ChinaMed NeuroTech Initiates Multicenter Clinical Trial to Establish Normative Quantitative Parameters for Neurological Function in Chinese Population
On August 28, 2021, Zhongke Ruiyi initiated multi-center clinical enrollment for the investigational clinical trial of its Quantitative Evaluation System for Neurological Function. This clinical trial aims to establish a national norm, i.e., a data model of the normal population in China, so as to define the reference range of neurological function for the healthy population in the Quantitative Evaluation System for Neurological Function.
According to the introduction, this investigator-initiated clinical trial is led by Peking Union Medical College Hospital, with Professor Zhu Yicheng, Director of the Department of Neurology, serving as the Principal Investigator (PI). The other 12 leading domestic neurology hospitals participating in the study include: Nanjing Drum Tower Hospital, Xiangya Hospital of Central South University, The Third Affiliated Hospital of Sun Yat-sen University, West China Hospital of Sichuan University, The Second Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital of Zhengzhou University, The Second Hospital of Hebei Medical University, Wuhan Union Hospital, Fujian Provincial Hospital, The Affiliated Hospital of Guizhou Medical University, The First Affiliated Hospital of Anhui Medical University, and Beijing Tsinghua Changgung Hospital.
Zhongke Ruiyi stated, “These 13 hospitals are the top neurological hospitals in China, covering 12 provinces and municipalities across the country, and all are leading Grade A tertiary hospitals within their respective regions.”
Public information indicates that Zhongke Ruiyi is an innovative, fast-growing medical technology company incubated by the Chinese Academy of Sciences (CAS). Leveraging frontier neuroscience achievements honored with the National Science and Technology Progress Award, and pooling the R&D strengths of the CAS and Peking Union Medical College Hospital, the company provides intelligent solutions covering the full spectrum of screening, diagnosis, treatment, and research for neurological disorders. Currently, Zhongke Ruiyi has developed two solutions: quantitative assessment of motor function and quantitative evaluation of cognitive function. These solutions are designed to serve as infrastructure for neurology departments in hospitals at all levels, assisting physicians in more objectively assessing, screening, diagnosing, and treating patients with neurological disorders.
The diagnosis of human diseases is often based on the description of physiological functions. For example, diseases such as anemia can be diagnosed by counting the number of red blood cells and measuring the concentration of hemoglobin in the blood. With the progression of population aging, a series of neurological disorders, including cerebrovascular disease, Alzheimer’s disease, and Parkinson’s disease, have become the leading causes threatening human health, resulting in disability and death. The uniqueness of the nervous system determines the complexity and difficulty in describing neural functions. Consequently, achieving accurate diagnosis and intervention for neurological diseases based on these descriptions remains a significant challenge in the fields of biology and medicine.
The widespread clinical issues of delayed diagnosis and undertreatment stem from the current reliance on physicians’ subjective judgments in diagnosing neurological disorders. In routine clinical practice, physicians make diagnostic decisions based on medical history taking, visual observation, analysis of semi-quantitative classic scales such as the MMSE and MoCA completed by patients, and their own clinical experience. This approach, being dependent on empirical judgment, is associated with high uncertainty and a high rate of missed diagnoses.
Meanwhile, the uneven distribution of medical resources in China and the lack of diagnostic and therapeutic experience among primary care neurologists have led to high rates of missed and misdiagnoses of neurological disorders. On the other hand, the onset of neurological diseases, particularly neurodegenerative disorders, is often insidious, with a prolonged disease course. Many patients’ families are unaware of the condition, mistakenly attributing symptoms to “old age and senility,” thereby missing the optimal window for diagnosis and treatment. Consequently, patients often present to physicians only when the disease has already progressed to the middle or late stages.
Data indicates that the functions of the nervous system primarily encompass cognitive and motor functions. The diagnosis of neurological disorders necessitates an evaluation of both cognitive and motor functions. To address challenges such as high diagnostic uncertainty, reliance on subjective experience, and high rates of missed diagnoses in neurological diseases, Zhongke Ruiyi has developed two solutions: quantitative assessment of cognitive function and quantitative assessment of motor function.
Dr. Fan Xiangmin, CEO of Zhongke Ruiyi and an expert in the Chinese Academy of Sciences’ “Hundred Talents Program,” stated, “The quantitative assessment system for cognitive function that we have developed is a suite of software tools, primarily comprising more than 20 instruments designed to evaluate different cognitive domains in patients. These tools can assess multiple core cognitive domains, including memory, reasoning, language, attention, and orientation, and provide corresponding evaluation parameters for users.”
