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Clinical study on the influence of low-intensity focused ultrasound on the dorsolateral prefrontal cortex on behavioral phenotype in autism spectrum disorders

Clinical study on the influence of low-intensity focused ultrasound on the dorsolateral prefrontal cortex on behavioral phenotype in autism spectrum disorders

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096862
Enrollment
Unknown
Registered
2025-02-07
Start date
2024-08-19
Completion date
Unknown
Last updated
2025-02-10

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

Conditions

Autism Spectrum Disorder

Interventions

LIFUS group:Combined with LIFUS on the basis of routine rehabilitation therapy
control group:Give routine rehabilitation treatment

Sponsors

Shanghai Yangzhi rehabilitation hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 8 Years

Inclusion criteria

Inclusion criteria: 1. Age range 2 to 8 years old; 2. Meet the diagnostic criteria for ASD as defined in the newly revised fifth edition of the Diagnostic and Statistical Manual of Mental Disorders; 3. The patient's parents agree and sign the informed consent, and can cooperate with the treatment; 4. Childhood autism rating scale (CARS) score >=30 points; 5. Autism behavior check-list (ABC) score >=68 points; 6. Currently epilepsy free; 7. No history of serious neurological diseases or other psychiatric history; 8. No exposure to other neuroregulatory treatments within the last 30 days; 9. Suitable for MRI (no metal implants in the body); 10. No medication was taken during the study.

Exclusion criteria

Exclusion criteria: 1. Have a major physical illness that may pose a risk to life and health during the study period; 2. Combined with other serious neuropsychiatric diseases, or other developmental retardation problems resulting in inability to cooperate; 3. Contraindication of MRI (metal implants in the body); 4. The treatment site has damage, infection and other conditions; 5. Those who do not cooperate with treatment; 6. Other researchers judge that it is not suitable to participate in this researcher;

Design outcomes

Primary

MeasureTime frame
Childhood Autism Rating Scale;

Secondary

MeasureTime frame
Autism Behavior Checklist;Resting state EEG;

Countries

China

Contacts

Public ContactChaoshan Yan

Shanghai Yangzhi rehabilitation hospital

765341109@qq.com+86 21 37730011

Outcome results

None listed

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