Status:
NOT_YET_RECRUITING
Transcranial Photobiomodulation With Multiple Interventions in Children With Attention-Deficit/Hyperactivity Disorder
Lead Sponsor:
Qilu Hospital of Shandong University
Conditions:
Attention Deficit Hyperactivity Disorder (ADHD)
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief Summary
To investigate the therapeutic efficacy of transcranial photobiomodulation (tPBM) with multiple interventions in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). The stud...
Eligibility Criteria
Inclusion
- Age between 6 and 18 years;
- Clinically diagnosed with ADHD by a psychiatrist;
- Confirmed by the researcher (child psychiatrist) to meet the diagnostic criteria for Attention-Deficit/Hyperactivity Disorder as outlined in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- M.I.N.I. KID interview shows only ADHD, with no other comorbidities;
- Able to cooperate with transcranial photobiomodulation.
- The participant and their guardian fully understand the study procedures and content and agree to participate in the study, signing the informed consent form.
Exclusion
- Diagnosis of other severe mental illnesses, such as schizophrenia or bipolar disorder;
- Presence of severe physical diseases or conditions, such as significant intracranial lesions, thyroid disorders, epilepsy, congenital heart disease, severe hematologic disorders, systemic lupus erythematosus, auditory or visual impairments, etc.;
- Presence of significant structural brain abnormalities on imaging studies;
- Presence of severe neurological diseases with a clear family history or potential risk;
- Presence of metal implants or a pacemaker, or holes or fractures in the skull;
- Currently undergoing other ADHD treatments (e.g., methylphenidate or other pharmacological treatments, behavioral therapy, etc.) or has discontinued such treatments for less than 2 weeks;
- Raven's Progressive Matrices IQ score \< 85.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2027
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT07154732
Start Date
October 1 2025
End Date
January 30 2027
Last Update
October 6 2025
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