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History of Changes for Study: NCT03743623
A Clinical Study to Evaluate Safety and Efficacy of Neurocytotron in Patients With Cerebral Palsy
Latest version (submitted June 17, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 13, 2018 None (earliest Version on record)
2 April 12, 2019 Recruitment Status, Study Status and Contacts/Locations
3 June 14, 2019 Contacts/Locations and Study Status
4 March 6, 2020 Study Status
5 December 22, 2020 Contacts/Locations, Study Status, Arms and Interventions, Eligibility, Study Description, IPDSharing and Study Identification
6 December 28, 2020 Contacts/Locations and Study Status
7 April 19, 2021 Study Status
8 April 26, 2021 Recruitment Status, Contacts/Locations, Study Status and Study Design
9 June 17, 2021 Recruitment Status and Study Status
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Study NCT03743623
Submitted Date:  November 13, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: NCX-CP-01
Brief Title: A Clinical Study to Evaluate Safety and Efficacy of Neurocytotron in Patients With Cerebral Palsy
Official Title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Neurocytotron in Patients With Cerebral Palsy
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2018
Overall Status: Not yet recruiting
Study Start: December 2018
Primary Completion: April 2019 [Anticipated]
Study Completion: July 2019 [Anticipated]
First Submitted: November 9, 2018
First Submitted that
Met QC Criteria:
November 13, 2018
First Posted: November 16, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
November 13, 2018
Last Update Posted: November 16, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Neurocytonix, Inc.
Responsible Party: Sponsor
Collaborators: KCRN Research, LLC
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.

Detailed Description:
Open or close this module Conditions
Conditions: Cerebral Palsy
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 48 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 1 Year
Maximum Age: 6 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Daniel Zang, PhD, JD
Telephone: 3018200926
Email: dan@innovcell.com
Central Contact Backup: Hugh Lee
Study Officials: Roberto Trujillo, MD, PhD
Study Chair
Neurocytonix, Inc.
Beatriz Eugenia Chavez Luevanos, MD
Principal Investigator
Hospital Universitario Dr José Eleuterio Gonzalez
Locations: Mexico
Hospital Universitario Dr José Eleuterio Gonzalez
Monterrey, Mexico
Contact:Contact: Dora Elia Cortés Hernandez, MD dora.cortesh@uanl.mx
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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