Spinal cord stimulation to treat hereditary spastic paraplegia

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900024243

Enrollment

Unknown

Registered

2019-07-02

Start date

2019-07-22

Completion date

Unknown

Last updated

2019-10-21

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

Conditions

hereditary spastic paraplegia

Interventions

1:spinal cord stimulation

Eligibility

Sex/Gender

All

Age

22 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Main manifestations: progressive lower limb weakness, hyperreflexia, Babinski sign, gait disturbance, with or without sphincter and autonomic dysfunction, with or without a positive family history; 2. Genetic analysis to confirm the diagnosis of hereditary spastic paraplegia; 3. Brain and spinal cord MRI to exclude cerebral palsy, multiple system atrophy, adrenoleukodystrophy, multiple sclerosis, primary lateral sclerosis, tumor, cerebrovascular disease, trauma and spastic paraplegia caused by structural abnormalities of the central nervous system; 4. Aged 22-65 years; 5. Diagnosed for more than one year, spastic paraplegia with progressing or no improvement after at least 6 months conservative treatment; 6. No use of botulinum toxin within 6 months, no use of baclofen or other muscle relaxers within 2 weeks; 7. Willing to undergo regular follow-up and related evaluation; 8. 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. Pregnancy; 5. Dementia, Parkinson's disease or epilepsy; 6. Coma; 7. Osteoporosis; 8. Depression; 9. Mechanical ventilation; 10. Active implanted cardiac pacemaker or defibrillator; 11. Paralysis of the lower limbs caused by spinal cord trauma; 12. Lower limb paraplegia after spinal spinal surgery.

Design outcomes

Primary

Measure	Time frame
Spastic Paraplegia Rating Scale (SPRS);spasticity;Electrophysiology;	—

Secondary

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

Countries

China

Contacts

Public ContactLiu Song

Beijing Tiantan Hospital, Capital Medical University

dr_songliu2018@163.com+86 13501343651

Outcome results

None listed

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