Clinical trial NCT06352372: Safety and Efficacy of tPBM for Epileptiform Activity in Autism
Official title: Safety and Efficacy of Transcranial Photobiomodulation (tPBM) for Individuals With Autism Spectrum Disorder and Epileptiform Activity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Autism Spectrum Disorder
EEG With Periodic Abnormalities
Epilepsy
Neurodevelopmental Disorders
Neurological Disorder
Keywords: Autism
Epilepsy
Neurological Disorders
Neurodevelopmental disorders
ASD
Lead sponsor: Rossignol Medical Center
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, open label study comparing 15 individuals with active seizures and 15 individuals with EEG abnormalities before and after treatment with, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM)
Primary purpose: TREATMENT

Brief summary: For this study, the proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. This will occur, twice a week, for 10 weeks. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills. Cognilum may impact the clinical practice of treating autism. At the beginning, at five weeks, and at the end of study, the clinician will complete the CARS-2, SRS, CGI, and a caregiver interview; additionally, questionnaires will be administered to caregivers during one of the 1-hour weekly treatment sessions.


Eligibility 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 \&lt; 5%ile or \&lt;5%ile for weight (male \&lt;11.2kg; female \&lt;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.

Primary outcomes:
measure: Childhood Autism Rating Scores (CARS)
timeFrame: Baseline, Week 11 and Week 15 (One Month Follow-Up)
Secondary outcomes:
measure: EEG Delta Power
timeFrame: Before Treatment and EEG following treatment (within 6 months)
Other outcomes:
measure: Seizure frequency and severity
timeFrame: Baseline, Week 11 and Week 15 (One Month Follow-Up)
measure: Social Responsiveness Scale (SRS)
timeFrame: Baseline, Week 11 and Week 15 (One Month Follow-Up)
measure: Clinical Global Impression Scale (CGI)
timeFrame: Baseline, Week 11 and Week 15 (One Month Follow-Up)
measure: NIH Toolbox
timeFrame: Baseline, Week 11 and Week 15 (One Month Follow-Up)
Locations:
city: Phoenix
country: United States
facility: Rossignol Medical Center
state: Arizona
Study officials:
affiliation: Rossignol Medical Center, Phoenix AZ
name: Richard E Frye, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
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