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Preliminary Efficacy and Feasibility of Using NeuroCytotron in the Treatment of Autism Spectrum Disorder
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm One | Experimental | All participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurocytotron | Device | Neuronal regeneration treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Autism Diagnostic Observation Schedule-Second Edition scale scores |
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 |
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 |
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 |
The Gilliam Autism Measurement Scale scores range from 0 to 174, where higher scores indicate a greater severity of autism symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Presence of medical conditions that could contraindicate the use of NeuroCytotron DM, such as severe neurological disorders and difficult-to-control epilepsy.
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen Camarillo Cardenas | Contact | +528135414706 | kcamarillo@neurocytonix.com |
| Name | Affiliation | Role |
|---|---|---|
| J R Trujillo | jrtrujillo@neurocytonix.com | Study Chair |
| Lorenzo R Morales Mancias | NeuroCytonix Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NeuroCytonix México | Recruiting | San Pedro Garza García | Nuevo León | 66224 | Mexico |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| 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 |
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 |
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 |