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Spinal Cord Stimulation Therapy for Spastic Gait in Patients With Central Nervous System Diseases

Study for Spinal Cord Stimulation Therapy for Spastic Gait in Patients With Central Nervous System Diseases

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029161
Enrollment
Unknown
Registered
2020-01-17
Start date
2020-01-01
Completion date
Unknown
Last updated
2020-01-20

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

Conditions

Central Nervous System Diseases

Interventions

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Citizens of the People's Republic of China, aged between 18 and 60 years; 2. Causes of CNS injury; 3. The central nervous system injury is mainly manifested as spastic gait: when unilateral is involved, the lower limbs of the affected side straighten outwards and move forward in a circle, walking inwards, sagging toes, and often accompanied by Ipsilateral upper limb flexion and internal rotation. When both sides are involved, it is mainly stiff adduction of both lower limbs. When walking, the front and back crosses are scissors-like, and the toes are mopped. Physical examination of the nervous system is consistent with upper motor neuron injury, including increased muscle tone, hypertenoid reflexes, positive pathological signs, myoclonus, insignificant muscle atrophy, and no muscle fiber tremor; 4. The above items 2 and 3 are independently diagnosed by 2 dyskinesia specialists from the Department of Neurology, Ruijin Hospital; for patients whose diagnosis is in dispute, the professional team of Department of Neurology, Ruijin Hospital will make a collective decision; 5. Fully understand and sign informed consent for this study.

Exclusion criteria

Exclusion criteria: 1. Obvious mental symptoms or severe depression; 2. Patients with significant cognitive impairment (MMSE <20 points); 3. Severe loss of posture reflexes (inability to stand and walk independently), relying on a walker or wheelchair; 4. Rely on nasal feeding tubes for food; 5. Women of childbearing age who were pregnant at the time of enrollment; 6. Have a clear history of brain disease (clear history of stroke, history of traumatic brain injury, history of brain tumors, hydrocephalus); 7. Patients with severe heart, liver, kidney and other medical diseases; 8. Preoperative evaluation found to be unsuitable for spinal cord stimulation; 9. Other situations in which the researcher considers it inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
Three-dimentional gait analysis;

Secondary

MeasureTime frame
MRC muscle strength assessment;Modified Ashworth asticity scale;Clonus grading;Hoffer classification;Holden walking function scale;Tinetti scale;Rivermead moter assessment;

Countries

China

Contacts

Public ContactLi Cao

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

caoli2000@yeah.net+86 021 64457249

Outcome results

None listed

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