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Transcranial Photobiomodulation (tPBM) Treatment for Minor Patients with Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo-Controlled Clinical Study

Transcranial Photobiomodulation (tPBM) Treatment for Minor Patients with Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo-Controlled Clinical Study

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105992
Enrollment
Unknown
Registered
2025-07-15
Start date
2025-07-20
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Autism Spectrum Disorder

Interventions

Active Stimulation Group:Transcranial Photobiomodulation Active Stimulation
Sham Stimulation Group:Transcranial Photobiomodulation Sham Stimulation

Sponsors

The Affiliated Brain Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Clinically confirmed ASD, if not yet diagnosed, the outpatient attending physician or above will make a clinical diagnosis according to the ASD diagnostic criteria of ICD-10 or DSM-5; 2. Age 3-12 years old; 3. Participants and/or their parents are required to sign a written informed consent form; 4. Right hand.

Exclusion criteria

Exclusion criteria: 1. The diagnosis of multiple doctors is inconsistent; 2. Contraindications to tPBM (such as head or scalp injury, photosensitivity disorder); 3. Coexisting with other psychiatric disorders that meet the diagnostic criteria for the disease, such as epilepsy, schizophrenia, bipolar disorder, attention deficit hyperactivity disorder, depression, tic disorder, etc.; 4. Unable to cooperate with the completion of phototherapy; 5. Have organic diseases of the brain, or the skin of the head is damaged or infected; 6. Those who have received other treatments within three months and are adjusting the treatment plan.

Design outcomes

Primary

MeasureTime frame
Social competence;Severity of autism symptoms;Language ability;Irritable mood issues;Severity of repetitive stereotyped behaviors;Level of Brain Activity;Brain wave patterns;

Secondary

MeasureTime frame
Severity of autism symptoms;Sleep Quality;Heart Rate Variability;

Countries

China

Contacts

Public ContactXiaoyan Ke

The Affiliated Brain Hospital of Nanjing Medical University

625213208@qq.com+86 181 1456 7850

Outcome results

None listed

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