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

Part of paid clinical trials in Rockville, Maryland.

Sponsor
Neurocytonix, Inc.
Study ID
NCT07276555
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
3 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Functional Neurogenesis Stimulation Therapy — DEVICE
    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.
  • placebo control group — OTHER
    This group will be placed on the device, but will not be treated (placebo group).

Study Details

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.

Key Dates

Start date
Feb 1, 2026
Status verified
Dec 2025
Primary completion
Feb 1, 2029
Completion
May 29, 2029

Study Design

Enrollment
256 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo Control Group
    Group not treated with Functional Neurogenesis Stimulation Therapy (NeuroCytotron)
  • Experimental: Functional Neurogenesis Stimulation Therapy Treatment Group
    Group treated with Functional Neurogenesis Stimulation Therapy (NeuroCytotron)

Primary Outcome Measure

Change in Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) total score [ Time Frame: Baseline (pre-treatment, Days -3 to -1) to 12 weeks after the end of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NeuroCytonix, Inc.RockvilleMaryland20850
Daniel R Trujillo, M.S.
[email protected]
240-243-6455

Find similar trials in Rockville, MD

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
NeuroCytonix, Inc.· Rockville, MD

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