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Trial record 1 of 1 for:    neurocytotron | Cerebral Palsy
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Neurocytotron on Cerebral Palsy

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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.

Tracking Information
First Submitted Date  ICMJE November 9, 2018
First Posted Date  ICMJE November 16, 2018
Last Update Posted Date June 18, 2021
Actual Study Start Date  ICMJE March 22, 2019
Actual Primary Completion Date March 8, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
  • Quality of Life Questionnaire [ Time Frame: 28 Days ]
    Using Pediatric Evaluation of Disability Intervention (PEDI) and Pediatric Quality of Life Inventory (PedsQL) Scales
  • Spasticity [ Time Frame: 28 Days ]
    Using Ashworth Scale from Baseline and Gross Motor Scale from Baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
  • Reduction in Use of Baseline Drug Treatment [ Time Frame: 28 Days ]
    Compared to Placebo Group
  • Decreases in Use of Orthoses [ Time Frame: 28 Days ]
    Compared to Placebo Group
  • Reductions in Number of Seizures or Epileptic Crisis [ Time Frame: 28 Days ]
    Compared to Placebo Group
  • Changes in functional activity and brain anatomy [ Time Frame: 28 Days ]
    Using functional Magnatic Resonance Imaging (fMRI), Diffusion Tensor Imaging (DTI) and Electroencephalography (EEG)
  • Evaluation of Adverse Events [ Time Frame: 28 Days ]
    Compared to Placebo Group
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neurocytotron on Cerebral Palsy
Official Title  ICMJE A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Neurocytotron in Patients With Cerebral Palsy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Palsy
Intervention  ICMJE
  • 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.
  • Device: Placebo
    Same treatment procedures without being actually exposed to electromagnetic waves and magnetic field
Study Arms  ICMJE
  • 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.
    Intervention: Device: Neurocytotron
  • 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.
    Intervention: Device: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2021)
52
Original Estimated Enrollment  ICMJE
 (submitted: November 13, 2018)
48
Actual Study Completion Date  ICMJE June 11, 2021
Actual Primary Completion Date March 8, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03743623
Other Study ID Numbers  ICMJE NCX-CP-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Neurocytonix, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Neurocytonix, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE KCRN Research, LLC
Investigators  ICMJE
Study Chair: J. Roberto Trujillo, MD, ScD Neurocytonix, Inc.
Principal Investigator: Lorenzo R Morales Mancías, MD Center for Research and Development in Health Sciences
PRS Account Neurocytonix, Inc.
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP