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
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
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|