Neurocytotron on Cerebral Palsy

NCT03743623 | Completed

• 1 other identifier: NCX-CP-01
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Reduction in Use of Baseline Drug Treatment

  28 Days

• Decreases in Use of Orthoses

  28 Days

• Reductions in Number of Seizures or Epileptic Crisis

  28 Days

• Changes in functional activity and brain anatomy

  28 Days

• Evaluation of Adverse Events

  28 Days

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Neurocytotron DEVICE

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.

Treatment Group

Placebo DEVICE

Same treatment procedures without being actually exposed to electromagnetic waves and magnetic field

Placebo Group

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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).
• A clinical diagnosis of spastic cerebral palsy, or spastic and dyskinetic, secondary only to hypoxic/ischemic encephalopathy
• For spasticity, having scored at least 3 on the Ashworth scale, and 3 on the gross motor scale.
• For dyskinesis, any degree.

You may not qualify if:

• Patient with diagnosis of ataxia.
• Current or recent history (within 2 months) of significant bacterial, fungal, viral, or mycobacterial infection.
• 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.
• Subject with magnetic implants, pacemakers, claustrophobia or any other condition that precludes them from entering or staying in the NeuroCytotron.
• Surgical history related to spasticity treatment.
• Patients who have received treatment with botulinum toxin in the last 6 months.
• \. Children with prior neurosurgery within the past 6 months at the time of evaluation.
• History of malignancy.
• History of congenital heart disease.
• Subjects who cannot or are unlikely able to comply with the protocol, according to the consensus reached by the group of study investigators.

Sponsors & Collaborators

• Neurocytonix, Inc.: lead
• KCRN Research, LLC: collaborator

Study Sites (1)

NeuroCytonix México

Monterrey, San Pedro Garza García, 66224, Mexico

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• J. Roberto Trujillo, MD, ScD

  Neurocytonix, Inc.

  STUDY CHAIR

• Lorenzo R Morales Mancías, MD

  NeuroCytonix México

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 16, 2018
• Study Start: March 22, 2019
• Primary Completion: December 15, 2022
• Study Completion: March 22, 2023
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)