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

Prior treatment

• 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
• 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.

Other illness

• Presence of medical conditions that could contraindicate the use of NeuroCytotron,
• History of significant adverse reactions to similar treatments or involving the use of anesthesia.
• Participants diagnosed with ASD will be excluded from the protocol if they present any of the following conditions identified through imaging studies:
• Arteriovenous malformations or aneurysms with an immediate risk of rupture or bleeding.
• Active intracranial hemorrhage.
• Intracranial infections, abscesses, or any evidence of active inflammation seen in imaging studies.

Other

• study period and within the last 6 months.
• Logistical or situational limitations that prevent regular attendance at treatment
• sessions.
• Presence of serious behavioral problems or aggression that may affect the safety of the subject or staff during treatment sessions.
• Major Structural Lesions:
• Primary or metastatic brain tumors that compromise general neurological function.
• High-Risk Vascular Abnormalities:
• Evidence of Acute Neurological Damage:
• Recent cerebral infarction (\< 3 months).
• 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:

• 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.