Clinical trial NCT06685601: An Intervention Study on Transcranial Photobiomodulation in Children with Attention Deficit Hyperactivity Disorder
Official title: An Intervention Study on Transcranial Photobiomodulation for Children with Attention-Deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ADHD - Attention Deficit Disorder with Hyperactivity
Keywords: tPBM
ADHD
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: Capital Medical University
name: Peking Union Medical College
name: Chinese Academy of Medical Sciences
First posted: 2024-11-12
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to intervene in children and adolescents with ADHD using transcranial photobiomodulation, comparing its effects on executive function at the levels of electroencephalography (EEG), eye tracking, and cognitive behavior. The goal is to identify the most effective clinical treatment strategy for ADHD patients.

Detailed description: This study is conducted as a randomized double-blind trial to investigate the effects of photobiomodulation therapy on ADHD. Initially, standardized assessment tools (physician ratings and parent self-reports) are employed to evaluate baseline clinical symptoms in ADHD patients who meet the inclusion and exclusion criteria. The experiment utilizes a within-subject design (within-subject factors: real versus sham stimulation), with each participant randomly assigned to receive two interventions-one real and one sham stimulation-administered in a counterbalanced order, with at least a one-week interval between the two sessions. Immediately following the intervention, standardized assessment tools are used to evaluate multidimensional clinical symptoms, and data related to executive function, including cognitive behavioral data, electroencephalographic data, and eye-tracking data, are collected. The intervention is carried out by trained technicians in accordance with the randomization results, while maintaining blinding for both clinical evaluators and participants.

Eligibility criteria: Inclusion Criteria:

1. Age between 6 and 18 years;
2. Clinically diagnosed with ADHD by a psychiatrist;
3. 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);
4. M.I.N.I. KID interview shows only ADHD, with no other comorbidities;
5. Able to cooperate with transcranial photobiomodulation.
6. 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 Criteria:

1. Diagnosis of other severe mental illnesses, such as schizophrenia or bipolar disorder;
2. 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.;
3. Presence of significant structural brain abnormalities on imaging studies;
4. Presence of severe neurological diseases with a clear family history or potential risk;
5. Presence of metal implants or a pacemaker, or holes or fractures in the skull;
6. 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;
7. Raven's Progressive Matrices IQ score \< 85.

Primary outcomes:
measure: EEG(Electroencephalogram)
timeFrame: From enrollment to the end of treatment at 3 weeks"
measure: Executive Function Task
timeFrame: From enrollment to the end of treatment at 3 weeks"
Secondary outcomes:
measure: Swanson, Nolan, and Pelham Version IV
timeFrame: From enrollment to the end of treatment at 3 weeks"
measure: Sleep Disturbances Scale for Children
timeFrame: From enrollment to the end of treatment at 3 weeks"
measure: Behavior Rating Inventory of Executive Function
timeFrame: From enrollment to the end of treatment at 3 weeks"
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References: