Recruiting NCT06477263
NeuroCytotron in the Treatment of Autism Spectrum Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neurocytotron.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder. Basic parameters: 3 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Preliminary Efficacy and Feasibility of Using NeuroCytotron in the Treatment of Autism Spectrum Disorder: A Pilot Study
Overview
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.
Interventions
- Device Neurocytotron
Neuronal regeneration treatment
Primary outcome measures
- Changes in Autism Diagnostic Observation Schedule-Second Edition scale scores [Time frame: Through study completion, an average of 1 year]
- Changes in Adaptive Behavioral Assessment System scores [Time frame: Through study completion, an average of 1 year]
- Changes in Childhood Autism Rating Scale scores [Time frame: Through study completion, an average of 1 year]
- Changes in Gilliam Autism Measurement Scale score [Time frame: Through study completion, an average of 1 year]
- Withdrawal Rate [Time frame: Through study completion, an average of 1 year]
- Adherence to Treatment [Time frame: Through study completion, an average of 1 year]
- Treatment Security [Time frame: Through study completion, an average of 1 year]
- Change in the number of seizures or epileptic seizures during the study period [Time frame: Through study completion, an average of 1 year]
- Neurophysiological changes: in functional activity and brain anatomy using Magnetic Resonance Imaging [Time frame: Through study completion, an average of 1 year]
- Neurophysiological changes: in functional activity and brain anatomy using Diffusion Tensor Imaging [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (5)
- Changes in comorbid symptoms [Time frame: Through study completion, an average of 1 year]
- Changes in sensory processing: hypersensitivity by percentile ranks [Time frame: Through study completion, an average of 1 year]
- Changes in sensory processing: hypersensitivity by classification scores [Time frame: Through study completion, an average of 1 year]
- Changes in sensory processing: hyposensitivity by percentile ranks [Time frame: Through study completion, an average of 1 year]
- Changes in sensory processing: hyposensitivity by classification scores [Time frame: Through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Mexico · 1 center
- NeuroCytonix México — San Pedro Garza García
Identifiers
NCT: NCT06477263 · NCX-ASD-01