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An Exploratory Clinical Study on the Effects of Low-Intensity Focused Ultrasound Targeting the Cerebellar Dentate Nucleus on Upper Limb Motor Function Following Ischemic Stroke

An Exploratory Clinical Study on the Effects of Low-Intensity Focused Ultrasound Targeting the Cerebellar Dentate Nucleus on Upper Limb Motor Function Following Ischemic Stroke

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126841
Enrollment
Unknown
Registered
2026-06-17
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

stroke

Interventions

Intervention Group:Low-intensity focused ultrasound stimulates the cerebellum to observe changes in patients' upper limb motor function

Sponsors

Xuanwu Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Participants aged >=18 years and =3 months. 4. Unilateral infarction within the anterior circulation territory, confirmed by CT or MRI. 5. Patients who have received reperfusion therapy, regardless of treatment modality. 6. Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) score <=42. 7. Right-handedness confirmed by the Edinburgh Handedness Inventory. 8. Participants who have adequate comprehension and communication abilities, voluntarily agree to participate in the study, and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. History of stroke; 2. Severe cognitive impairment or psychiatric symptoms; 3. Presence of other investigational devices or medications currently in use; 4. Bilateral brain lesions or concomitant neurological disorders (e.g., Parkinson’s disease, epilepsy, tumors); 5. Presence of cranial defects; 6. Elevated intracranial pressure; 7. Contraindications to MRI, such as the presence of metal inside or outside the skull, or the presence of implanted devices such as pacemakers or drug pumps; 8. Presence of other comorbidities, such as a history of severe failure of vital organs including the heart, lungs, liver, or kidneys; 9. Individuals unable to complete the full course of treatment, those with adverse reactions to stimulation, or those with poor compliance; 10. Individuals who have undergone similar interventions within the past 6 months or are currently participating in other clinical trials; 11. Pregnant or breastfeeding women, and patients unable to use appropriate contraceptive measures during the trial.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer motor function assessment;

Secondary

MeasureTime frame
Fugl-Meyer motor function assessment;Action Research Arm Test (ARAT);modified Rankin Scale (mRS);National Institutes of Health Stroke Scale (NIHSS);the Hamilton Anxiety Rating Scale (HAMA) and the Hamilton Depression Rating Scale (HAMD);multimodal magnetic resonance imaging (MRI);electroencephalography;transcranial magnetic stimulation;

Countries

China

Contacts

Public ContactJiao Liqun

Xuanwu Hospital, Capital Medical University

liqunjiao@sina.cn+86 139 1122 4991

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 29, 2026