Safety and Efficacy of tPBM for Epileptiform Activity in Autism

Korábbi kezelés

• Concurrent treatment with drug that would significantly interact with treatment.
  • • Stimulants
  • • Anti-Psychotics
  • • Antihistamines

Más betegség

• Current uncontrolled gastroesophageal reflux disease since GERD can cause movements that appear like seizures
• Genetic syndromes
• 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.

Egyéb

• 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
• Congenital brain malformations
• 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.

• 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.