Multicenter Clinical Trial of Implantable Closed-Loop Spinal Cord Stimulation System for Chronic Intractable Pain Successfully Launched with Promising Early Results
Rishena Medical
Implantable Medical Device R&D and Production Manufacturer
Recently, a study aimed to evaluateEffectiveness and Safety of Implantable Closed-Loop Spinal Cord Stimulator System for Chronic Intractable PainThe multi-center registration clinical trial has been officially launched at multiple top medical centers across China. The study is led byFan Bifa, Department of Pain Medicine, China-Japan Friendship HospitalLed by the professor as the principal investigator, in collaboration withGulou Hospital Affiliated to Medical School of Nanjing University(Pain Department,Tao GaojianProfessor),The First Affiliated Hospital of Soochow University(Pain Department,Xiaohong JinProfessor),Peking University Third Hospital(Pain Department,Li ShuiqingProfessor),The Second Hospital of Hebei Medical University(Pain Department,Liu Guangzhao / Ren Yu'eProfessor),Shenzhen University Affiliated South China Hospital(Neurology Center,Tao WeiProfessor),General Hospital of Eastern Theater Command, PLA(Pain Department,Jin YiProfessor),The First Affiliated Hospital of Zhengzhou University(Pain Department,Fan Xiao ChongProfessor),Renmin Hospital of Wuhan University(Pain Department,Yifan JiaProfessor),The First Hospital of Lanzhou University(Pain Department,Xie ZhaohuiProfessor),Beijing Tiantan Hospital, Capital Medical University(Neurosurgery,Yang AnchaoProfessor),Renne Hospital Affiliated to Shanghai Jiao Tong University School of Medicine(Pain Department,Fan YinghuiProfessor),West China Hospital of Sichuan University(Neurosurgery,Xu JianguoProfessor),Beijing Bo'ai Hospital(Spinal Cord Surgery,Wang FangyongProfessor) and other centers jointly conducted (the above clinical trial centers are sorted by start time).
The first group of patients in this study have successfully completed the implant surgery. Postoperative follow-up shows that their chronic refractory pain has been significantly alleviated, and the patients' quality of life has greatly improved.
Chronic pain, especially chronic refractory pain that persists for more than three months and is difficult to relieve through standard conservative treatments, not only severely impacts patients' physiological functions and quality of life but also imposes a heavy economic and caregiving burden on families and society. Traditional drug therapies have limitations such as strong dependency and numerous side effects, while surgical interventions often involve significant trauma and high risks. Open-loop spinal cord stimulation (SCS), as a mature neuro-modulation technology, has offered new hope to many patients with drug-resistant pain. However, it also has drawbacks, including poor adaptability, the inability to dynamically adjust based on patients’ real-time physiological conditions and pain sensations, potentially imprecise effects, and challenges in achieving personalized optimal stimulation patterns.
To address the limitations of SCS, Rishena Medical Co., Ltd., based on its mature implantable neurostimulator technology platform, has successfully developed an implantable closed-loop spinal cord stimulation system. The core innovation of this system lies in the introduction of a "closed-loop feedback" mechanism, which can collect and measure the evoked compound action potentials (ECAP) of the dorsal column nerve fibers induced by stimulation in real time after each electrical pulse output. The system automatically analyzes the amplitude of the ECAP through intelligent algorithms and compares it with a preset ideal therapeutic range, then dynamically adjusts the intensity (amplitude) of the next output pulse to ensure that each stimulation pulse effectively and stably activates the target nerve fibers. When changes in the patient's physical activity or physiological state cause a shift in the relative position between the spinal cord and the electrode, the system provides real-time feedback and adjusts the stimulation current to ensure that spinal cord activation remains within the effective therapeutic range, thereby continuously suppressing pain processing pathways and maximizing treatment efficacy.
ECAPSignal Acquisition
After the clinical trial was launched, each center quickly initiated patient screening and enrollment work. Currently,Tao Gaojian, Department of Pain Management, Drum Tower Hospital Affiliated to Nanjing University Medical SchoolThe director team has successfully performed the implantation surgery of the implantable closed-loop spinal cord stimulator system on the first batch of patients, who have smoothly passed the perioperative period, with significant relief of chronic intractable pain.
The successful initiation and initial application of the clinical trial for the implantable closed-loop spinal cord stimulation system marks another significant milestone in the innovation journey of closed-loop active implantable medical devices, heralding the potential entry into a more intelligent and precise "closed-loop era" for chronic pain treatment. With further advancement of research and accumulation of more data, closed-loop SCS technology is expected to play an even greater role in enhancing analgesic efficacy, improving long-term patient outcomes, and optimizing healthcare resource utilization, ultimately benefiting a wide range of patients with chronic pain by helping them break free from the shackles of pain and improve their quality of life.
This registered clinical trial is currently underway. If you or your friends are interested in participating in this study, you can visit the outpatient department of the hospital mentioned above for more detailed consultation.
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