Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359080
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2024-04-02
Brief Title:
Transcranial Photobiomodulation for Reducing Autism Symptoms in Children - Open Label Study TPBMASDOL
Sponsor:
JelikaLite LLC
Organization:
JelikaLite LLC
Study Overview
Official Title:
Transcranial Photobiomodulation for Reducing Autism Symptoms in Children
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The hypothesis of the study is that photobiomodulation reduces symptoms of autism Participants will be children between the ages of 2 and 7 who have been diagnosed with moderate to severe autism Transcranial photobiomodulation will be administered to the children in the experimental condition twice a week for 10 weeks Results will be measured through parental interviews standardized CARS2 Childhood Autism Rating Scales 2nd Edition and data collected from EEG
Detailed Description:
The CognilumTM System is a non-invasive device that uses infrared light IR delivered through light emitting diodes LEDs built into a head band worn by the patient during treatment
The proposed clinical investigation is determined by the FDA to be a nonsignificant risk NSR device study
The proposed clinical investigation is determined by the FDA to be a nonsignificant risk NSR device study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None