Neurocytotron on Cerebral Palsy

A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Neurocytotron in Patients With Cerebral Palsy

This is a randomized, double-blinded, two-arm, placebo-controlled clinical study. The enrollment will be randomized 1:1 to Neurocytotron treatment or mock treatment (placebo).

Upon the completion of the study period, the placebo group will receive treatment, if the study results show benefits to patients.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Neurocytotron; Device: Placebo

Detailed Description

The study proposes to investigate the use of non-thermal and non-radioactive radiofrequency pulses in the brain for improving the symptoms of cerebral palsy. The proposed treatment will deliver radiofrequency pulses to the brain of patients in a non-invasive manner. The duration of the treatment will be 1 hour per day, for 28 days. After treatment, participants will be monitored for two months to detect potential adverse events and any signs of symptoms improvement. The study will be closed once 48 subjects complete the study. At the end of the study, the placebo group will have the opportunity to receive treatment with the Neurocytotron, based on the benefits shown by study results.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • San Pedro Garza García
    • Monterrey, San Pedro Garza García, Mexico, 66224
      • NeuroCytonix Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 4 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Informed Consent Form approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) signed and dated by the subject or the subject's legal representative and by the Principal Investigator. This must be obtained before the performance of any study-related procedures that are not part of normal participant care.
2. Patients 1 to 8 years old (We will include this age range because children with CP less than 1-year-old have a high mortality rate, in addition, the clinical evolution stabilizes after the second year of life, and the potential effect of treatment is optimized in the first 5 years).
3. A clinical diagnosis of spastic cerebral palsy, or spastic and dyskinetic, secondary only to hypoxic/ischemic encephalopathy
4. For spasticity, having scored at least 3 on the Ashworth scale, and 3 on the gross motor scale.
5. For dyskinesis, any degree.

Exclusion Criteria:

1. Patient with diagnosis of ataxia.
2. Current or recent history (within 2 months) of significant bacterial, fungal, viral, or mycobacterial infection.
3. Having a condition considered as causing or likely to cause co-morbidities, as determined by the investigator based on medical history, physical examination, vital signs, and clinical laboratory tests.
4. Subject with magnetic implants, pacemakers, claustrophobia or any other condition that precludes them from entering or staying in the NeuroCytotron.
5. Surgical history related to spasticity treatment.
6. Patients who have received treatment with botulinum toxin in the last 6 months.
7. 7. Children with prior neurosurgery within the past 6 months at the time of evaluation.
8. History of malignancy.
9. History of congenital heart disease.
10. Subjects who cannot or are unlikely able to comply with the protocol, according to the consensus reached by the group of study investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; Study treatment with Neurocytotron, which is a device is designed to generate a controlled beam of electromagnetic waves of certain frequencies in the presence of a magnetic field with pre-determined strength.	Device: Neurocytotron; Neurocytotron utilizes a combination of instantaneous magnetic field and low-spectrum radiofrequency waves for therapeutic purpose. Its working principle is based on the theory of magnetic resonance.
Placebo Comparator: Placebo Group; The placebo control is a mock treatment in which a subject will go through the same procedures as subjects assigned to the treatment group, only without being actually exposed to electromagnetic waves and magnetic fields.	Device: Placebo; Same treatment procedures without being actually exposed to electromagnetic waves and magnetic field

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Questionnaire	Using Pediatric Evaluation of Disability Intervention (PEDI) and Pediatric Quality of Life Inventory (PedsQL) Scales	28 Days
Spasticity	Using Ashworth Scale from Baseline and Gross Motor Scale from Baseline	28 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Use of Baseline Drug Treatment	Compared to Placebo Group	28 Days
Decreases in Use of Orthoses	Compared to Placebo Group	28 Days
Reductions in Number of Seizures or Epileptic Crisis	Compared to Placebo Group	28 Days
Changes in functional activity and brain anatomy	Using functional Magnatic Resonance Imaging (fMRI), Diffusion Tensor Imaging (DTI) and Electroencephalography (EEG)	28 Days
Evaluation of Adverse Events	Compared to Placebo Group	28 Days

Collaborators and Investigators

• Sponsor: Neurocytonix, Inc.
• Collaborators: KCRN Research, LLC
• Investigators: Study Chair: J. Roberto Trujillo, MD, ScD, NeuroCytonix, Inc.; Principal Investigator: Lorenzo R Morales Mancías, MD, NeuroCytonix Mexico

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2019
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): March 22, 2023

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: November 13, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: NCX-CP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No