Autism Spectrum DisorderNCT06477263
NeuroCytotron in the Treatment of Autism Spectrum Disorder
A study testing Neurocytotron in people with Autism Spectrum Disorder, run by Neurocytonix, Inc. at 1 site in Mexico.
Trial summary
Preliminary Efficacy and Feasibility of Using NeuroCytotron in the Treatment of Autism Spectrum Disorder Read more about this study
- Who is it for?
- Ages 3 to 50 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Neurocytotron
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- 15 Jul 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
NeuroCytonix México
San Pedro Garza García, Nuevo León, 66224
Karen P Camarillo Cárdenas, +52 8135414706, kcamarillo@neurocytonix.com
Salvador Berrones García, +52 8135414706, sberrones@neurocytonix.com
About this study
Official title: Preliminary Efficacy and Feasibility of Using NeuroCytotron in the Treatment of Autism Spectrum Disorder: A Pilot Study
Preliminary Efficacy and Feasibility of Using NeuroCytotron in the Treatment of Autism Spectrum Disorder
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Neurocytotron
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurocytotronDevice
Neuronal regeneration treatment
| Study group | Role | What they receive |
|---|---|---|
| Arm One | Experimental | All participants Receives: Device: Neurocytotron |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: Through study completion, an average of 1 year
Neurophysiological changes: in functional activity and brain anatomy using Electroencephalogram
- Brain activities during resting states.
Measured: Through study completion, an average of 1 year
Secondary outcomes (5)
Changes in comorbid symptoms
Evaluate changes in comorbid symptoms commonly associated with Autism Spectrum Disorder
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start15 Jul 2024
- Primary completion6 Mar 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurocytonix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J R Trujillo, Study chair, jrtrujillo@neurocytonix.comLorenzo R Morales Mancias, Principal investigator, NeuroCytonix Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477263
- Sponsor's protocol ID
- NCX-ASD-01
- Status last verified
- Aug 2024
- First submitted
- 5 Jun 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Efficacy and Feasibility of Using NeuroCytotron in the Treatment of Autism Spectrum Disorder: A Pilot Study
- ClinicalTrials.gov ID
- NCT06477263
- Acronym / sponsor ID
- NCX-ASD-01
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Neurocytonix, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 6 Mar 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm One | Experimental | Device: NeurocytotronAll participants |
Who may qualify
- Ages
- 3 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurocytotronNeuronal regeneration treatment | Device | Arm One |
Primary outcome
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
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
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
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
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.
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.
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.
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.
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
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)
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.
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J R Trujillo study chair
jrtrujillo@neurocytonix.com
Lorenzo R Morales Mancias principal investigator
NeuroCytonix Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurocytotron in people with Autism Spectrum Disorder, run by Neurocytonix, Inc. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen Camarillo Cardenas (+528135414706, kcamarillo@neurocytonix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Autism Diagnostic Observation Schedule-Second Edition scale scores (time frame: Through study completion, an average of 1 year). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.