NeuroCytotron in the Treatment of Autism Spectrum Disorder

NeuroCytonix

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Device: Neurocytotron

Study type: Interventional

Funder types: Industry

Identifiers

NCT06477263

NCX-ASD-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 3 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Arm One

Experimental group

Description:

All participants

Treatment:

Device: Neurocytotron