NCT03743623

Neurocytotron on Cerebral Palsy

A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Neurocytotron in Patients With Cerebral Palsy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Neurocytonix, Inc. · Industry
• Sex: All
• Age: 1 Year – 8 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
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.
DEVICE	Placebo	Same treatment procedures without being actually exposed to electromagnetic waves and magnetic field

Timeline

• Start date: 2019-03-22
• Primary completion: 2022-12-15
• Completion: 2023-03-22
• First posted: 2018-11-16
• Last updated: 2025-02-13

Locations

1 site across 1 country: Mexico