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Analysis of the efficacy of a Brain-computer Interface device combined with the Early Start Denver Model on children with Autism Spectrum Disorder

Analysis of the efficacy of a Brain-computer Interface device combined with the Early Start Denver Model on children with Autism Spectrum Disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097717
Enrollment
Unknown
Registered
2025-02-25
Start date
2025-03-15
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Autism Spectrum Disorder

Interventions

Control group :Early Start Denver Model intervention
Intervention group:Brain-computer interface combined with Early Start Denver Mode intervention

Sponsors

Shanghai Rehabilitation Center for Special Children
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 6 Years

Inclusion criteria

Inclusion criteria: (1) Age: 3 to 6 years old; (2) children with ASD diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V); (3) Guardians agree to participate in the study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Those with other neurological diseases, such as epilepsy, attention deficit hyperactivity disorder, etc.; (2) Participants in other neurofeedback training intervention projects during the study period; (3) Those who are unable to understand and cooperate with the trial instructions and requirements.

Design outcomes

Primary

MeasureTime frame
The scores of six dimensions: cognitive processing, language expression, language comprehension, imitation, emotional expression, and social interaction in The Third Edition of the Revised Chinese Version of Psychoeducational Profile;

Secondary

MeasureTime frame
The scores of seven dimensions: fine motor skills, gross motor skills, non-verbal behavior characteristics, language behavior characteristics, problem behaviors, personal self-care, and adaptive behaviors in The Third Edition of the Revised Chinese Version of Psychoeducational Profile;Griffiths Mental Development Scale-Chinese;Mission state functional near-infrared spectroscopy imaging;

Countries

China

Contacts

Public ContactMin Shen/Yulan Guo

Shanghai Rehabilitation Center for Special Children/Shanghai University of Traditional Chinese Medicine

minshen223@qq.com+86 180 1888 0579

Outcome results

None listed

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