Skip to content

Development and Clinical Validation of Brain Network-Guided Transcranial Focused Ultrasound Technologies for Post-Stroke Motor Dysfunction

Development and Clinical Validation of Brain Network-Guided Transcranial Focused Ultrasound Technologies for Post-Stroke Motor Dysfunction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123429
Enrollment
Unknown
Registered
2026-04-27
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Stroke

Interventions

Part I: healthy people group:None
Part I: stroke group:None
Part II: control group:Traditional Rehabilitation Therapy
Part II: intervention group 1:Traditional Rehabilitation Therapy+ultrasound stimulation protocol 1
Part II: intervention group 2:Traditional Rehabilitation Therapy+ultrasound stimulation protocol 2

Sponsors

Beijing Tiantan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria for the Healthy Control Group: 1. Age 18–80 years; 2. No motor dysfunction in the limbs; 3. No contraindications for MRI and able to cooperate with the MRI examination; 4. Signed informed consent form. Inclusion Criteria for the Patient Group: 1. Age 18–80 years; 2. Meets the Chinese Stroke Society/World Health Organization (WHO) criteria for stroke diagnosis, with imaging (CT or MRI) confirming a first episode of unilateral ischemic stroke; 3. Within 2 weeks to 3 months post-stroke; 4. Primary clinical presentation of hemiplegia, with a Brunnstrom score of >=3; 5. MRS <= 1 prior to onset; 6. No contraindications for MRI and able to cooperate with the MRI examination; 7. Signed informed consent form.

Exclusion criteria

Exclusion criteria: Part 1: Exclusion Criteria for Healthy Participants: 1. Concurrent neurological disorders (e.g., stroke, traumatic brain injury, epilepsy, neurodegenerative diseases); 2. Concurrent major medical conditions (e.g., cardiopulmonary dysfunction, renal insufficiency, etc.); 3. Concurrent cognitive impairment or psychiatric disorders; 4. Currently receiving medication that may affect neurological function (e.g., antipsychotics, antiepileptics, antidepressants, sedatives); 5. Concurrent diseases affecting the patient's motor function. Part 1: Exclusion Criteria for the Patient Group: 1. History of central nervous system diseases such as cerebral hemorrhage, traumatic brain injury, brain tumors, encephalitis, epilepsy, or Parkinson's disease; 2. Severe cognitive impairment, impaired consciousness, or aphasia, rendering the patient unable to cooperate with motor assessments; 3. Pre-existing unilateral motor dysfunction prior to onset; 4. Concurrent major medical conditions (e.g., cardiopulmonary dysfunction, renal insufficiency, etc.); 5. Seizures occurring after stroke; 6. Concurrent musculoskeletal disorders of the upper or lower limbs affecting the patient's motor function. Part II: Patient Group Exclusion Criteria: 1. History of central nervous system diseases such as cerebral hemorrhage, traumatic brain injury, brain tumors, encephalitis, epilepsy, or Parkinson's disease; 2. Severe cognitive impairment, impaired consciousness, or aphasia that prevents cooperation during motor assessment; 3. Pre-existing unilateral motor dysfunction prior to onset; 4. Concurrent major medical conditions (e.g., cardiopulmonary dysfunction, renal insufficiency, etc.); 5. Epileptic seizures occurring after stroke; 6. Concurrent musculoskeletal disorders of the upper or lower limbs that affect motor function; 7. Presence of intracranial implants (e.g., vascular stents, brain pacemakers); 8. Previous participation in any form of neuromodulation rehabilitation intervention.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Assessment;

Secondary

MeasureTime frame
Wolf Motor Function Test;Functional Ambulation Classification;Berg Balance Scale;Brunnstorm scale;Modified Rankin Scale;Modified Barthel Index;Hamilton Depression Scale;Hamilton Anxiety Scale;Stroke-specific Quality of Life Scale;head MRI;

Countries

China

Contacts

Public Contactzhang yumei

Beijing Tiantan Hospital, Capital Medical University

zhangyumei@aliyun.com+86 136 9140 4106

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026