Functional Neurogenesis Stimulation Therapy for Autism

Not yet recruiting at 1 trial location

Overseen By Karen P Camarillo Cardenas

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Neurocytonix, Inc.

Disqualifiers: Severe neurological disorders, Uncontrolled epilepsy, Other autism therapies, others

Compensation: Varies

Number of Visits: 32

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a noninvasive brain treatment, called Functional Neurogenesis Stimulation Therapy, can improve core symptoms of autism in children. The focus is on enhancing social communication and interaction while reducing repetitive behaviors. Children with autism who use some spoken language and have stable medications might be suitable candidates. Participants will receive either real treatments or placebo sessions, without knowing which they receive. The findings could lead to new, safe treatments for autism. As an unphased trial, this study offers a unique opportunity for participants to contribute to pioneering research that could shape future autism therapies.

Will I have to stop taking my current medications?

The trial requires that participants be stable on their current medications for at least 4 weeks before starting the study, so you won't need to stop taking them.

What prior data suggests that the NeuroCytotron device is safe for children with autism?

Research has shown that noninvasive brain treatments, such as Functional Neurogenesis Stimulation, are usually well-tolerated by patients. Studies have found that this therapy can reduce symptoms of autism spectrum disorder (ASD) without major side effects. The treatment uses low-energy electromagnetic fields, similar to those in MRI scans, which are safe and have been used for other conditions.

Possible risks include discomfort from lying still during treatment, anxiety about the device, and side effects from sedation if an MRI is needed. However, these issues are generally manageable and not directly caused by the stimulation itself. Current studies have not identified any serious side effects specific to the NeuroCytotron device, making it a promising and safe option for further research in children with ASD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Functional Neurogenesis Stimulation Therapy is unique because it takes a novel approach to treating autism by potentially encouraging the brain to grow new, functional neurons. Unlike traditional treatments, which often focus on managing symptoms through behavioral therapy or medication, this therapy aims to address the root of neurological differences. Researchers are excited about its potential to not just alleviate symptoms but to fundamentally alter brain function, offering a new avenue of hope for more profound improvements in individuals with autism.

What evidence suggests that Functional Neurogenesis Stimulation Therapy might be an effective treatment for autism?

Research has shown that non-invasive brain stimulation methods, such as Functional Neurogenesis Stimulation, can improve behavior and thinking in people with autism spectrum disorder (ASD). In this trial, participants will receive either Functional Neurogenesis Stimulation Therapy or be part of a placebo control group. Similar treatments have shown promise in reducing symptoms like repetitive actions and difficulties with social communication. Although detailed guidelines are still being developed, early studies on brain stimulation have shown positive results in related conditions. This suggests that Functional Neurogenesis Stimulation might help with core symptoms of ASD, but more research is needed to confirm these effects. ^{1 2 3 4 5}

Who Is on the Research Team?

Jose R Trujillo, M.D., Sc.D.

Principal Investigator

Neurocytonix, Inc.

Lorenzo R Morales Mancias, M.D.

Principal Investigator

Neurocytonix, Inc.

Are You a Good Fit for This Trial?

This trial is for boys and girls aged 3 to 12 with Autism Spectrum Disorder (ASD) who can speak at least a little. They should be diagnosed as level 1-2 according to DSM-5 criteria. Children cannot participate if they have conditions that make the treatment unsafe or could interfere with the study results.

Inclusion Criteria

I am both mentally and physically stable enough to participate in a study.

Male or female subjects with a confirmed diagnosis of ASD according to DSM-5 criteria

Participants must have functional use of language to engage with assessments

Exclusion Criteria

I have had a serious infection recently.

Exclusion of participants diagnosed with ASD presenting specific conditions identified through imaging studies

Presence of incompatible implanted medical devices or metallic foreign bodies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily, 1-hour sessions of either active NeuroCytotron or sham treatment for 28 days

4 weeks

28 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Functional Neurogenesis Stimulation Therapy

Trial Overview

The study tests Functional Neurogenesis Stimulation Therapy using the NeuroCytotron device against a placebo in improving ASD symptoms. Kids are randomly chosen to get either real or sham treatments, without families or staff knowing which one. The focus is on changes in social skills and behaviors.

How Is the Trial Designed?

Group I: Functional Neurogenesis Stimulation Therapy Treatment Group Experimental Treatment 1 Intervention

Group treated with Functional Neurogenesis Stimulation Therapy (NeuroCytotron)

Group II: Placebo Control Group Placebo Group 1 Intervention

Group not treated with Functional Neurogenesis Stimulation Therapy (NeuroCytotron)

Who Is Running the Clinical Trial?

Neurocytonix, Inc.

Lead Sponsor

Trials

2

Recruited

150+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07276555

Efficacy and Safety of Functional Neurogenesis Stimulation ...

The primary outcome is the change in ADOS-2 total score from baseline to 12 weeks post-treatment, comparing participants treated with ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12684251/

Efficacy and Safety of Neuromodulation Interventions for ...

Neuromodulation interventions have been employed in ASD, which can improve behavioral and cognitive outcomes in ASD, especially relief of ...

3.

ctv.veeva.com

ctv.veeva.com/study/efficacy-and-safety-of-functional-neurogenesis-stimulation-therapy-in-children-with-autism-spectrum

Efficacy and Safety of Functional Neurogenesis Stimulation ...

This study will test whether a noninvasive brain stimulation treatment called Functional Neurogenesis Stimulation (using the NeuroCytotron ...

4.

neurocytonix.com

neurocytonix.com/our-technology/clinical-trials

Clinical Trials

We have studied our approach to functional neurogenesis stimulation in a rigorous clinical trial on cerebral palsy and a series of open-label case studies.

5.

frontiersin.org

frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.989905/full

Effects of non-invasive neurostimulation on autism ...

Non-invasive neurostimulation techniques (NIBS) have shown benefits in psychiatric conditions. While in ASD patients, no guideline has so-far been recommended.