian gait patterns, which are one of the earliest symptoms in Parkinson’s. To obtain data points regarding one's gait, each pair of NeuroSole insoles are embedded with 12 pressure sensors to transmit the ground reaction forces to the 1D convolutional neural network model. The sensors placed in the insoles of the shoe record the pressure points during each phase of the gait cycle. To accurately assess the patient's gait, six sensors are positioned in each insole: one sensor near the toes, two in the metatarsal region, one in the midfoot, and two near the heel. The data points collected by the sensors are sent from the Arduino Uno to the Raspberry Pi which then sends the data to the cloud where the data is processed and used to detect the likelihood of developing Parkinson’s using the 1D-Convnet model.   

NeuroSole comes with the insoles and a free downloadable app. The app displays the results of the examination, allows users to monitor symptoms, and share results with caregivers. To use NeuroSole, the user has to download the app on their mobile, insert the insoles into their shoes and enable the app to start tracking. After a short walk of 2-3 minutes, the app immediately reports the likelihood of developing PD and if desired the results can be shared with caregivers. Patients can use our product on a regular basis to monitor the progression.  

To develop the model, the 1D CNN algorithm was used as it can perform activity recognition tasks such as standing, walking, or jumping. We also used software applications like the Raspberry Pi OS and the Arduino IDE to read in the sensor values and develop the model. 

Demo video: https://youtu.be/2ue34Lw69H0

The demographics of our primary target market encompass individuals who are 50+ across the globe. The psychographics are individuals looking for immediate, cheap, and non-invasive alternatives to diagnose Parkinson’s in its early stages. This also includes individuals who are cautious about their health, have poor health records, or could possibly inherit the disease from close family members. The secondary target market includes disorder movement specialists and neurologists who want to verify the diagnosis results and monitor their patient's symptoms and progression over long gaps between visits. Our very first customers include patients at local hospitals, neurologist's clinics, and the elderly individuals in our local community. 

Currently our target market doesn’t have other alternatives on the market to accurately diagnose Parkinson’s in its early stages in the comfort of the homes. Our product aims to provide an effective solution where users can diagnose in the comfort of the homes while intervening at the proper time to make treatments such as Carbidopa-levodopa more effective at managing symptoms. Through our product, we hope to increase the effectiveness of medication and decrease the number of patients that are misdiagnosed in the coming years. In the long run, NeuroSole can provide individuals with peace of mind and allow them to lead active and independent lives. 

My twin sister and I have decided to work together on creating a life-changing product that draws from our shared life experiences and knowledge. This problem matters to us because our grandfather was diagnosed with stage 3 Parkinson's, which made us recognize the invaluable need for tools that can help patients to diagnose neurological diseases like Parkinson’s in its early stages. The community of individuals with neurodegenerative diseases remain very close to our heart. Our experience motivates us to create a product that will assist millions of patients worldwide to take necessary medications at the appropriate time. Our product will aid neurologists by streamlining the diagnostic process and simultaneously helping patients take preventative care as needed. 

Currently, our product was also recognized by the Global Conrad Challenge where our project received the Power Pitch award from among 950+ teams. In addition, we have already applied for a provisional patent on the integration of sensors onto the insoles. Furthermore, we have a strong background in computer science as we both advanced to the finals in ACSL, and are currently silver contestants in USACO. Moreover, we have strong fundamentals in business and have been competitively successful in DECA by placing in ICDC, which will allow us to build a strong business model for our company. In addition, in our first two years of high school we performed extensive research on neurodegenerative disease similar to Parkinson’s and received statistically significant results and even published the results in the Harvard Journal of Emerging Investigators. We have also been recognized for our research on neurodegenerative disorders by the city council and mayor. All of this will allow us to develop a one-of-a-kind product that caters to our customers by solving the current drawbacks in the market. 

Our solution is in the prototype stages because we have successfully developed our first MVP product of the insoles with the integration of the sensors and the app where the results will be displayed. Currently we are in the process of continuing to refine and develop our product by discussing with local neurologists and have also conducted a survey of the local elderly members and found great interest from them to try our product. We are also working on testing the accuracy of our AI model. 

As of now NeuroSole does not serve any customers. However, next year, our first year of launching into the market, we hope to serve an average of 800 users which will be a combination of patients and doctors, neurologists, physiotherapists who want to utilize NeuroSole in the diagnostic and recovery process. The customers will utilize the diagnostic tool, the insoles, and the free downloadable app to monitor, share and record their results. We hope to provide these individuals with an early diagnosis allowing them to obtain necessary medications to prevent worsening of conditions. 

