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An Exploratory Trial on the Efficacy and Safety of Implantable Spinal Cord Stimulator Systems in Treating Gait Disorders in Patients with Multiple System Atrophy

An Exploratory Trial on the Efficacy and Safety of Implantable Spinal Cord Stimulator Systems in Treating Gait Disorders in Patients with Multiple System Atrophy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110994
Enrollment
Unknown
Registered
2025-10-23
Start date
2025-10-31
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrophy of multiple systems

Interventions

Experimental Group:Procedure and Stimulation Protocol Pre-operative Assessment Prior to enrollment, all patients underwent standard pre-operative assessment using standardized scales, which did not i

Sponsors

Department of Neurology, Xuanwu Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: Probable MSA (Probable MSA) that conforms to the 2022 revised version of the International Society for Dyskinesia (MDS) or the 2008 Gilman consensus diagnostic criteria, with gait disorder as the chief complaint; Subtype definition: Clearly diagnosed as MSA-P type (Parkinson's type) or MSA-C type (cerebellar type); 1.The disease course is 1 to 5 years; 2. Gait disorder persists for >=6 months, and there is insufficient response to conventional treatment (levodopa test, rehabilitation training) (UPDRS-III walking project score >=3 points or SARA gait score >=4 points); 3. No complete loss of walking ability (no need to rely on a wheelchair, able to walk independently or with the assistance of a single crutch for >=10 meters); 4. Age: 30 to 75 years old, gender not limited, and signed informed consent form; 5. Not participated in other interventional clinical trials and committed to completing at least 12 months of follow-up;

Exclusion criteria

Exclusion criteria: 1. Severe cardiopulmonary dysfunction (NYHA grade III-IV, COPD GOLD stage 3-4), severe cognitive impairment (MMSE=17 points); 2. There are contraindications for SCS implantation: coagulation dysfunction (INR>1.5), immunosuppressive status, and local skin infection; 3. A pacemaker, defibrillator or other electronic medical device has been implanted in the body; 4. Previously received spinal cord surgery or deep brain stimulation (DBS) treatment; 5. Have used experimental neuroprotective agents (such as riniazole, minocycline) within the past three months; The dosage of dopaminergic drugs is unstable (adjusted by >=30% within the past month). 6. History of alcohol or drug dependence, etc.

Design outcomes

Primary

MeasureTime frame
Gait scale score;

Secondary

MeasureTime frame
Gait Acquisition;Quality of life;Cognitive function;Sleep disorder;

Countries

China

Contacts

Public ContactLin Hua;Zhang Yuqing

Xuanwu Hospital, Capital Medical University

linhuadoctor@163.com+86 135 2016 3017

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026