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NCT Number: NCT06477263

NeuroCytotron in the Treatment of Autism Spectrum Disorder

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

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NeuroCytonix México

San Pedro Garza García, Nuevo León, 66224, Mexico

Location status: Recruiting

Location contact

Alexia N Lozano Morantes, MD

SUB_INVESTIGATOR

Karen P Camarillo Cárdenas

CONTACT

[email protected]

+52 8135414706

Leonel A Cantú Martínez, MD

SUB_INVESTIGATOR

Lorenzo R Morales Mancias, MD

PRINCIPAL_INVESTIGATOR

Salvador Berrones García

CONTACT

[email protected]

+52 8135414706

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neurocytotron

Device

Neuronal regeneration treatment

Primary outcomes

  1. Changes in Autism Diagnostic Observation Schedule-Second Edition scale scores

    Time frame: Through study completion, an average of 1 year

    • Variables related to social communication, such as quality of social interaction, emotional reciprocity, and verbal and nonverbal communication.
    • Variables related to repetitive and stereotyped behavior, such as repetitive motor movements and restricted interests or behaviors.
    • Autism Diagnostic Observation Schedule-Second Edition total score as a global measure of Autism Spectrum Disorder symptoms.

    The Autism Diagnostic Observation Schedule-Second Edition scores range from 0 to 24, where higher scores indicate a greater severity of Autism Spectrum Disorder symptoms

  2. Changes in Adaptive Behavioral Assessment System scores

    Time frame: Through study completion, an average of 1 year

    • Variables related to adaptive skills in areas such as communication, daily living, personal autonomy and social skills.
    • Total adaptive skills scores to assess overall functioning in different adaptive domains.

    The Autism Diagnostic Observation Schedule-Second Edition scores range from 0 to 24, where higher scores indicate a greater severity of Autism Spectrum Disorder symptoms

    The Adaptive Behavioral Assessment System scores range from 40 to 160, where higher scores indicate better adaptive functioning

  3. Changes in Childhood Autism Rating Scale scores

    Time frame: Through study completion, an average of 1 year

    • Variables related to the severity of ASD symptoms, including aspects such as social relationship, communication, stereotyped behavior and eye contact.
    • Childhood Autism Rating Scale total score as a global measure of Autism Spectrum Disorder symptom severity.

    The Childhood Autism Rating Scale scores range from 15 to 60, where higher scores indicate a greater severity of autism symptoms

  4. Changes in Gilliam Autism Measurement Scale score

    Time frame: Through study completion, an average of 1 year

    • Variables related to the severity of ASD symptoms, including areas such as social interaction, communication, stereotyped behaviors, and restricted interests.
    • Specific subscales of the Gilliam Autism Measurement Scale that assess different dimensions of Autism Spectrum Disorder symptoms.

    The Gilliam Autism Measurement Scale scores range from 0 to 174, where higher scores indicate a greater severity of autism symptoms

  5. Withdrawal Rate

    Time frame: Through study completion, an average of 1 year

    • To assess the study withdrawal rate to NeuroCytotron treatment to determine the feasibility and acceptability of treatment by subjects and caregivers.

  6. Adherence to Treatment

    Time frame: Through study completion, an average of 1 year

    • To assess the adherence to NeuroCytotron treatment to determine the feasibility and acceptability of treatment by subjects and caregivers.

  7. Treatment Security

    Time frame: Through study completion, an average of 1 year

    • Record any treatment-related adverse events to assess the safety of NeuroCytotron in this subject population.

  8. Change in the number of seizures or epileptic seizures during the study period

    Time frame: Through study completion, an average of 1 year

    • Obtain information on the number of seizures (if any) before and after treatment.