NeuroSole must receive the necessary approvals and meet the regulatory standards before entering the market. Navigating the regulatory landscape and obtaining necessary approvals can be a lengthy and resource-intensive process. Winning Solve would be greatly beneficial as it would help NeuroSole gain access to experts who can help provide guidance and support through the regulatory pathway. In addition, NeuroSole requires a well-defined commercialization strategy. Solve can provide exposure and access to the network of potential partners, investors, and industry experts who can offer guidance on market entry strategies, business development, and scaling our solution effectively.

Before we launch our products to the market, we will also need to test the accuracy and functionality of our product. Solve will allow us to connect with other institutions in the medical and healthcare field, along with other healthcare professionals which can facilitate collaboration and recruitment of participants for clinical studies. Solve can also provide monetary support through grants or access to investors interested in supporting innovative healthcare solutions. This can help us refine our device, conduct further research, and accelerate commercialization. Connections with experts in the healthcare field can increase our market scope and help us more effectively reach our customers. Overall, winning the Solve competition and receiving advice and guidance can significantly benefit NeuroSole. We believe that Solve can provide regulatory insights, clinical validation support, and financial resources, all of which are essential for overcoming challenges and successfully bringing our solution to patients and healthcare providers.

NeuroSole is a portable, cheap, non-invasive, and easy-to-use early diagnostic system for Parkinson’s, and is currently the only diagnostic tool on the market to utilize vertical ground reaction forces from insoles to analyze Parkinsonian gait. NeuroSole stands out because of three key values which are accessibility, affordability, and accuracy. NeuroSole can transform the diagnostic market by opening options for customers to perform at-home diagnosis with accurate results within minutes and also enable doctors to utilize NeuroSole in their diagnostic process.

In addition, other products on the market like the Parkinson’s Toolkit app provide medical professionals with clinical practice guides to treat PD, but they do not provide quantitative real-time data to diagnose Parkinson’s like NeuroSole. Other diagnostic options like brain scans and neurological tests can be harmful, expensive, and time-consuming. In contrast, our product is non-invasive and can display results within minutes of walking. In addition, our product has myriad features to set us apart from emerging competitors such as reporting results to caregivers and regularly monitoring their symptoms. Altogether, NeuroSole provides our customers with a one-of-a-kind product that is accurate, affordable, and easy-to-use. Neurosole is a product that once placed in the hands of patients and neurologists can revolutionize the industry of diagnostics for parkisons.

At NeuroSole, our goal is to reduce the number of patients who are misdiagnosed for Parkinson's and help neurologists diagnose Parkinson's at the early stages in a non-invasive, quick, and simple method. In the coming years we hope to decrease the number of patients who are misdiagnosed by 5% to 10%. Our product aims to increase the average lifetime of Parkinson's disease patients by intervening at the proper time and making treatments such as Carbidopa-levodopa more effective at managing symptoms. According to ParkinsonsDisease.net, “diagnosing PD early is important because treatments such as levodopa/carbidopa are more effective when administered early on in the disease.” Through our products we hope to instill hope and confidence in patients and allow them to lead active and independent lives, by addressing  the issues at an early stage and continuously monitor their progression.

Some of the factors that can be used to measure progress towards our goals include the number of people diagnosed early using NeuroSole. The time to diagnosis after initial symptoms can be recorded to verify that NeuroSole intervenes in the early stages. The goal of this early diagnostic device is to reduce the time taken to diagnose the condition, and tracking this metric can help assess the impact of the device in achieving this goal. Another metric includes the accuracy of diagnosis. The device's ability to accurately diagnose Parkinson's disease can be tracked through data analysis and feedback from patients and healthcare professionals. Finally, patient satisfaction can also be monitored as positive feedback from patients can help demonstrate the device's impact in improving the quality of life for those with Parkinson's disease. Overall, these metrics can be tracked over time and compared to the company's impact goals to assess NeuroSole progress and adjust strategies as necessary.

