NeuroCytotron in the Treatment of Autism Spectrum Disorder
NCT Number: NCT06477263
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autism Spectrum Disorder
Interventions: DEVICE: Neurocytotron
Sponsor: Neurocytonix, Inc.
Sex: ALL
Age: CHILD, ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2025-07-30
Locations: NeuroCytonix México, San Pedro Garza Garcia, Nuevo León, 66224, Mexico

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

Primary Outcome Measures: Changes in Autism Diagnostic Observation Schedule-Second Edition scale scores, * 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, Through study completion, an average of 1 year|Changes in Adaptive Behavioral Assessment System scores, * 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, Through study completion, an average of 1 year|Changes in Childhood Autism Rating Scale scores, * 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, Through study completion, an average of 1 year|Changes in Gilliam Autism Measurement Scale score, * 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, Through study completion, an average of 1 year|Withdrawal Rate, • To assess the study withdrawal rate to NeuroCytotron treatment to determine the feasibility and acceptability of treatment by subjects and caregivers., Through study completion, an average of 1 year|Adherence to Treatment, • To assess the adherence to NeuroCytotron treatment to determine the feasibility and acceptability of treatment by subjects and caregivers., Through study completion, an average of 1 year|Treatment Security, • Record any treatment-related adverse events to assess the safety of NeuroCytotron in this subject population., Through study completion, an average of 1 year|Change in the number of seizures or epileptic seizures during the study period, • Obtain information on the number of seizures (if any) before and after treatment., Through study completion, an average of 1 year|Neurophysiological changes: in functional activity and brain anatomy using Magnetic Resonance Imaging, * 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, Through study completion, an average of 1 year|Neurophysiological changes: in functional activity and brain anatomy using Diffusion Tensor Imaging, • Diffusion Tensor Imaging data, as an increase in the values of the anisotropy fractions (AF), Through study completion, an average of 1 year|Neurophysiological changes: in functional activity and brain anatomy using Electroencephalogram, • Brain activities during resting states., Through study completion, an average of 1 year
Secondary Outcome Measures: Changes in comorbid symptoms, Evaluate changes in comorbid symptoms commonly associated with Autism Spectrum Disorder, Through study completion, an average of 1 year|Changes in sensory processing: hypersensitivity by percentile ranks, 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., Through study completion, an average of 1 year|Changes in sensory processing: hypersensitivity by classification scores, 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., Through study completion, an average of 1 year|Changes in sensory processing: hyposensitivity by percentile ranks, 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., Through study completion, an average of 1 year|Changes in sensory processing: hyposensitivity by classification scores, 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., Through study completion, an average of 1 year