Clinical trial NCT06477263: NeuroCytotron in the Treatment of Autism Spectrum Disorder
Official title: Preliminary Efficacy and Feasibility of Using NeuroCytotron in the Treatment of Autism Spectrum Disorder: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Neurocytonix, Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-27
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects with a confirmed diagnosis of ASD according to DSM-5 criteria.
2. Subjects ≥ 3 and ≤ 50 years.
3. Subjects with ASD severity grade 1 to 3 according to DSM-5 criteria.
4. To have the informed consent of the parents or legal representatives for the subject's participation in the study.
5. Subjects must be physically able and willing to undergo the treatment sessions.
6. Subjects must be medically and psychologically stable to participate in the study.

Exclusion Criteria:

1. Presence of medical conditions that could contraindicate the use of NeuroCytotron DM, such as severe neurological disorders and difficult-to-control epilepsy.

   1. uncontrolled epilepsy is defined as: more than 1 generalized seizure in any month within the 3 months prior to the day 1 visit, or
   2. 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.
2. Concurrent participation in other therapies or interventions for autism during the study period.
3. Logistical or situational limitations that prevent regular attendance at treatment sessions.
4. History of significant adverse reactions to similar treatments or involving the use of anesthesia.
5. Presence of serious behavioral problems or aggression that may affect the safety of the subject or staff during treatment sessions.
6. Current or recent (previous 14 days) history of clinically significant bacterial, fungal, viral or mycobacterial infection.
7. Subjects with magnetic implants, pacemakers, claustrophobia or any other condition that prevents them from entering or remaining in the DM NeuroCytotron.

Primary outcomes:
measure: Changes in Autism Diagnostic Observation Schedule-Second Edition scale scores
timeFrame: Through study completion, an average of 1 year
measure: Changes in Adaptive Behavioral Assessment System scores
timeFrame: Through study completion, an average of 1 year
measure: Changes in Childhood Autism Rating Scale scores
timeFrame: Through study completion, an average of 1 year
measure: Changes in Gilliam Autism Measurement Scale score
timeFrame: Through study completion, an average of 1 year
measure: Withdrawal Rate
timeFrame: Through study completion, an average of 1 year
measure: Adherence to Treatment
timeFrame: Through study completion, an average of 1 year
measure: Treatment Security
timeFrame: Through study completion, an average of 1 year
measure: Change in the number of seizures or epileptic seizures during the study period
timeFrame: Through study completion, an average of 1 year
measure: Neurophysiological changes: in functional activity and brain anatomy using Magnetic Resonance Imaging
timeFrame: Through study completion, an average of 1 year
measure: Neurophysiological changes: in functional activity and brain anatomy using Diffusion Tensor Imaging
timeFrame: Through study completion, an average of 1 year
measure: Neurophysiological changes: in functional activity and brain anatomy using Electroencephalogram
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Changes in comorbid symptoms
timeFrame: Through study completion, an average of 1 year
measure: Changes in sensory processing: hypersensitivity by percentile ranks
timeFrame: Through study completion, an average of 1 year
measure: Changes in sensory processing: hypersensitivity by classification scores
timeFrame: Through study completion, an average of 1 year
measure: Changes in sensory processing: hyposensitivity by percentile ranks
timeFrame: Through study completion, an average of 1 year
measure: Changes in sensory processing: hyposensitivity by classification scores
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: San Pedro Garza Garcia
country: Mexico
facility: NeuroCytonix México
state: Nuevo León
Study officials:
affiliation: jrtrujillo@neurocytonix.com
name: J R Trujillo
role: STUDY_CHAIR
affiliation: NeuroCytonix Mexico
name: Lorenzo R Morales Mancias
role: PRINCIPAL_INVESTIGATOR
References: