NCT07276555

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

Not yet recruiting NA Last updated 16 December 2025

What this trial tests

NA trial testing Functional Neurogenesis Stimulation Therapy in Autism Spectrum Disorder in 256 participants. Not yet recruiting.

Timeline

1 February 2026

Primary endpoint
1 February 2029

29 May 2029

Quick facts

Lead sponsor	Neurocytonix, Inc.
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	256
Start date	1 February 2026
Primary completion	1 February 2029
Estimated completion	29 May 2029
Sites	2 locations across United States, Mexico

Drugs / interventions tested

• Functional Neurogenesis Stimulation Therapy
• placebo control group

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

Neurocytonix, Inc.

Who can join

Adults 3 to 12, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.