Autism Spectrum DisorderNCT07276555
Efficacy and Safety of Functional Neurogenesis Stimulation Therapy in Children With Autism Spectrum Disorder (ASD)
A study testing Functional Neurogenesis Stimulation Therapy in people with Autism Spectrum Disorder, run by Neurocytonix, Inc. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Functional Neurogenesis Stimulation Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Feb 2026to 29 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
NeuroCytonix, Inc.
Rockville, Maryland, 20850
Daniel R Trujillo, M.S., 240-243-6455, dtrujillo@neurocytonix.com
Mexico1 site
NeuroCytonix Mexico
San Pedro Garza García, Nuevo León, 66224
Lorenzo R Morales Macias, M.D., +52 81 3541 4706, lmorales@neurocytonix.com
Lorenzo R Morales Mancias, M.D.
About this study
Official title: Efficacy and Safety of Functional Neurogenesis Stimulation Therapy in Children With Autism Spectrum Disorder: A Multicenter, Randomized Controlled Trial
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
- Being tested
- Functional Neurogenesis Stimulation Therapy, placebo control group
- Keywords
- Neurocytotron, Autism Spectrum Disorder, ASD, Functional Neurogenesis Stimulation Therapy
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Neurogenesis Stimulation TherapyDevice
Also called NeuroCytotron
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 groupOther
This group will be placed on the device, but will not be treated (placebo group).
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control Group | Placebo comparator | Group not treated with Functional Neurogenesis Stimulation Therapy (NeuroCytotron) Receives: Other: placebo control group |
| Functional Neurogenesis Stimulation Therapy Treatment Group | Experimental | Group treated with Functional Neurogenesis Stimulation Therapy (NeuroCytotron) Receives: Device: Functional Neurogenesis Stimulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) total score
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.
Measured: Baseline (pre-treatment, Days -3 to -1) to 12 weeks after the end of treatment
Secondary outcomes (4)
Change in Childhood Autism Rating Scale, Third Edition (CARS-3) total score
The CARS-3 is a clinician-rated scale with 15 items that assess autism symptom severity based on direct observation. Each item is rated from 1 (within normal limits) to 4 (severely abnormal); total scores range from 15 to 60, with higher scores indicating more severe symptoms of autism. The secondary outcome will be the change in CARS-3 total score from baseline to 12 weeks post-treatment, comparing the NeuroCytotron and placebo groups. A decrease in score reflects improvement in autism severity.
Measured: Baseline (pre-treatment, Days -3 to -1) to 12 weeks after the end of treatment
Incidence and severity of treatment-emergent adverse events and serious adverse events
Adverse events (AEs) are any untoward medical occurrences in a participant, whether or not related to the investigational device. Serious adverse events (SAEs) include events that result in death, are life-threatening, require or prolong hospitalization, cause significant disability, or are otherwise medically significant. The outcome will summarize the number and percentage of participants with AEs, SAEs, and AEs leading to discontinuation in each group, as well as severity and relationship to study treatment, and overall tolerability based on caregiver/participant reports collected at each visit.
Measured: From first treatment session (Day 1) through 12-week follow-up (approximately 14 weeks total per participant)
Change in Gilliam Autism Rating Scale, Third Edition (GARS-3) total score
GARS-3 is a standardized rating scale used to identify and assess autism in individuals aged 3 to 22 years. It includes subscales for Social Interaction, Communication, and Stereotyped Behaviors, which contribute to a total score; higher scores indicate a greater likelihood or severity of autism. The secondary outcome is the change in GARS-3 total score from baseline to 12 weeks post-treatment, with lower scores indicating reduced autism-related behaviors, compared between treatment groups.
Measured: Baseline to 12 weeks after the end of treatment
Change in Adaptive Behavior Assessment System, Third Edition (ABAS-3) composite score
ABAS-3 is a caregiver- or teacher-completed questionnaire that evaluates adaptive functioning across multiple domains (communication, community use, functional academics, home living, health and safety, leisure, self-care, self-direction, social, and work). Higher scores indicate better adaptive functioning. The secondary outcome will be the change in ABAS-3 composite score from baseline to 12 weeks post-treatment, with higher post-treatment scores reflecting improvement, compared between treatment groups.
Measured: Baseline to 12 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion29 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurocytonix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose R Trujillo, M.D., Sc.D., Study chair, Neurocytonix, Inc.Lorenzo R Morales Mancias, M.D., Principal investigator, Neurocytonix, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276555
- Sponsor's protocol ID
- NCX-ASD-02
- Status last verified
- Dec 2025
- First submitted
- 29 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Functional Neurogenesis Stimulation Therapy in Children With Autism Spectrum Disorder: A Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07276555
- Acronym / sponsor ID
- NCX-ASD-02
- Conditions
- Autism Spectrum Disorder
- Keywords
- Neurocytotron, Autism Spectrum Disorder, ASD, Functional Neurogenesis Stimulation Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Neurocytonix, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 29 May 2029 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Control Group | Placebo comparator | Other: placebo control groupGroup not treated with Functional Neurogenesis Stimulation Therapy (NeuroCytotron) |
| Functional Neurogenesis Stimulation Therapy Treatment Group | Experimental | Device: Functional Neurogenesis Stimulation TherapyGroup treated with Functional Neurogenesis Stimulation Therapy (NeuroCytotron) |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (25 listed)
- Presence of medical conditions that could contraindicate the use of NeuroCytotron,
- such as severe neurological disorders and difficult-to-control epilepsy.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Neurogenesis Stimulation TherapyAlso: NeuroCytotronNeuroCytotron 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. | Device | Functional Neurogenesis Stimulation Therapy Treatment Group |
| placebo control groupThis group will be placed on the device, but will not be treated (placebo group). | Other | Placebo Control Group |
Primary outcome
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
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.
4 secondary outcomes
Change in Childhood Autism Rating Scale, Third Edition (CARS-3) total score
Time frame: Baseline (pre-treatment, Days -3 to -1) to 12 weeks after the end of treatment
Incidence and severity of treatment-emergent adverse events and serious adverse events
Time frame: From first treatment session (Day 1) through 12-week follow-up (approximately 14 weeks total per participant)
Change in Gilliam Autism Rating Scale, Third Edition (GARS-3) total score
Time frame: Baseline to 12 weeks after the end of treatment
Change in Adaptive Behavior Assessment System, Third Edition (ABAS-3) composite score
Time frame: Baseline to 12 weeks after the end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jose R Trujillo, M.D., Sc.D. study chair
Neurocytonix, Inc.
Lorenzo R Morales Mancias, M.D. principal investigator
Neurocytonix, Inc.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Neurogenesis Stimulation Therapy in people with Autism Spectrum Disorder, run by Neurocytonix, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose R Trujillo, M.D., Sc.D. (240-243-6455, jrtrujillo@neurocytonix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.