An interventional study of Neurocytotron and Placebo in Cerebral Palsy, sponsored by Neurocytonix, Inc.. Completed at 1 site in Mexico. Open to participants aged 1 Year to 8 Years. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Neurocytonix, Inc. · Not applicable, Interventional, and Treatment
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.
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.
1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.
This study's enrollment of 53 is above the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Neurocytonix, Inc. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Neurocytotron
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.
Device: Placebo
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.
Same treatment procedures without being actually exposed to electromagnetic waves and magnetic field
Quality of Life Questionnaire
Using Pediatric Evaluation of Disability Intervention (PEDI) and Pediatric Quality of Life Inventory (PedsQL) Scales
Time frame: 28 Days
Spasticity
Using Ashworth Scale from Baseline and Gross Motor Scale from Baseline
Time frame: 28 Days
Reduction in Use of Baseline Drug Treatment
Compared to Placebo Group
Time frame: 28 Days
Decreases in Use of Orthoses
Compared to Placebo Group
Time frame: 28 Days
Reductions in Number of Seizures or Epileptic Crisis
Compared to Placebo Group
Time frame: 28 Days
Changes in functional activity and brain anatomy
Using functional Magnatic Resonance Imaging (fMRI), Diffusion Tensor Imaging (DTI) and Electroencephalography (EEG)
Time frame: 28 Days
Evaluation of Adverse Events
Compared to Placebo Group
Time frame: 28 Days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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