Global First: DomeTech Completes First Patient Enrollment in Pivotal TI-Based Depression Clinical Trial with Beijing Anding Hospital and Over 10 Leading Mental Health Centers

Recently,NeurodomeHand in HandLed by Beijing Anding Hospital, Capital Medical University, and more than 10 top psychiatric research centers in ChinaThe GCP clinical trial for non-invasive neuromodulation in depression, jointly conducted, has reached a significant milestone: the world's first participant meeting the enrollment criteria has officially received treatment, marking an important step for the device independently developed by Neurodome.Temporal Interference (TI)Non-invasive Deep Brain Precision Neuromodulation Technology Enters a New Phase of Authoritative and Rigorous Validation in the Field of Mental Health. This breakthrough not only offers new treatment possibilities for patients with depression but also further strengthens the clinical implementation capabilities of China-produced advanced neuromodulation technology.

First Patient Enrolled: Focusing on Real Patients, Strictly Adhering to Standard Procedures

The subject enrolled this time is a 42-year-old patient with a disease course of two years. The patient had previously received standardized antidepressant drug treatment and psychological intervention, but the improvement in symptoms was not significant, with persistent marked emotional depression, loss of interest, and impaired social function, consistent with the typical clinical features of depression. After fully understanding the trial protocol, potential risks, and expected benefits, the patient signed the informed consent form and recently officially received Neurodome's TI non-invasive deep brain precision neuromodulation therapy in the GCP-standard treatment environment at Beijing Anding Hospital.

Subjects sign the informed consent under the guidance of the investigator.

The entire enrollment process strictly followed the requirements of the Good Clinical Practice (GCP) guidelines and was completed under the full supervision of the hospital’s ethics committee. From the initial rigorous diagnostic screening and enrollment evaluation to multiple rounds of communication and confirmation before treatment, Neurodome, in collaboration with the Beijing Anding team and multiple centers, established a strong trust relationship with patients, ensuring their complete informed consent and voluntary participation. Currently, standardized follow-up records have been established for the patients, who will subsequently undergo systematic efficacy and safety assessments according to the trial protocol, providing critical data support for the clinical value of the technology.

Subjects received TI treatment

Technical Support: TI Innovative Therapy, Precise Deep Brain Stimulation

The core technology of this clinical trial is the Time Interference (TI) stimulation technology independently developed by Neurodome. This technology precisely focuses on deep neural nuclei by superimposing electric fields of specific frequencies in targeted brain regions, achieving non-invasive deep brain precise neural modulation without damaging superficial tissues.

After thousands of laboratory validations and multiple iterations of product generations, this technology has formed a full-chain solution covering hardware devices, intelligent algorithms, and clinical applications. In the early non-clinical studies, it demonstrated positive potential for improving various psychiatric/neurological disorders. This GCP clinical trial is a crucial step from the laboratory to real-world treatment, laying a solid foundation for subsequent product registration and widespread application.

Neurodome Product Matrix

Powerful Combination: Top Clinical Resources Empower Technology Validation

As the National Center for Psychiatry and the National Clinical Research Center for Mental Health, Beijing Anding Hospital, affiliated with Capital Medical University, boasts a top-tier psychiatric diagnosis and treatment team in China, a comprehensive GCP management system, and profound accumulation and extensive experience in clinical diagnosis, treatment, and research of various mental disorders. This multicenter trial across China is led by Beijing Anding Hospital, affiliated with Capital Medical University.Project Leader: Dean Wang GangNeurodome has long focused on the non-invasive and precise treatment of central nervous system diseases, establishing cooperation with over 200 top clinical centers both in China and internationally, accumulating a vast amount of clinical data in the field of neuromodulation.

"The enrollment of the first subject is an important milestone for the project and a new starting point of hope for patients."Neurodome CEO Dr. Long Li"We will closely collaborate with Beijing Anding Hospital and various research centers, strictly adhere to GCP standards, and advance the trial with a scientific and rigorous attitude, aiming to provide patients with safer and more effective treatment options."

About Neurodome

NeurodomeFounded in2019Year, isThe first in China to practically master and achieve human bodyTINon-invasive Deep Brain Precision NeuromodulationInnovative enterprise, incubated by the Institute of Health and Rehabilitation Science of Xi'an Jiaotong University's School of Life Science, focusing on central-Peripheral Nervous System Diseases and Chronic Mental DisordersNon-invasive, Precise, Deep Brain, Multi-targetDevelopment of treatment solutions. Currently, the company has collaborated with partners in China and abroad.200Multiple top clinical centers collaborate to conduct clinical research, leading the global clinical speed and data accumulation. The company's core technology is the independently developed Time Interference (TI) Stimulation technology that achieves precise deep brain modulation through non-invasive methods, avoiding the risks associated with traditional invasive surgeries, filling a gap in neuro-/A Breakthrough in Non-Invasive Treatments for Psychiatric Disorders. After thousands of experiments and multiple product iterations, Neurodome has developed a comprehensive solution from hardware and algorithms to clinical applications, holding an internationally leading position among similar products and demonstrating outstanding efficacy in the treatment of neuropsychiatric disorders.

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