Efficacy and Safety of Functional Neurogenesis Stimulation Therapy in Children With Autism Spectrum Disorder (ASD)

Summary

This study will test whether a noninvasive brain stimulation treatment called Functional Neurogenesis Stimulation (using the NeuroCytontron 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 may 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 utilizes low-energy electromagnetic fields, similar to those used in MRIs. 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.

Conditions

• Autism Spectrum Disorder

Interventions

DEVICE

Functional Neurogenesis Stimulation Therapy

NeuroCytotron is a noninvasive investigational medical device that delivers Functional Neurogenesis Stimulation using low-energy, pulsed electromagnetic fields to specific brain regions. For this study, each participant receives one 60-minute treatment session per day for 28 consecutive days. Treatment parameters (field strength, frequency, and beam geometry) are individualized for each child based on their baseline brain MRI to define a three-dimensional target volume. During each session, the child sits or lies comfortably inside the device while the pre-programmed treatment plan is delivered; no surgery, implants, or systemic medications are used.

OTHER

placebo control group

This group will be placed on the device, but will not be treated (placebo group).

Sponsors & Collaborators

• Neurocytonix, Inc.

  lead INDUSTRY

Principal Investigators

• Jose R Trujillo, M.D., Sc.D. · Neurocytonix, Inc.

• Lorenzo R Morales Mancias, M.D. · Neurocytonix, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-01

Primary Completion

2029-02-01

Completion

2029-05-29

FDA Device

Yes

Countries

• United States
• Mexico

Study Locations