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Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder

NCT06006637 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-10-14

No results posted yet for this study

Summary

This study will consist of a randomized, double-blind, sham-controlled clinical trial at SUNY Upstate Medical University and Mt. Sinai Medical Center with 80 autistic children evaluating the effects of transcranial photobiomodulation (tPBM) on multiple clinically validated scales.

Conditions

Interventions

DEVICE

Cognilum TM: Light Treatment Condition

The children will wear the CognilumTM device for approximately 10 minutes at a time, twice a week, for a period of 10 weeks.

Sponsors & Collaborators

  • JelikaLite LLC

    collaborator INDUSTRY

  • Mt. Sinai School of Medicine, New York, New York

    collaborator UNKNOWN

  • MetroEHS

    collaborator UNKNOWN

  • State University of New York - Upstate Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-17
Primary Completion
2026-08-15
Completion
2026-08-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06006637 on ClinicalTrials.gov