NeuroCytotron in the Treatment of Autism Spectrum Disorder

NCT ID: NCT06477263

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2025-09-30

Brief Summary

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

Detailed 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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm One

All participants

Group Type: EXPERIMENTAL

Neurocytotron

Intervention Type: DEVICE

Neuronal regeneration treatment

Interventions

Neurocytotron

Neuronal regeneration treatment

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neurocytonix, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

J R Trujillo

Role: STUDY_CHAIR

jrtrujillo@neurocytonix.com

Lorenzo R Morales Mancias

Role: PRINCIPAL_INVESTIGATOR

NeuroCytonix Mexico

Locations

NeuroCytonix México

San Pedro Garza García, Nuevo León, Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Karen Camarillo Cardenas

Role: CONTACT

kcamarillo@neurocytonix.com

+528135414706

Facility Contacts

Karen P Camarillo Cárdenas

Role: primary

kcamarillo@neurocytonix.com

+52 8135414706

Salvador Berrones García

Role: backup

sberrones@neurocytonix.com

+52 8135414706

Other Identifiers

NCX-ASD-01

Identifier Type: -

Identifier Source: org_study_id