Skip to content

Study on the safety and effectiveness of brain controlled closed-loop epidural electrical stimulation for patients with lower limb paralysis after spinal cord injury

Study on the safety and effectiveness of brain controlled closed-loop epidural electrical stimulation for patients with lower limb paralysis after spinal cord injury

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095359
Enrollment
Unknown
Registered
2025-01-06
Start date
2025-01-07
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

Spinal cord injury

Interventions

Experimental group:Brain controlled closed-loop epidural electrical stimulation

Sponsors

Zhongshan Hospital affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. 18-65 years old (no gender requirement); 2. The clinical diagnosis is paraplegia after spinal cord injury; 3.6 months or more after spinal cord injury (spinal shock period has passed, with no significant recovery or deterioration of sensory and motor functions); 4. Injury level: T12 vertebral body level or above, with normal upper limb motor function; 5. Unable to stand or walk independently; 6. According to the American Spinal Cord Injury Association Injury Scale (ASIA), spinal cord injuries are classified as grades B, C, and D;

Exclusion criteria

Exclusion criteria: 1. Pregnant women; 2. Drug or alcohol abuse; 3. Suffering from diseases that limit the motor ability of lower limbs: diabetes foot, severe osteoporosis, contracture deformity of lower limb joints, spasm, fracture (progressive/deformation due to fracture), and hospitalization due to autonomic reflex disturbance in recent 3 months; 4. Neurological disorders/injuries: traumatic brain injury, epilepsy, neurodegenerative diseases or neuropathy, severe anxiety and depression, suicidal tendencies; 5. There are surgical contraindications: infectious diseases, unstable angina pectoris, serious arrhythmia and other heart diseases; Immune system diseases and important organ diseases; Coagulation disorders and bleeding tendency; Ankylosing spondylitis and malignant tumors; Instability of the spine and narrowing of the spinal canal; 6. Unable to follow research procedures, such as language problems, cognitive impairments, psychological disorders, dementia, etc;

Design outcomes

Primary

MeasureTime frame
American Spinal Cord Injury Association Injury Scale (ASIA) score;Muscle strength of lower limb iliopsoas and quadriceps femoris;Gravity assisted ratio required for standing;

Secondary

MeasureTime frame
The electromyographic amplitude of the iliopsoas and quadriceps muscles in the lower limbs during active exercise;Standing ability and standing time;The amplitude and latency of the sensory evoked potential;

Countries

China

Contacts

Public ContactJing Ding

Zhongshan Hospital affiliated to Fudan University

ding.jing@zs-hospital.sh.cn+86 135 0191 7091

Outcome results

None listed

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