Our TechnologyClinical Trials

Our research may offer new hope for healing neurological disorders #

Clinical trials are crucial to our research process. 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 on participants with other neurological conditions. Encouraged by promising results from our initial clinical trial with children suffering from cerebral palsy, we have expanded our trials to assess the impact of our protocol on autism spectrum disorders and have also developed protocols for stroke, traumatic brain injury (TBI), vascular dementia, and the neurological impacts of COVID-19.

See which neurological disorders we are focused on

Our Clinical Trial Standards #

Our clinical trials are conducted after carefully analyzing the patient's health and medical history to ensure they are eligible for the protocol study. We strictly follow Good Clinical Practice guidelines, which are U.S. regulatory standards set to safeguard the rights, integrity, and confidentiality of patients involved in the trials. Adherence to these standards helps ensure ethical conduct and reliable outcomes in our research efforts. 

We employ robust data monitoring and safety oversight, engage proficient investigators, and use advanced data collection and analysis tools. With each clinical study, we gain invaluable insights, bringing us closer to developing effective treatments that could transform the future of neurological health.

The Role of Technology in Our Protocol #

The core of our protocol utilizes a medical device that emits low-spectrum radio frequencies. We are evaluating whether these frequencies stimulate neurogenesis and increase the functionality of non-functioning or damaged brain cells. 

Our protocols are tailored for specific neurological conditions. After our clinical trials and research, we monitor participants for two months to look for potential adverse events and document symptoms improvements. 

Learn About Our Innovative Technology

Our First Randomized Clinical Trial (RCT) for Cerebral Palsy #

Randomized Clinical Trial (RCT) clinical studies are considered the gold standard for scientific experiments involving humans. Clinical trials of this kind are conducted without the participants or researchers knowing who receives the investigational treatment and who is given a placebo. 

In 2019, we conducted our first clinical trial to evaluate the safety and efficacy of our medical device for children with cerebral palsy. We recruited 50 children for the study, of which 26 were assigned to the protocol group and 24 to the placebo group. To understand the safety of our protocol, we closely monitored participants for adverse reactions during the trial. 

Efficacy was measured using tools like the Pediatric Evaluation of Disability Index, which determines a child's ability to self-care, move around, and interact socially, and the Pediatric Quality of Life Inventory, which assesses children's well-being emotionally, physically, and socially. Another efficacy measured was the degree of spasticity or stiffness in the muscles.

More about our cerebral palsy clinical trial on ClinicalTrials.gov.

Patients enrolled in the study did not experience significant adverse events. Patients treated with the protocol had statistically significant improvements in efficacy measurements compared to placebo.

The Mexican regulatory authority COFEPRIS equivalent to the U.S. FDA acknowledged the results of our cerebral palsy clinical trial and approved the protocol. We are working towards FDA authorization.  We are preparing several manuscripts detailing the clinical trial results, which will soon be submitted to various scientific journals.

Our COFEPRIS-approved cerebral palsy treatment protocol

Ongoing Research and Future Trials #

Research and clinical trials form the foundation of our efforts to deliver innovative treatments to people with neurological conditions. They are currently conducted at our NeuroCytonix Mexico center in Monterrey. After the successful completion of our first trial on cerebral palsy, as part of our next clinical trials, we are evaluating the protocol for people with autism spectrum disorder, in an experimental pilot study. We continue to research protocols for other neurological conditions, such as stroke, traumatic brain injury (TBI), vascular dementia, and neurological impacts of COVID-19.

Evaluating our Autism Protocol #

During early index cases, we studied the results of our protocol for autistic children with higher support needs. Following the treatment, children demonstrated lower scores on the Autism Diagnostic Observation Schedule-Second Edition (ADOS-2) Scale, reflecting improvements in behavior. They appeared calmer, more communicative, focused, and engaged with the world around them compared to their baseline behaviors before starting the protocol. Based on the promising findings of our index cases, the next step in our clinical trials is evaluating the preliminary efficacy and feasibility of treating autism spectrum disorder.

See our autism spectrum disorder clinical trial on ClinicalTrials.gov.

Preparing for Clinical Trials #

To prepare for our clinical trials or open-label research, follow these steps: 

• Review the informed consent document on the study's purpose, procedures, risks, and benefits.
• Discuss any concerns with our research team and ensure you meet all eligibility criteria.
• Provide a comprehensive medical history to our investigators.
• Plan your schedule to accommodate the protocol study duration and post-study follow-ups.
• Take note of the study duration, required visits, pre-trial tests, and potential side effects to ensure you have all the necessary information.
• Maintain open communication with our research team and closely follow all study instructions.
• Keep a personal record of your protocol experience and any side effects that can help you and our team.

 

To find out if you or a loved one are eligible for our protocols, please contact us.