Phase
Condition
Essential Tremor
Tourette's Syndrome
Metachromatic Leukodystrophy - Mld
Treatment
noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM)
Clinical Study ID
Ages 4-12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Autism Spectrum Disorder (diagnosed as Autistic Disorder on the ADOS-2 or theADI-R).
Between 4 and 12 years of age, at baseline.
Autism severity of moderate or higher (≥4) under the 7-item clinical globalimpression-severity scale. Moderate level of autism severity (4) is defined by thediagnosis of ASD with language impairment.
Ability to maintain all ongoing complementary, dietary, traditional, and behavioraltreatments constant for the study period.
Unchanged complementary, dietary, traditional, and behavioral treatments for twomonths 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
Exclusion Criteria:
Significant self-abusive or violent behavior or evidence of suicidal ideation, planor behavior
Severely affected children as defined by CGI-Severity Standard Score = 7 (ExtremelyIll)
Severe prematurity (<34 weeks gestation) as determined by medical history
Current uncontrolled gastroesophageal reflux disease since GERD can cause movementsthat appear like seizures
Genetic syndromes
Congenital brain malformations
Any medical condition that the PI determines could jeopardize the safety of thestudy 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.
Study Design
Connect with a study center
Rossignol Medical Center
Phoenix, Arizona 85050
United StatesActive - Recruiting
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