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Neurocytotron on Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03743623
Recruitment Status : Completed
First Posted : November 16, 2018
Last Update Posted : June 18, 2021
Sponsor:
Collaborator:
KCRN Research, LLC
Information provided by (Responsible Party):
Neurocytonix, Inc.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cerebral Palsy Device: Neurocytotron Device: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Neurocytotron in Patients With Cerebral Palsy
Actual Study Start Date : March 22, 2019
Actual Primary Completion Date : March 8, 2021
Actual Study Completion Date : June 11, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Quality of Life Questionnaire [ Time Frame: 28 Days ]
    Using Pediatric Evaluation of Disability Intervention (PEDI) and Pediatric Quality of Life Inventory (PedsQL) Scales

  2. Spasticity [ Time Frame: 28 Days ]
    Using Ashworth Scale from Baseline and Gross Motor Scale from Baseline


Secondary Outcome Measures :
  1. Reduction in Use of Baseline Drug Treatment [ Time Frame: 28 Days ]
    Compared to Placebo Group

  2. Decreases in Use of Orthoses [ Time Frame: 28 Days ]
    Compared to Placebo Group

  3. Reductions in Number of Seizures or Epileptic Crisis [ Time Frame: 28 Days ]
    Compared to Placebo Group

  4. Changes in functional activity and brain anatomy [ Time Frame: 28 Days ]
    Using functional Magnatic Resonance Imaging (fMRI), Diffusion Tensor Imaging (DTI) and Electroencephalography (EEG)

  5. Evaluation of Adverse Events [ Time Frame: 28 Days ]
    Compared to Placebo Group


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743623


Locations
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Mexico
Center for Research and Development in Health Sciences
Monterrey, Nuevo León, Mexico, 64460
Sponsors and Collaborators
Neurocytonix, Inc.
KCRN Research, LLC
Investigators
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Study Chair: J. Roberto Trujillo, MD, ScD Neurocytonix, Inc.
Principal Investigator: Lorenzo R Morales Mancías, MD Center for Research and Development in Health Sciences
More Information
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Responsible Party: Neurocytonix, Inc.
ClinicalTrials.gov Identifier: NCT03743623    
Other Study ID Numbers: NCX-CP-01
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases