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

NCT ID: NCT07276555

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2029-05-29

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo Control Group

Group not treated with Functional Neurogenesis Stimulation Therapy (NeuroCytotron)

Group Type: PLACEBO_COMPARATOR

placebo control group

Intervention Type: OTHER

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

Functional Neurogenesis Stimulation Therapy Treatment Group

Group treated with Functional Neurogenesis Stimulation Therapy (NeuroCytotron)

Group Type: EXPERIMENTAL

Functional Neurogenesis Stimulation Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

placebo control group

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

Intervention Type: OTHER

Other Intervention Names

NeuroCytotron

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neurocytonix, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose R Trujillo, M.D., Sc.D.

Role: STUDY_CHAIR

Neurocytonix, Inc.

Lorenzo R Morales Mancias, M.D.

Role: PRINCIPAL_INVESTIGATOR

Neurocytonix, Inc.

Locations

NeuroCytonix, Inc.

Rockville, Maryland, United States

NeuroCytonix Mexico

San Pedro Garza García, Nuevo León, Mexico

Countries

United States; Mexico

Central Contacts

Jose R Trujillo, M.D., Sc.D.

Role: CONTACT

jrtrujillo@neurocytonix.com

240-243-6455

Karen P Camarillo Cardenas

Role: CONTACT

kcamarillo@neurocytonix.com

+52 81 3541 4706

Facility Contacts

Daniel R Trujillo, M.S.

Role: primary

dtrujillo@neurocytonix.com

240-243-6455

Lorenzo R Morales Macias, M.D.

Role: primary

lmorales@neurocytonix.com

+52 81 3541 4706

Other Identifiers

NCX-ASD-02

Identifier Type: -

Identifier Source: org_study_id