NeuroCytotron in the Treatment of Autism Spectrum Disorder

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство Neurocytotron
  Neuronal regeneration treatment

Первичные конечные точки

• Changes in Autism Diagnostic Observation Schedule-Second Edition scale scores [Срок оценки: Through study completion, an average of 1 year]
• Changes in Adaptive Behavioral Assessment System scores [Срок оценки: Through study completion, an average of 1 year]
• Changes in Childhood Autism Rating Scale scores [Срок оценки: Through study completion, an average of 1 year]
• Changes in Gilliam Autism Measurement Scale score [Срок оценки: Through study completion, an average of 1 year]
• Withdrawal Rate [Срок оценки: Through study completion, an average of 1 year]
• Adherence to Treatment [Срок оценки: Through study completion, an average of 1 year]
• Treatment Security [Срок оценки: Through study completion, an average of 1 year]
• Change in the number of seizures or epileptic seizures during the study period [Срок оценки: Through study completion, an average of 1 year]
• Neurophysiological changes: in functional activity and brain anatomy using Magnetic Resonance Imaging [Срок оценки: Through study completion, an average of 1 year]
• Neurophysiological changes: in functional activity and brain anatomy using Diffusion Tensor Imaging [Срок оценки: Through study completion, an average of 1 year]

Вторичные конечные точки (5)

• Changes in comorbid symptoms [Срок оценки: Through study completion, an average of 1 year]
• Changes in sensory processing: hypersensitivity by percentile ranks [Срок оценки: Through study completion, an average of 1 year]
• Changes in sensory processing: hypersensitivity by classification scores [Срок оценки: Through study completion, an average of 1 year]
• Changes in sensory processing: hyposensitivity by percentile ranks [Срок оценки: Through study completion, an average of 1 year]
• Changes in sensory processing: hyposensitivity by classification scores [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

• Male or female subjects with a confirmed diagnosis of ASD according to DSM-5 criteria.
• Subjects ≥ 3 and ≤ 50 years.
• Subjects with ASD severity grade 1 to 3 according to DSM-5 criteria.
• 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.

Критерии исключения

• Presence of medical conditions that could contraindicate the use of NeuroCytotron DM, 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 study period.
• Logistical or situational limitations that prevent regular attendance at treatment sessions.
• History of significant adverse reactions to similar treatments or involving the use of anesthesia.
• Presence of serious behavioral problems or aggression that may affect the safety of the subject or staff during treatment sessions.
• Current or recent (previous 14 days) history of clinically significant bacterial, fungal, viral or mycobacterial infection.
• Subjects with magnetic implants, pacemakers, claustrophobia or any other condition that prevents them from entering or remaining in the DM NeuroCytotron.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Мексика · 1 центр

• NeuroCytonix México — San Pedro Garza García

Идентификаторы

NCT: NCT06477263 · NCX-ASD-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