We expect our solution to have an impact on the problems by focusing the 3 A’s: accuracy, accessibility and affordability. In order to ensure a positive impact of our products on our customer we plan to focus on ensuring high accuracy through extensive clinical trials and approvals before launching into the market. We also plan to use transfer learning to continue to train and redefine the parameters of our AI model. We also plan to focus on ensuring high accessibility of our products by making them portable, and easy to use, without intervening with other activities. Thus, our product can be used simultaneously as the user walks, not intervening with other activities and plans. Finally, we focus on being an affordable device by charging $250 for a pair of insoles and $5 for a one time download of the app. In addition, in the future we plan on incorporating a renting option for 1-3 days for $30 to $60 to reduce the financial burden faced by patients and instead provide a cost effective solution with long term uses. 

We also conducted a survey of the local elderly members on the interest and willingness to try our product and found that over 70% were willing to use it. In addition, we have also taken the steps to discuss our future plans and the current functionality, comfort and uses of our MVP with our local neurologists. As this feedback can ensure a high customer satisfaction before we launch into the market.

NeuroSole is a novel diagnostic tool that finds abnormalities in the walk by utilizing gait patterns, one of the earliest symptoms in Parkinson’s. To develop the hardware of our product, we embedded 12 pressure sensors in a pair of insoles to transmit the ground reaction forces to the 1D convolutional neural network model. The sensors record the pressure points during each phase of the gait cycle. To accurately assess the patient's gait, six sensors are positioned in each insole: one sensor near the toes, two in the metatarsal region, one in the midfoot, and two near the heel. The data points collected by the sensors are sent to the Arduino Uno which serves as an analog-to-digital converter. The Arduino Uno digitizes the sensor signal and transmits it via a serial protocol to the Raspberry Pi. The Raspberry Pi then sends the data to the cloud where the data is processed and used to detect the likelihood of developing Parkinson’s using the 1D-Convnet model.   

In order to develop the AI model, the Gait in Parkinson's Disease dataset was obtained from PhysioNet. The dataset is a collection of multichannel recordings from force sensors beneath the feet of 93 patients with Parkinson's Disease and 73 healthy controls. The dataset contains the vertical component of the ground reaction forces from the sensors placed on the insole of each foot. For the data pre-processing, the first and last 15 seconds of the walking were removed to ignore the starting and stopping disturbances. Furthermore, for the feature extraction, the most prominent features were analyzed such as swing time, stride time, gait asymmetry, and double stance time for both feet. In order to build and train the model we utilized the 1D convolutional neural networks algorithm.  

The AI model reports the likelihood of developing Parkinson’s on the NeuroSole app after the user walks for a few minutes. The app is currently being developed where the users can automatically share results to caregivers and monitor their past test results. 

At NeuroSole, we look forward to creating a diverse workforce of people from all backgrounds from across the globe. This will allow us to not only take in the ideas and perspectives from different people, but also create a workforce that is open to all people regardless of their ethnicity, and background. We hope to work towards making our products accessible in many locations across the globe to provide people in developing nations without access to proper medical care. This will empower individuals to take timely action and better prepare for their future. 

Our business plans to effectively utilize a mix of direct-to-consumer models through our eCommerce website and partner with retail stores to attract the most number of customers. The customers can purchase the insoles and download the app for free. 

Growth Model: Phase 1 - Product Development & Refinement: In this phase, we will focus on prototyping and refining our product with the feedback we will receive from members in the California Parkinson Foundation, and local neurologists. We will also work on optimizing the website for SEO and integrating calls to action. 

Phase 2 - Marketing & Brand Awareness: Initially, to educate and attract customers we plan to utilize social media platforms with our focus on impression marketing. Throughout the initial stages, we hope to create flyers to post outside of clinics and connect with physicians who can recommend NeuroSole to their patients. Gaining the endorsement of medical professionals will significantly help to improve our brand image and increase credibility.  

Phase 3 - Scaling & Market Expansion: In the coming years we look forward to expanding our market to neurodegenerative diseases similar to PD like Amyotrophic Lateral Sclerosis, Charcot-Marie-Tooth, and Huntington’s disease. One of the most prominent symptoms of these diseases is also gait, allowing us to utilize the same technology of inbuilt sensors in insoles to detect symptoms. This will drastically increase our customer base, and make our products more inclusive to all neurodegenerative diseases.

Our four main sources of funding include angel investors, SBIR and STTR funds, venture capitalists, and crowdfunding. To procure the initial funds, we plan to launch a crowdfunding campaign with a goal of $30,000. SBIR and STTR grants are a great fit as they will not dilute our capital and will allow us to gain guidance from experts. In addition, we plan to partner with Polaris and Aberdare venture capitalists in the healthcare sector to gain further funding, expand our reach, and gain insightful feedback.