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

Official title

Efficacy and Safety of Functional Neurogenesis Stimulation Therapy in Children With Autism Spectrum Disorder: A Multicenter, Randomized Controlled Trial

Overview

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.

Interventions

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

Primary outcome measures

• 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]

Secondary outcome measures (4)

• 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• NeuroCytonix, Inc. — Rockville

Mexico · 1 center

• NeuroCytonix Mexico — San Pedro Garza García

Identifiers

NCT: NCT07276555 · NCX-ASD-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