  9. Neurophysiological changes: in functional activity and brain anatomy using Magnetic Resonance Imaging

    Time frame: Through study completion, an average of 1 year

    • Representative, visual, motor, basal ganglia and other modules
    • Total brain volume
    • Frontal and temporal lobe volume
    • Cortical thickness in the frontal lobe
    • Surface area and cortical gyrification and cerebrospinal fluid volume
    • Cerebellum volume
    • Volume of the corpus callosum
    • White matter, hippocampus, amygdala, thalamus, and basal ganglia

    The above describes one assessment where several anatomical regions are imaged via Magnetic Resonance Imaging - sequence T1

  10. Neurophysiological changes: in functional activity and brain anatomy using Diffusion Tensor Imaging

    Time frame: Through study completion, an average of 1 year

    • Diffusion Tensor Imaging data, as an increase in the values of the anisotropy fractions (AF)

  11. Neurophysiological changes: in functional activity and brain anatomy using Electroencephalogram

    Time frame: Through study completion, an average of 1 year

    • Brain activities during resting states.

Secondary outcomes

  1. Changes in comorbid symptoms

    Time frame: Through study completion, an average of 1 year

    Evaluate changes in comorbid symptoms commonly associated with Autism Spectrum Disorder

  2. Changes in sensory processing: hypersensitivity by percentile ranks

    Time frame: Through study completion, an average of 1 year

    Measurement of changes in sensory processing difficulties, including hypersensitivity, using standardized tools such as the sensory profile by means of Percentile ranks and classifications on the Sensory Profile 2, which will be administered at baseline (pre-treatment) and after 28 days of treatment (post-treatment).

    Percentile Ranks: Typical Performance: Scores between the 25th and 75th percentiles. Probable Difference: Scores between the 2nd and 25th percentiles or between the 75th and 98th percentiles. Definite Difference: Scores below the 2nd percentile or above the 98th percentile.

    The scores in each sensory domain and the overall sensory profile will be recorded and analyzed to determine changes in sensory processing difficulties.

  3. Changes in sensory processing: hypersensitivity by classification scores

    Time frame: Through study completion, an average of 1 year

    Measurement of changes in sensory processing difficulties, including hypersensitivity, using standardized tools such as the sensory profile by means of Percentile ranks and classifications on the Sensory Profile 2, which will be administered at baseline (pre-treatment) and after 28 days of treatment (post-treatment).

    Classification Scores: Typical Performance: Indicates that the child's sensory processing is within the expected range for their age. Probable Difference: Suggests that the child's sensory processing is somewhat different from peers, possibly affecting their daily life. Definite Difference: Indicates significant differences in sensory processing that are likely to impact daily functioning.

    The scores in each sensory domain and the overall sensory profile will be recorded and analyzed to determine changes in sensory processing difficulties.

  4. Changes in sensory processing: hyposensitivity by percentile ranks

    Time frame: Through study completion, an average of 1 year

    Measurement of changes in sensory processing difficulties, including hyposensitivity, using standardized tools such as the sensory profile by means of Percentile ranks and classifications on the Sensory Profile 2, which will be administered at baseline (pre-treatment) and after 28 days of treatment (post-treatment).

    Percentile Ranks: Typical Performance: Scores between the 25th and 75th percentiles. Probable Difference: Scores between the 2nd and 25th percentiles or between the 75th and 98th percentiles. Definite Difference: Scores below the 2nd percentile or above the 98th percentile.

    The scores in each sensory domain and the overall sensory profile will be recorded and analyzed to determine changes in sensory processing difficulties.

  5. Changes in sensory processing: hyposensitivity by classification scores

    Time frame: Through study completion, an average of 1 year

    Measurement of changes in sensory processing difficulties, including hyposensitivity, using standardized tools such as the sensory profile by means of Percentile ranks and classifications on the Sensory Profile 2, which will be administered at baseline (pre-treatment) and after 28 days of treatment (post-treatment).

    Classification Scores: Typical Performance: Indicates that the child's sensory processing is within the expected range for their age. Probable Difference: Suggests that the child's sensory processing is somewhat different from peers, possibly affecting their daily life. Definite Difference: Indicates significant differences in sensory processing that are likely to impact daily functioning.

    The scores in each sensory domain and the overall sensory profile will be recorded and analyzed to determine changes in sensory processing difficulties.

Study contacts

Contact information is provided by the study sponsor or research team.

Karen Camarillo Cardenas

CONTACT

[email protected]

+528135414706

Sponsors and collaborators

Lead sponsor

Neurocytonix, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2024
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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