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Study on the Safety and Efficacy of Closed-Loop Epidural Electrical Stimulation Regulated by Scalp Electroencephalogram for Lower Limb Paralysis Patients after Spinal Cord Injury

Study on the Safety and Efficacy of Closed-Loop Epidural Electrical Stimulation Regulated by Scalp Electroencephalogram for Lower Limb Paralysis Patients after Spinal Cord Injury

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107980
Enrollment
Unknown
Registered
2025-08-21
Start date
2025-08-25
Completion date
Unknown
Last updated
2025-08-25

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:Subjects will undergo implantation surgery of a spinal test stimulator and epidural electrode

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18–60 years (no gender restriction); 2.Clinically diagnosed with paraplegia after spinal cord injury; 3.Six months or more after spinal cord injury (spinal shock phase has passed, with no significant recovery or deterioration in sensory and motor functions); 4.Injury level: above the T12 vertebral level, with normal upper limb motor function; 5.Unable to stand or walk independently; 6.No brain diseases confirmed by cranial MRI examination; 7.Brain electrical decoding rate of >= 40% in task-attempt training for lower limb movement; 8.Able to cooperate with imaging examinations; 9.Having a strong willingness to rehabilitate and good family support; 10.Spinal cord injury graded as A, B, or C according to the American Spinal Injury Association (ASIA) Impairment Scale.

Exclusion criteria

Exclusion criteria: 1.Females who are pregnant; 2.Drug abuse or alcoholism; 3.Diseases restricting lower limb mobility: diseases causing limited hip joint movement such as developmental dysplasia of the hip, diabetic foot, severe osteoporosis, lower limb joint contracture deformity, spasm, fracture (progressive/resulting in deformation due to fracture), hospitalization for autonomic dysreflexia in the past 3 months, etc.; 4.Neurological diseases/injuries: craniocerebral injury, epilepsy, neurodegenerative diseases or neuropathy, severe anxiety and depression, suicidal tendencies; 5.Presence of surgical contraindications: infectious diseases, unstable angina pectoris, severe arrhythmia and other heart diseases; immune system diseases and major organ diseases; coagulation disorders and bleeding tendencies; ankylosing spondylitis, malignant tumors; spinal instability, spinal stenosis; 6.BMI >= 30.0 kg/m^2; 7.Those with cognitive impairment (MMSE 17 points); 8.Those unable to follow the research procedures.

Design outcomes

Primary

MeasureTime frame
American Spinal Injury Association (ASIA);

Secondary

MeasureTime frame
Athworth;3-meter walking time;plantar pressure value;lower limb muscle volume;step length;Visual Analogue Scale (VAS);Sexual Health Inventory for Men (SHIM)/ Sexual Concerns Scale for Women (SCS – W);International Consultation on Incontinence Questionnaire-Short Form (ICI-Q-SF);intestinal function rating scale;

Countries

Chnia

Contacts

Public ContactJing Ding

Zhongshan Hospital, Fudan University

ding.jing@zs-hospital.sh.cn+86 21 6404 1990

Outcome results

None listed

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