In terms of application, the system analyzes users’ cognitive domains through assessment tools designed like engaging brain-training games. Behind this seemingly simple and entertaining interface lies the culmination of years of research by a joint R&D team comprising authoritative neuroscience experts from Peking Union Medical College Hospital and human-computer interaction specialists from the Chinese Academy of Sciences. Upon completion of the full suite of assessments, the system provides a quantitative evaluation.
Previously, physicians assigned scores based on semi-quantitative classical scales through patient interviews and inquiries. However, for the same patient, scores and diagnoses provided by multiple neurologists may be inconsistent, representing a significant pain point in clinical practice. The digital cognitive function measurement system developed by CAS RayMed is poised to transform this landscape.
Specifically, Zhongke Ruiyi has standardized the traditional testing process through its quantitative assessment system for cognitive function. Upon completing the standardized evaluation, users receive a quantitative description of their neurological function. Similar to blood tests that provide specific parameters such as white and red blood cell counts, this system offers measurable insights into cognitive health. Following this clinical trial, Zhongke Ruiyi will establish reference ranges for cognitive function parameters in the healthy population, thereby providing essential infrastructure for neurologists to quantitatively assess neurological disorders.
Unlike quantitative assessment of cognitive function, which relies solely on software systems, quantitative assessment of motor function is conducted using an integrated hardware-software device. Based on classical medical theories and extensive clinical experience, and leveraging the capabilities of advanced motion capture sensors, this device establishes a series of standardized test protocols, including gait analysis, the Timed Up and Go (TUG) test, the Five Times Sit-to-Stand test, the Romberg test, diadochokinesia testing, and the finger-to-nose test. It enables standardized evaluation of upper and lower limb motor function, balance, and coordination.
Previously, assessments of users’ gait and balance relied on physicians’ subjective impressions rather than objective, quantitative evaluation. Today, Zhongke Ruiyi leverages deep visual perception and motion capture technologies to precisely digitize and reconstruct the execution of standardized assessment maneuvers, accurately analyzing kinematic parameters and features with clinical evaluative significance. This approach establishes a quantitative parameter system that effectively characterizes motor function, enabling objective and comprehensive description and assessment of motor performance.
Specifically, the quantitative assessment system for motor function captures human body images using a 3D structured light sensor and employs algorithms to identify key anatomical landmarks, including the head, neck, shoulders, wrists, and joints, thereby creating a “digital human.” This “digital human” acts as a three-dimensional mirror, digitizing the user’s movements and postures. Furthermore, based on the actions of the “digital human,” the system quantitatively describes various kinematic parameters, such as stride length, step width, step length, and gait speed.
Previously, a few products relied on wearable sensor devices or high-speed camera systems for image recognition. However, such approaches are expensive and time-consuming to set up. In contrast, Zhongke Ruiyi’s Quantitative Assessment System for Motor Function captures and analyzes 3D human body images using advanced computer vision systems and algorithms to create a “digital human,” without the need for any wearable sensors.
Dr. Fan Xiangmin stated, “Leveraging our strengths in technological innovation, clinical evidence, and functional user experience, we aim to establish two solutions—quantitative assessment of cognitive function and quantitative assessment of motor function—as the foundational infrastructure for next-generation neurology, thereby serving healthcare providers and patients who require evaluation and diagnosis of neurological disorders.”
According to the introduction, this investigational clinical trial will enroll more than 5,000 participants and is primarily intended to establish national normative reference values for quantitative parameters of neurological function.
To ensure data accuracy, the trial will establish numerous subgroups based on criteria such as sex, age, and education level—for example, 50-year-old males with junior high school education and 60-year-old females with senior high school education. These precise stratifications will define accurate reference ranges, providing critical guidance for neurologists in subsequent patient diagnoses.
Upon completion of this clinical trial, Zhongke Ruiyi will establish a comprehensive quantitative evaluation system for neurological function, encompassing assessment hardware devices, software platforms, parameter systems, and normal reference ranges (i.e., population norms). This multicenter clinical trial will accelerate the regulatory registration, market launch, and clinical adoption of two solutions: the Ruimotion Quantitative Motor Function Assessment System and the Ruinao Digital Cognitive Function Measurement System.
In the future, following the market launch of Zhongke Ruiyi’s two systems for the quantitative assessment of motor and cognitive functions, they are poised to become foundational infrastructure in next-generation neurology departments. By providing quantitative descriptions of patients’ neurological functions, these systems will assist neurologists in making accurate diagnoses and precise evaluations for individuals with neurological disorders, ultimately establishing standardized diagnostic tools for neurological diseases akin to complete blood counts and electrocardiograms.
It can be said that this multicenter clinical trial represents a small step for human medicine, but a giant leap toward the standardization of diagnosis and assessment in the field of neurological disorders.