NeuroCytotron in the Treatment of Autism Spectrum Disorder

Last updated: February 4, 2025
Sponsor: Neurocytonix, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Autism

Williams Syndrome

Asperger's Disorder

Treatment

Neurocytotron

Clinical Study ID

NCT06477263
NCX-ASD-01
  • Ages 3-50
  • All Genders

Study Summary

Preliminary Efficacy and Feasibility of Using NeuroCytotron in the Treatment of Autism Spectrum Disorder

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female subjects with a confirmed diagnosis of ASD according to DSM-5criteria.

  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 thesubject'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

Exclusion Criteria:

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

  2. uncontrolled epilepsy is defined as: more than 1 generalized seizure in anymonth within the 3 months prior to the day 1 visit, or

  3. history of any of the following within 9 months prior to the day 1 visit:prolonged seizures or repetitive seizure activity requiring administration of arescue benzodiazepine (oral, rectal, etc.) more than once a month, seizureslasting more than 10 minutes, status epilepticus or epilepsy with autonomicinvolvement.

  4. Concurrent participation in other therapies or interventions for autism during thestudy period.

  5. Logistical or situational limitations that prevent regular attendance at treatmentsessions.

  6. History of significant adverse reactions to similar treatments or involving the useof anesthesia.

  7. Presence of serious behavioral problems or aggression that may affect the safety ofthe subject or staff during treatment sessions.

  8. Current or recent (previous 14 days) history of clinically significant bacterial,fungal, viral or mycobacterial infection.

  9. Subjects with magnetic implants, pacemakers, claustrophobia or any other conditionthat prevents them from entering or remaining in the DM NeuroCytotron.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Neurocytotron
Phase:
Study Start date:
July 15, 2024
Estimated Completion Date:
September 30, 2025

Study Description

Experimental, pilot, one-arm, open-label, single-center, 13-month, single-center study to evaluate the effect of NCX neuronal regeneration treatment in subjects with Autism Spectrum Disorder (ASD) to explore the therapeutic effects of NeuroCytonix neuronal regeneration technology on ASD symptoms. Specific objectives include collecting preliminary safety and efficacy data, assessing appropriate dosing, and measuring the impact on participants' quality of life after treatment.

Connect with a study center

  • NeuroCytonix México

    San Pedro Garza Garcia, Nuevo León 66224
    Mexico

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.