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| Name | Class |
|---|---|
| KCRN Research, LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | 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. |
|
| Placebo Group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurocytotron | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Questionnaire | Using Pediatric Evaluation of Disability Intervention (PEDI) and Pediatric Quality of Life Inventory (PedsQL) Scales | 28 Days |
| Spasticity | Using Ashworth Scale from Baseline and Gross Motor Scale from Baseline | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Use of Baseline Drug Treatment | Compared to Placebo Group | 28 Days |
| Decreases in Use of Orthoses | Compared to Placebo Group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. Roberto Trujillo, MD, ScD | Neurocytonix, Inc. | Study Chair |
| Lorenzo R Morales MancÃas, MD | NeuroCytonix México | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NeuroCytonix México | Monterrey | San Pedro Garza GarcÃa | 66224 | Mexico |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Placebo | Device | Same treatment procedures without being actually exposed to electromagnetic waves and magnetic field |
|
| 28 Days |
| Reductions in Number of Seizures or Epileptic Crisis | Compared to Placebo Group | 28 Days |
| Changes in functional activity and brain anatomy | Using functional Magnatic Resonance Imaging (fMRI), Diffusion Tensor Imaging (DTI) and Electroencephalography (EEG) | 28 Days |
| Evaluation of Adverse Events | Compared to Placebo Group | 28 Days |