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Neurocytotron on Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status

Completed

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Neurocytotron

Placebo

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

1 Year - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
7. 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.

Sites / Locations

Center for Research and Development in Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Group

Placebo Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Quality of Life Questionnaire

Using Pediatric Evaluation of Disability Intervention (PEDI) and Pediatric Quality of Life Inventory (PedsQL) Scales

Spasticity

Using Ashworth Scale from Baseline and Gross Motor Scale from Baseline

Secondary Outcome Measures

Reduction in Use of Baseline Drug Treatment

Compared to Placebo Group

Decreases in Use of Orthoses

Compared to Placebo Group

Reductions in Number of Seizures or Epileptic Crisis

Compared to Placebo Group

Changes in functional activity and brain anatomy

Using functional Magnatic Resonance Imaging (fMRI), Diffusion Tensor Imaging (DTI) and Electroencephalography (EEG)

Evaluation of Adverse Events

Compared to Placebo Group

Full Information

NCT ID

NCT03743623

First Posted

November 9, 2018

Last Updated

June 17, 2021

Sponsor

Neurocytonix, Inc.

Collaborators

KCRN Research, LLC

1. Study Identification

Unique Protocol Identification Number

NCT03743623

Brief Title

Neurocytotron on Cerebral Palsy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

March 22, 2019 (Actual)

Primary Completion Date

March 8, 2021 (Actual)

Study Completion Date

June 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Neurocytonix, Inc.

Collaborators

KCRN Research, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group

Arm Type

Experimental

Arm Description

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Neurocytotron

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Quality of Life Questionnaire

Description

Using Pediatric Evaluation of Disability Intervention (PEDI) and Pediatric Quality of Life Inventory (PedsQL) Scales

Time Frame

28 Days

Title

Spasticity

Description

Using Ashworth Scale from Baseline and Gross Motor Scale from Baseline

Time Frame

28 Days

Secondary Outcome Measure Information:

Title

Reduction in Use of Baseline Drug Treatment

Description

Compared to Placebo Group

Time Frame

28 Days

Title

Decreases in Use of Orthoses

Description

Compared to Placebo Group

Time Frame

28 Days

Title

Reductions in Number of Seizures or Epileptic Crisis

Description

Compared to Placebo Group

Time Frame

28 Days

Title

Changes in functional activity and brain anatomy

Description

Using functional Magnatic Resonance Imaging (fMRI), Diffusion Tensor Imaging (DTI) and Electroencephalography (EEG)

Time Frame

28 Days

Title

Evaluation of Adverse Events

Description

Compared to Placebo Group

Time Frame

28 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 7. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

J. Roberto Trujillo, MD, ScD

Organizational Affiliation

Neurocytonix, Inc.

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Lorenzo R Morales Mancías, MD

Organizational Affiliation

Center for Research and Development in Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Research and Development in Health Sciences

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64460

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

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Neurocytotron on Cerebral Palsy

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