Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2025-12-17 @ 5:41 PM
Study NCT ID:
NCT06359080
Status:
None
Last Update Posted:
2024-06-06 00:00:00
First Post:
2024-04-02 00:00:00
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:
None
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 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.
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