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
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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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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.
Same treatment procedures without being actually exposed to electromagnetic waves and magnetic field
- 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
- 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
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|Ages Eligible for Study:||1 Year to 8 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|Center for Research and Development in Health Sciences|
|Monterrey, Nuevo León, Mexico, 64460|
|Study Chair:||J. Roberto Trujillo, MD, ScD||Neurocytonix, Inc.|
|Principal Investigator:||Lorenzo R Morales Mancías, MD||Center for Research and Development in Health Sciences|
|Responsible Party:||Neurocytonix, Inc.|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Nervous System Diseases
Brain Damage, Chronic
Central Nervous System Diseases