34 Participants NeededMy employer runs this trial

Melillo Method for Neurodevelopmental Disorders

(ILL Trial)

Recruiting at 1 trial location
AV
Overseen ByAssociate Vice President of Research
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Life University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a brain-training program called the Melillo Method®, designed to assist children with learning and behavior challenges in school. The study will determine if the program, which includes activities like sensory exercises and balance training, can be effectively delivered in a school setting. Children identified by teachers as needing extra support and attending specific schools in Illinois may be suitable candidates. The trial aims to assess the feasibility of a larger study and the program's practicality and acceptability for families and schools. As an unphased trial, it offers an opportunity to contribute to innovative educational solutions that could benefit many children.

What prior data suggests that the Melillo Method is safe for children with neurodevelopmental disorders?

Research has shown that the Melillo Method®, which incorporates sensory activities and exercises, is generally safe. Studies on similar light-based treatments suggest these methods are both safe and practical. These treatments have demonstrated good safety records, with only mild side effects reported in other contexts. Although limited data exists specifically for children, the treatment's components are non-invasive and have been well-tolerated in related studies. Participants in previous research involving sensory and rhythm exercises reported few side effects, indicating that the Melillo Method® could be a safe option for children in clinical trials.12345

Why are researchers excited about this trial?

Researchers are excited about the Melillo Method for neurodevelopmental disorders because it takes a holistic approach that differs from standard treatments like medication and behavioral therapy. This method focuses on integrating sensory, motor, and cognitive exercises, which aim to balance brain activity and enhance neuroplasticity. Unlike traditional treatments that often address symptoms, the Melillo Method seeks to target the root causes of neurodevelopmental imbalances, offering a potentially transformative impact on brain function.

What evidence suggests that the Melillo Method is effective for neurodevelopmental disorders?

Research has shown that the Melillo Method might help children with learning and behavior problems. In this trial, participants in the Immediate-start arm will receive approximately 24 weeks of Melillo Method therapy, while those in the Delayed-start arm will wait before receiving approximately 12 weeks of therapy. Studies have found that this program, which includes activities to stimulate the senses and improve movement, can help children with ADHD and autism better control their impulses. Another study discovered that working on primitive reflexes (automatic movements babies make that usually go away as they grow) is linked to higher thinking skills. These findings suggest that the Melillo Method could support better brain function and behavior in children with developmental challenges. However, more research is needed to confirm these results.678910

Who Is on the Research Team?

TP

Tyson Perez

Principal Investigator

Life University

Are You a Good Fit for This Trial?

This trial is for children aged 8 and older in elementary or middle school who are having difficulties with behavior or learning, as identified by teachers or staff. Families must complete a short questionnaire to confirm eligibility.

Inclusion Criteria

Attends Roodhouse Elementary or North Greene Jr. High School
Screening SDQ-P Total Difficulties Score ≥17 and Total Impact Score ≥2
I am at least 8 years old.

Exclusion Criteria

I do not have impairments that prevent me from completing tests or therapy.
I have a history of epilepsy.
I have been diagnosed with ODD or Conduct Disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immediate-start Treatment

Participants receive Melillo Method therapy for approximately 24 weeks, 3 times per week

24 weeks
72 sessions (in-person)

Delayed-start Treatment

Participants on the waitlist receive Melillo Method therapy for approximately 12 weeks, 3 times per week

12 weeks
36 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Melillo Method®

Trial Overview

The study tests the Melillo Method®, a brain-training program using sensory activities, rhythm exercises, reflex integration, and balance training. Children are randomly assigned to start right away or after a delay; all receive the program in small groups at school.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Immediate-startExperimental Treatment1 Intervention
Group II: Delayed-startActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Life University

Lead Sponsor

Trials
21
Recruited
450+

Citations

The Relationship between Retained Primitive Reflexes and ...

Results: Support was found for the observation that reduction of retained primitive reflexes following unilateral T.E.N.S. stimulation was ...

Analysis of Autism Spectrum Disorder and Attention Deficit

Based on research conducted by Melillo (2009), progress in the program is a huge relief to any parent or administrator. One can detect unusual things that were ...

Effectiveness Of Neuro-Developmental Therapy In ...

Melillo, R. (2016) Persistent primitive reflexes and childhood neurobehavioral disorders. Neuroplasticity in learning and rehabilitation.

The Melillo Method

The Melillo Method is a way to help people with learning and behavior issues caused by problems in their brain and nerves.

Evaluating-the-Effectiveness-of-Noninvasive-ADHD-Autism ...

The treatment methods used in combination were found to be effective in improving response inhibition scores in the paired groups for all admitted individuals ...

Probing the Neurodynamic Mechanisms of Cognitive ...

Methods: We analyzed data from an open-label pilot study involving nine participants with ASD and treatment-resistant depression who received 30 sessions of ...

Photobiomodulation (PBM) holds great potential for reducing ...

Several other clinical studies with near-infrared light suggests that this treatment is a safe and feasible approach. Our preliminary data was ...

Neurobiological Basis of Autism | Request PDF

Autism is a heterogeneous neurodevelopmental disorder in which there exists a complex interaction (s) between genetic and environmental risk factors. Autism is ...

A Systems Biology Perspective on Childhood ADHD ...

mild side effects Limited data for adults; promising safety profile. Limited pediatric data Ineffective at higher doses; mild tolerability ...

I run this lab for kids with developmental delays, autism ...

Robert Melillo has shown in his research. Brain-wave data collected during a hearing test routinely given to newborns could help clinicians ...