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Functional Neurogenesis Stimulation Therapy for Children with Autism Spectrum Disorder

This study is looking at whether a non-invasive brain stimulation treatment called Functional Neurogenesis Stimulation Therapy (using the NeuroCytotron device) can safely improve key symptoms of Autism Spectrum Disorder (ASD) in children. We are enrolling boys and girls aged 3 to 12 years old who have been diagnosed with ASD (DSM-5 level 1 or 2) and use some spoken language. The study aims to see if this treatment can reduce ASD symptoms, measured by changes in the ADOS-2 (Autism Diagnostic Observation Schedule, Second Edition) score. This study is currently recruiting 256 participants.

Study design
This is an interventional study where children will be randomly assigned (like a coin flip) to receive either the active NeuroCytotron treatment or a placebo (sham) treatment. Neither the families nor the study staff will know which treatment a child is receiving.
What's involved
Participants will receive one 60-minute treatment session per day for 28 consecutive days. Assessments will be done before treatment and 12 weeks after the end of treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 weeks after the end of treatment to measure changes in their ADOS-2 score.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07276555

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

Not Yet Recruiting
NAAges 3–12InterventionalTreatment
Neurocytonix, Inc.
~256 participants
Updated 2025-12-16 on ClinicalTrials.gov
What's tested:Functional Neurogenesis Stimulation Therapyplacebo control group

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) total score
Measured over Baseline (pre-treatment, Days -3 to -1) to 12 weeks after the end of treatment

Conditions

Autism Spectrum Disorder

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NCT07276555

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • NeuroCytonix Mexico

    San Pedro Garza García, Nuevo León, Mexicostudy coordinator listed

  • NeuroCytonix, Inc.

    Rockville, Marylandstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jose R Trujillo, M.D., Sc.D. · STUDY_CHAIR · Neurocytonix, Inc.
  • Lorenzo R Morales Mancias, M.D. · PRINCIPAL_INVESTIGATOR · Neurocytonix, Inc.

Who to contact

Jose R Trujillo, M.D., Sc.D.
[email protected]
240-243-6455
Email the study team

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Eligibility criteria

Inclusion

Male or female subjects with a confirmed diagnosis of ASD according to DSM-5
criteria.
Subjects ≥ 3 and ≤ 12 years.
Subjects with ASD severity grade 1 to 2 according to DSM-5 criteria.
Participants must have functional use of language (i.e., at least some verbal
communication) to ensure that they engage with the assessments.
Stable on current medications for at least 4 weeks prior to the study.
To have the informed consent of the parents or legal representatives for the subject's
participation in the study.
Subjects must be physically able and willing to undergo the treatment sessions.
Subjects must be medically and psychologically stable to participate in the study.

Exclusion

Presence of medical conditions that could contraindicate the use of NeuroCytotron,
such as severe neurological disorders and difficult-to-control epilepsy.
uncontrolled epilepsy is defined as: more than 1 generalized seizure in any month within the 3 months prior to the day 1 visit, or
history of any of the following within 9 months prior to the day 1 visit: prolonged seizures or repetitive seizure activity requiring administration of a rescue benzodiazepine (oral, rectal, etc.) more than once a month, seizures lasting more than 10 minutes, status epilepticus or epilepsy with autonomic involvement.
Concurrent participation in other therapies or interventions for autism during the
study period and within the last 6 months.
Logistical or situational limitations that prevent regular attendance at treatment
sessions.
History of significant adverse reactions to similar treatments or involving the use of anesthesia.
Presence of serious behavioral problems or aggression that may affect the safety of the subject or staff during treatment sessions.
Current or recent (previous 14 days) history of clinically significant bacterial, fungal, viral or mycobacterial infection.
Presence of implanted medical devices or metallic foreign bodies that are not compatible with magnetic resonance imaging (MRI) or with the NeuroCytotron device, including but not limited to pacemakers, cochlear implants, deep brain stimulators, spinal cord stimulators, or any ferromagnetic implants.
Participants diagnosed with ASD will be excluded from the protocol if they present any of the following conditions identified through imaging studies:
Major Structural Lesions:
Primary or metastatic brain tumors that compromise general neurological function.
High-Risk Vascular Abnormalities:
Arteriovenous malformations or aneurysms with an immediate risk of rupture or bleeding.
Evidence of Acute Neurological Damage:
Recent cerebral infarction (\< 3 months).
Active intracranial hemorrhage.
Pathologies Interfering with Outcome Assessment:
Severe cerebral atrophy that significantly impacts the likelihood of response to treatment.
Severe congenital brain anomalies unrelated to the primary diagnosis of autism.
Active Pathologies Incompatible with the Protocol:
Intracranial infections, abscesses, or any evidence of active inflammation seen in imaging studies.

What this trial measures

  • Change in Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) total scoreBaseline (pre-treatment, Days -3 to -1) to 12 weeks after the end of treatment

    ADOS-2 is a standardized, semi-structured assessment that measures social communication, interaction, play, and restricted or repetitive behaviors in individuals with autism spectrum disorder. Higher total scores indicate greater severity of ASD symptoms. The primary outcome is the change in ADOS-2 total score from baseline to 12 weeks post-treatment, comparing participants treated with NeuroCytotron functional neurogenesis stimulation therapy to those treated with placebo. A decrease in score reflects improvement in core ASD symptoms.