Functional Neurogenesis Stimulation Therapy for Autism
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will test whether a noninvasive brain stimulation treatment called Functional Neurogenesis Stimulation (using the NeuroCytotron device) can safely improve core symptoms of autism spectrum disorder (ASD) in children. The study will enroll boys and girls 3 to 12 years old who have ASD (DSM-5 level 1-2) and use at least some spoken language. Children will be randomly assigned (like a coin flip) to receive either active NeuroCytotron sessions or sham (placebo) sessions that look the same but deliver no active treatment. Neither the families nor the study staff doing the assessments will know which treatment a child is receiving. The primary question is whether children who receive active treatment exhibit greater improvement in social communication, interaction, and repetitive behaviors compared to children who receive a placebo, as measured by standard autism rating scales. 
Each child's participation will last about 3 to 4 months, including screening, 28 days of daily, 1-hour treatment sessions, and follow-up visits up to 12 weeks after the last treatment. During the study, children will undergo physical exams, vital sign assessments, blood and urine tests, brain MRI scans, and electroencephalogram (EEG) recordings to examine brain structure and activity. Some children may need mild sedation or anesthesia for an MRI, which has its own risks. The device uses low-energy electromagnetic fields similar to those used in MRI. Possible risks include discomfort from lying still, anxiety around the device or MRI scanner, and side effects from sedation or from unexpected changes in behavior or seizures. There may or may not be direct benefit to each child, but information from this study may help researchers develop new, noninvasive treatment options for children with ASD in the future.
Who Is on the Research Team?
Jose R Trujillo, M.D., Sc.D.
Principal Investigator
Neurocytonix, Inc.
Lorenzo R Morales Mancias, M.D.
Principal Investigator
Neurocytonix, Inc.
Are You a Good Fit for This Trial?
This trial is for boys and girls aged 3 to 12 with Autism Spectrum Disorder (ASD) who can speak at least a little. They should be diagnosed as level 1-2 according to DSM-5 criteria. Children cannot participate if they have conditions that make the treatment unsafe or could interfere with the study results.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Functional Neurogenesis Stimulation Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Neurocytonix, Inc.
Lead Sponsor