Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Richard Frye
Age
4–16
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Safety and Efficacy of tPBM for Epileptiform Activity in Autism
