Using NeuroCytotron to treat Autism Spectrum Disorder

Preliminary Efficacy and Feasibility of Using NeuroCytotron in the Treatment of Autism Spectrum Disorder: A Pilot Study

This study is testing a new treatment called NeuroCytotron to see if it can help improve symptoms and quality of life for people with Autism Spectrum Disorder, aged 3 to 50.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 3 Years to 50 Years
• Sex: All
• Sponsor: Neurocytonix, Inc. (Industry-sponsored)
• Locations: 1 site (San Pedro Garza García, Nuevo León)
• Trial ID: NCT06477263 on ClinicalTrials.gov

What this trial studies

This pilot study evaluates the effects of NeuroCytotron, a neuronal regeneration treatment, on symptoms of Autism Spectrum Disorder (ASD). It is an open-label, single-center trial that aims to collect preliminary data on safety and efficacy, determine appropriate dosing, and assess the impact on participants' quality of life over a 13-month period. The study includes subjects aged 3 to 50 years with a confirmed diagnosis of ASD and varying severity levels. Participants will undergo treatment sessions while being monitored for their health and stability.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 3 to 50 years with a confirmed diagnosis of Autism Spectrum Disorder and severity grades 1 to 3.

Not a fit: Patients with severe neurological disorders or uncontrolled epilepsy may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could improve symptoms and quality of life for individuals with Autism Spectrum Disorder.

How similar studies have performed: This approach is experimental and has not been widely tested in similar studies, making it a novel investigation.

Eligibility criteria

Inclusion Criteria:

1. Male or female subjects with a confirmed diagnosis of ASD according to DSM-5 criteria.
2. Subjects ≥ 3 and ≤ 50 years.
3. Subjects with ASD severity grade 1 to 3 according to DSM-5 criteria.
4. To have the informed consent of the parents or legal representatives for the subject's participation in the study.
5. Subjects must be physically able and willing to undergo the treatment sessions.
6. Subjects must be medically and psychologically stable to participate in the study.

Exclusion Criteria:

1. Presence of medical conditions that could contraindicate the use of NeuroCytotron DM, such as severe neurological disorders and difficult-to-control epilepsy.

   1. uncontrolled epilepsy is defined as: more than 1 generalized seizure in any month within the 3 months prior to the day 1 visit, or
   2. 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.
2. Concurrent participation in other therapies or interventions for autism during the study period.
3. Logistical or situational limitations that prevent regular attendance at treatment sessions.
4. History of significant adverse reactions to similar treatments or involving the use of anesthesia.
5. Presence of serious behavioral problems or aggression that may affect the safety of the subject or staff during treatment sessions.
6. Current or recent (previous 14 days) history of clinically significant bacterial, fungal, viral or mycobacterial infection.
7. Subjects with magnetic implants, pacemakers, claustrophobia or any other condition that prevents them from entering or remaining in the DM NeuroCytotron.

Where this trial is running

San Pedro Garza García, Nuevo León

• NeuroCytonix México — San Pedro Garza García, Nuevo León, Mexico (Recruiting)

Study contacts

• Principal investigator: Lorenzo R Morales Mancias — NeuroCytonix Mexico
• Study coordinator: Karen Camarillo Cardenas

Conditions Autism Spectrum Disorder