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Study on the mechanism of secondary excitability enhancement of non-affected motor cortex involved in post-stroke spasticity

Study on the mechanism of secondary excitability enhancement of non-affected motor cortex involved in post-stroke spasticity

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100048922
Enrollment
Unknown
Registered
2021-07-19
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-03-28

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

Conditions

Stroke

Interventions

Exposed group:Short-term intracortical inhibition of the non-involved motor cortex was greater than 1
Non-exposed group:Short-term intracortical inhibition of the non-involved motor cortex was less than or equal to 1

Sponsors

Jing'an District Centre Hospital of Shanghai, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. First onset, consistent with the diagnostic criteria of stroke at the 4th National Conference on Cerebrovascular Diseases in 1995, confirmed by cranial CT or MRI, and indicated unilateral subcortical lesions; 2. Right-handed, aged 18 to 90 years, weight not less than 40kg; 3. Course of disease: patients with post-stroke hemiplegia after acute stage, i.e., were enrolled on the 7th day after onset; 4. The presence of hemiplegia of one limb; 5. Subjects should receive standard physical/occupational therapy; 6. The subject's general condition and vital signs are stable, with normal level of consciousness and no visual or auditory impairment; 7. The MMSE score meets the following criteria: 17 in the illiteracy group (no education), 20 in the primary school group ( 6 years of education);According to the judgment of the researcher, the subject must clearly understand the purpose of the study, and be willing and able to comply with the requirements to complete the entire study; 8. Subjects have no previous history of brain injury, brain injury, stroke, intracranial tumor, other central nervous system diseases or surgical history of central nervous system surgery; 9. Subjects voluntarily participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Epilepsy patients; 2. The limb under study has severe contracture or lesions that interfere with the study; 3. Plan to perform phenol or alcohol block, cast, botulinum toxin to treat the spasticity of the upper extremity of the patient; 4. During this trial, new anticonvulsants are planned or expected to be used; 5. Patients who are pregnant, breastfeeding, pregnant during the planned trial, or women of childbearing age who do not take reliable contraceptive measures; 6. Patients with serious primary diseases such as heart, liver, kidney, hematopoietic system and endocrine system, and mental illness; 7. Those with poor compliance and unable to complete the test; 8. Patients with metallic foreign bodies (pacemakers, arterial stents, etc.); 9. There are contraindications to magnetic resonance examination.

Design outcomes

Primary

MeasureTime frame
Modified Ashworth scale;

Secondary

MeasureTime frame
Resistance to passive movement scale;Fugl-Meyer function assessment;Modified barthel index;Acoustic startle reflex;Sensory evoked potential;Motor evoked potential;Regions of interest activated voxel value;Lateralization indices;Fractional anisotropy;Functional links in brain regions;

Countries

China

Contacts

Public ContactWang Bei

Jing'an District Centre Hospital of Shanghai, Fudan University

drwangbei@163.com+86 13564902663

Outcome results

None listed

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