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A Clinical Study to Evaluate Safety and Efficacy of Neurocytotron in Patients With 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03743623
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : March 9, 2020
Sponsor:
Collaborator:
KCRN Research, LLC
Information provided by (Responsible Party):
Neurocytonix, Inc.

Brief Summary:

This is a randomized, double-blinded, two-arm, clinical study. This study is expected to last for approximately 6 months, comprised of 4-8 weeks of enrollment period, 28 days of treatment and 3 months of follow up. The enrollment will be completed prior to the beginning of initial treatment. The study will be closed when 48 subjects have completed the 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.

The placebo group will not receive treatment with Neurocytotron, unless the group assigned to the treatment shows positive results.

In the design, the 3-month follow-up period is sufficient because 100% of the patients are current patients of the research centers; therefore, patient safety will be continuously controlled after the study is closed.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 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
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study Treatment with Neurocytotron 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: Study Treatment without Neurocytotron Device: Placebo
Same treatment procedures without being actually exposed to electromagnetic waves and magnetic field




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 1 to 6 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 desgree.

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 treatment device.
  • Children with previous neurosurgery within 6 months at the time of screening.
  • History of malignancy.
  • History of congenital heart disease
  • Subjects who are unable or unlikely to comply with the protocol, determined by the majority vote of the investigators. For example, patients exposed to secondary smoking in their home environment.
  • Patients with more than 4 seizures per week, in the last 2 weeks, or more than 10 seizures in the month prior to admission.
  • Surgery related to spasticity treatment
  • Patients who have been treated with botulinum toxin in the last 6 months

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


Contacts
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Contact: Hugh Lee 301-540-2600 hughlee@kcrnresearch.com
Contact: Christine Lee

Locations
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Mexico
Hospital Universitario Dr José Eleuterio Gonzalez Recruiting
Monterrey, Mexico
Contact: J Roberto Trujillo, MD       jrtrujillo@neurocytonix.com   
Sponsors and Collaborators
Neurocytonix, Inc.
KCRN Research, LLC
Investigators
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Study Chair: Roberto Trujillo, MD, PhD Neurocytonix, Inc.
Principal Investigator: Beatriz Eugenia Chavez Luevanos, MD Hospital Universitario Dr José Eleuterio Gonzalez
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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: March 9, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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