Using light therapy to improve symptoms of autism in children
Safety and Efficacy of Transcranial Photobiomodulation (tPBM) for Individuals With Autism Spectrum Disorder and Epileptiform Activity
This study is testing if a new light therapy can help improve focus, eye contact, speech, and behavior in children with autism aged 4 to 12.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 4 Years to 12 Years |
| Sex | All |
| Sponsor | Rossignol Medical Center Academic / other |
| Locations | 1 site (Phoenix, Arizona) |
| Trial ID | NCT06352372 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of transcranial Photobiomodulation (tPBM), a noninvasive treatment using near-infrared light, to address symptoms associated with Autism Spectrum Disorder (ASD) in children aged 4 to 12. Participants will receive treatment twice a week for 10 weeks using a wearable device called Cognilum, which targets specific brain areas. The study aims to assess improvements in focus, eye contact, speech, behavior, and functional skills through various clinical assessments and caregiver questionnaires. The outcomes may provide insights into new therapeutic approaches for managing autism.
Who should consider this trial
Good fit: Ideal candidates are children aged 4 to 12 diagnosed with moderate to severe Autism Spectrum Disorder.
Not a fit: Patients exhibiting severe self-abusive or violent behavior, or those classified as extremely ill, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to significant improvements in the quality of life for children with autism by enhancing their communication and social skills.
How similar studies have performed: While the use of light therapy in neurological disorders is an emerging field, this specific approach has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Autism Spectrum Disorder (diagnosed as Autistic Disorder on the ADOS-2 or the ADI-R). * Between 4 and 12 years of age, at baseline. * Autism severity of moderate or higher (≥4) under the 7-item clinical global impression-severity scale. Moderate level of autism severity (4) is defined by the diagnosis of ASD with language impairment. * Ability to maintain all ongoing complementary, dietary, traditional, and behavioral treatments constant for the study period. * Unchanged complementary, dietary, traditional, and behavioral treatments for two months prior to study entry * Ability to tolerate procedures, as determined at the discretion of the investigator. * At least one 24hr EEG with data in EDF format that is accessible to investigators. Exclusion Criteria: * Significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior * Severely affected children as defined by CGI-Severity Standard Score = 7 (Extremely Ill) * Severe prematurity (\<34 weeks gestation) as determined by medical history * Current uncontrolled gastroesophageal reflux disease since GERD can cause movements that appear like seizures * Genetic syndromes * Congenital brain malformations * Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data. * Failure to thrive or Body Mass Index \< 5%ile or \<5%ile for weight (male \<11.2kg; female \<10.8kg by CDC 2000 growth charts) at the time of the study. * Concurrent treatment with drug that would significantly interact with treatment. * • Stimulants * • Anti-Psychotics * • Antihistamines * Excessive Hair that the caregivers are unwilling or unable to shave or braid. * Inability to tolerate the required dosage of tPBM treatment due to sensory issues.
Where this trial is running
Phoenix, Arizona
- Rossignol Medical Center — Phoenix, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Richard E Frye, M.D., Ph.D — Rossignol Medical Center, Phoenix AZ
- Study coordinator: Kelly Sirju
- Email: kelly@rossignolmedicalcenter.com
- Phone: 3212597111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.