Safety and Efficacy of tPBM for Epileptiform Activity in Autism

Epilepsy Clinical Trial

— tPBM  

Official title:

Safety and Efficacy of Transcranial Photobiomodulation (tPBM) for Individuals With Autism Spectrum Disorder and Epileptiform Activity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06352372
• Other study ID #: tPBM Study
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 2024
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Rossignol Medical Center
• Contact: Kelly Sirju
• Phone: 3212597111
• Email: kelly[@]rossignolmedicalcenter.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• EEG With Periodic Abnormalities
• Epilepsy
• Nervous System Diseases
• Neurodevelopmental Disorders
• Neurological Disorder

Intervention

Device:
• noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM)
The proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. 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.

Locations

Country	Name	City	State
United States	Rossignol Medical Center	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Richard Frye

Country where clinical trial is conducted

United States, 

References & Publications (43)

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* Note: There are 43 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Seizure frequency and severity	Seizure log will record the seizure severity and frequency	Baseline, Week 11 and Week 15 (One Month Follow-Up)
Other	Social Responsiveness Scale (SRS)	The SRS is a caregiver report of autism symptoms Lower Score is Better, Scores range from 30 to 90 (T-scores)	Baseline, Week 11 and Week 15 (One Month Follow-Up)
Other	Clinical Global Impression Scale (CGI)	The CGI measures the overall disease severity and change. It is completed by a clinician. Scores range from 1 to 7. Lower score is better	Baseline, Week 11 and Week 15 (One Month Follow-Up)
Other	NIH Toolbox	The NIH ToolBox is a set of short assessments for neurodevelopmental assessments. Direction of score depends on individual subtest.	Baseline, Week 11 and Week 15 (One Month Follow-Up)
Primary	Childhood Autism Rating Scores (CARS)	The CARS is a measure of autism severity completed by a clinician. Lower Score is Better. Scores range from 15 to 60.	Baseline, Week 11 and Week 15 (One Month Follow-Up)
Secondary	EEG Delta Power	Delta power is a measures of the amount of brain activity in the delta frequency as measured by overnight EEG	Before Treatment and EEG following treatment (within 6 months)