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Spinal cord stimulation to treat spastic paraplegia after spinal cord injury

Spinal cord stimulation to treat spastic paraplegia after spinal cord injury

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024719
Enrollment
Unknown
Registered
2019-07-23
Start date
2019-07-29
Completion date
Unknown
Last updated
2019-07-29

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

Conditions

spinal cord injury

Interventions

Sponsors

Beijing Tiantan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 22-65 years; 2. Spastic paraplegia caused by traumatic spinal cord injury or after spinal surgery; 3. ASIA A, B, C or D Spinal Cord Injury Classification; 4. Brain and spinal cord MRI to exclude cerebral palsy, multiple system atrophy, adrenoleukodystrophy, multiple sclerosis, primary lateral sclerosis, tumor, cerebrovascular disease, traumatic brain injury and central nervous structural abnormalities; 5. Spinal cord injury between C6 and T10; 6. Spinal cord injury for more than one year, no improvement after at least 6 months conservative treatment; 7. No use of botulinum toxin within 6 months; 8. Willing to undergo regular follow-up and related evaluation; 9. Competence to decide to enroll and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe cardiopulmonary diseases or other serious diseases that are not suitable for surgery; 2. Unhealed fractures, severe muscle contracture, muscle pain, hemorrhoids or urinary tract infection that might interfere with postoperative rehabilitation; 3. Clinical significant psychiatric illnesses or substance abuse; 4. Dementia, Parkinson's disease or epilepsy; 5. Osteoporosis; 6. Pregnancy; 7. Mechanical ventilation; 8. Active implanted cardiac pacemaker or defibrillator; 9. Progressive worsening of spastic paraplegia after spinal cord injury; 10. Coma; 11. Pregnancy.

Design outcomes

Primary

MeasureTime frame
spasticity;Electrophysiology;Walking Index for Spinal Cord Injury (WISCI II);10-Meter Walk Test (10MWT);

Secondary

MeasureTime frame
Health Status Questionnaire (SF-36);Berg balance scale;Change in blood pre;Gait analysis;Neurogenic bowel dysfunction score;Neurogenic bladder symptom score;Visual Analogue Scal;sex function questionnaire;

Countries

China

Contacts

Public ContactLiu Song

Capital Medical University

dr_songliu2018@163.com+86 13501343651

Outcome results

None listed

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