Ruishen'an Medical Submits IPO Prospectus Highlighting Its Implantable Spinal Cord Stimulator System for Spastic Dystonia

Basic Information

Beijing Tiantan Hospital, Capital Medical UniversityNeurosurgery: Spinal Cord and SpineWardZhengConducting a Clinical Trial:A Prospective, Multicenter, Blinded, Randomized Controlled Clinical Trial on the Efficacy and Safety of an Implantable Spinal Cord Stimulator System for the Treatment of Spastic Dystonia（RSA202501）, the Principal Investigator (PI) isJia WenqingDirector.

This study has been approved by the Ethics Committee of our hospital and has completed filing with the Provincial Administration (Filing No.:
Su Xie Lin Bei 20260066）, now openly recruiting participants from the public (Patients with Spastic Dystonia）。

The investigational device for this study isImplantable Spinal Cord Stimulator System，By Rishena Medical Co., Ltd.Provide。The implantable spinal cord stimulator system includes an implantable rechargeable spinal cord stimulator, implantable spinal cord stimulation electrodes, implantable spinal cord stimulation extension leads, and a spinal cord stimulation programmer charger.

Eligibility Criteria

1. Age ≥18 years and ≤70 years, regardless of gender;
   
2. Time from onset to diagnosis of spasmodic dystonia ≥ 6 months;
3. Severe spastic dystonia (MAS assessment ≥ Grade 3);
   
4. Patients who are unresponsive to pharmacological and physical therapy;
   
5. Spastic dystonia due to central nervous system injury;
   
6. Possesses basic cognitive comprehension abilities and can follow simple instructions;
   
7. The subject's overall health status is sufficient to withstand the implantation surgery and subsequent device maintenance;
   
8. The subject and their family members possess adequate comprehension and communication skills, voluntarily participate and sign the informed consent form, and are able to cooperate in completing the entire clinical trial.

For other inclusion or exclusion criteria, please consult the study physician.

Registration Method

Address: Beijing Tiantan Hospital, Capital Medical University

Please Note

Initiated by this centerClinical Trial Center ManagementProjects may send ethics-approved recruitment advertisements (in Word format) to the public email address of the Institutional Office., with remarksContact Information, for publishing recruitment advertisements on the official WeChat account.