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Safety and Efficacy of Epidural Spinal Cord Stimulation for Restoring Walking in Spinal Cord Injury

Safety and Efficacy of Epidural Spinal Cord Stimulation for Restoring Walking in Spinal Cord Injury

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122842
Enrollment
Unknown
Registered
2026-04-20
Start date
2025-12-12
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Spinal cord injuries

Interventions

Experimental Group:Epidural spinal cord stimulation

Sponsors

The Second Affiliated Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age: 16 - 65 years old; 2. Spinal cord injury caused by trauma, with a duration of >= 6 months and = 1 level; 9. Percutaneous spinal cord electrical stimulation at the thoracic 12 and lumbar 1 segments can induce obvious electromyographic waveforms of lower limb muscle groups such as the biceps femoris, semitendinosus, gastrocnemius, and anterior tibialis; 10. Participants voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with necessary postoperative rehabilitation training, examinations, and follow-up.

Exclusion criteria

Exclusion criteria: 1. Having a history of myocardial infarction or stroke within the past 6 months; 2. Diagnosed with mental disorders such as depression, with suicidal thoughts/risk; 3. Currently pregnant or planning to get pregnant during the study period; 4. Having a bleeding tendency or coagulation dysfunction (prothrombin time >= 18 seconds); 5. Having a history of alcohol or drug abuse or dependence; 6. Having intellectual disability, cognitive dysfunction or personality disorder; 7. Having other chronic diseases that may affect recovery (such as severe fractures, liver and kidney failure, severe anemia, etc.); 8. Implanted with a cardiac pacemaker, cardioverter defibrillator or defibrillator; 9. In addition to the above, there are other situations deemed inappropriate by the researchers.

Design outcomes

Primary

MeasureTime frame
Spinal Cord Injury Independence Scale;Spinal Cord Injury Walking Index Score (WISCI II);Adverse Events;

Secondary

MeasureTime frame
Modified Ashworth Scale;Functional Independence Scale;International Standard for Neurological Classification of Spinal Cord Injury;Penn Spasticity Frequency Scale;Pain VAS;

Countries

China

Contacts

Public ContactJunming Zhu

The Second Affiliated Hospital of Zhejiang University School of Medicine

dr.zhujunming@zju.edu.cn+86 571 8778 4716

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026