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Research on the rehabilitation of limb dysfunction in stroke patients using transcranial ultrasound modulation technology

Research on the rehabilitation of limb dysfunction in stroke patients using transcranial ultrasound modulation technology

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114687
Enrollment
Unknown
Registered
2025-12-16
Start date
2024-10-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Stroke

Interventions

Conventional treatment group:Exercise therapy, occupational therapy, physical factor therapy, and daily living activity training
TFUS intervention+conventional treatment group:The tFUS treatment uses a transcranial ultrasound therapy device (Beijing Ruao Medical Technology Co., Ltd., model: 880C) to stimulate the affected side
TMS intervention+conventional treatment group:TMS treatment uses a transcranial magnetic stimulation therapy device (Max company, model: TMS-100B), which acts on the primary motor cortex (M1) area of

Sponsors

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. 18 to 80 years old (including boundary values). 2. Meets the diagnostic criteria for stroke approved at the Fourth National Conference on Cerebrovascular Disease. 3. One hemisphere of the brain is affected, and the diagnosis is confirmed through head CT or MRI examination. 4. Vital signs are stable, consciousness is clear, and motor commands are acceptable. 5. The Brunstrom stage of the affected limb is stage I or above, and the muscle tone MAS grading is between grade 0 and grade 3. 6. Voluntarily participate in this study and sign an informed consent form. If the subject is unable to read and/or sign the informed consent form due to reasons such as lack of legal capacity, their guardian must act as a proxy for the informed process and sign the informed consent form. If the subject lacks the ability to read the informed consent form (such as illiterate subjects), a witness must witness the informed process and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of mental illness, intellectual disability, cerebrovascular disease, and organic brain disease before onset. 2. Cardiogenic cerebral infarction or extensive cerebral hemorrhage, transient ischemic stroke, and reversible stroke. 3. Patients with bilateral hemisphere injuries and those who have undergone cranial surgery other than minimally invasive thrombectomy after stroke onset. 4. Severe cardiovascular and pulmonary complications affect rehabilitation assessors and those with residual limb movement dysfunction from previous injuries. 5. Equipped with pacemakers, cochlear implants, or other metallic foreign objects in the body. 6. History of primary or secondary epilepsy. 7. Other vulnerable groups: critically ill patients, patients with cognitive impairment (MMSE score less than 23), pregnant women, etc.

Design outcomes

Primary

MeasureTime frame
Fugl Meyer Scale Evaluation;Near-infrared brain functional imaging assessment;

Secondary

MeasureTime frame
Functional magnetic resonance imaging assessment;Brunnstrom stages;Modified Barthel Index,MBI;

Countries

China

Contacts

Public ContactSong Haixin

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

haixin.song@zju.edu.cn+86 188 5712 7521

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 25, 2026