Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352372
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-03-22
Brief Title:
Safety and Efficacy of tPBM for Epileptiform Activity in Autism
Sponsor:
Richard Frye
Organization:
Rossignol Medical Center
Study Overview
Official Title:
Safety and Efficacy of Transcranial Photobiomodulation tPBM for Individuals With Autism Spectrum Disorder and Epileptiform Activity
Status:
RECRUITING
Status Verified Date:
2024-07
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:
tPBM
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
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None