Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
48

Summary

Conditions
Cerebral Palsy
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 1 years and 8 years
Gender
Both males and females

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 wil...

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.

Tracking Information

NCT #
NCT03743623
Collaborators
KCRN Research, LLC
Investigators
Study Chair: J. Roberto Trujillo, MD, ScD Neurocytonix, Inc. Principal Investigator: Lorenzo R Morales Mancías, MD Center for Research and Development in Health Sciences