Neurocytotron on Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03743623
• Other study ID #: NCX-CP-01
• Status: Completed
• Phase: N/A
• Start date: March 22, 2019
• Est. completion date: June 11, 2021

Study information

• Verified date: June 2021
• Source: Neurocytonix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 11, 2021
• Est. primary completion date: March 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 8 Years

Eligibility

Inclusion Criteria:

1. Informed Consent Form approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) signed and dated by the subject or the subject's legal representative and by the Principal Investigator. This must be obtained before the performance of any study-related procedures that are not part of normal participant care.

2. Patients 1 to 8 years old (We will include this age range because children with CP less than 1-year-old have a high mortality rate, in addition, the clinical evolution stabilizes after the second year of life, and the potential effect of treatment is optimized in the first 5 years).

3. A clinical diagnosis of spastic cerebral palsy, or spastic and dyskinetic, secondary only to hypoxic/ischemic encephalopathy

4. For spasticity, having scored at least 3 on the Ashworth scale, and 3 on the gross motor scale.

5. For dyskinesis, any degree.

Exclusion Criteria:

1. Patient with diagnosis of ataxia.

2. Current or recent history (within 2 months) of significant bacterial, fungal, viral, or mycobacterial infection.

3. Having a condition considered as causing or likely to cause co-morbidities, as determined by the investigator based on medical history, physical examination, vital signs, and clinical laboratory tests.

4. Subject with magnetic implants, pacemakers, claustrophobia or any other condition that precludes them from entering or staying in the NeuroCytotron.

5. Surgical history related to spasticity treatment.

6. Patients who have received treatment with botulinum toxin in the last 6 months.

7. 7. Children with prior neurosurgery within the past 6 months at the time of evaluation.

8. History of malignancy.

9. History of congenital heart disease.

10. Subjects who cannot or are unlikely able to comply with the protocol, according to the consensus reached by the group of study investigators.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.
• Placebo
Same treatment procedures without being actually exposed to electromagnetic waves and magnetic field

Locations

Country	Name	City	State
Mexico	Center for Research and Development in Health Sciences	Monterrey	Nuevo León

Sponsors (2)

Lead Sponsor	Collaborator
Neurocytonix, Inc.	KCRN Research, LLC

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life Questionnaire	Using Pediatric Evaluation of Disability Intervention (PEDI) and Pediatric Quality of Life Inventory (PedsQL) Scales	28 Days
Primary	Spasticity	Using Ashworth Scale from Baseline and Gross Motor Scale from Baseline	28 Days
Secondary	Reduction in Use of Baseline Drug Treatment	Compared to Placebo Group	28 Days
Secondary	Decreases in Use of Orthoses	Compared to Placebo Group	28 Days
Secondary	Reductions in Number of Seizures or Epileptic Crisis	Compared to Placebo Group	28 Days
Secondary	Changes in functional activity and brain anatomy	Using functional Magnatic Resonance Imaging (fMRI), Diffusion Tensor Imaging (DTI) and Electroencephalography (EEG)	28 Days
Secondary	Evaluation of Adverse Events	Compared to Placebo Group	28 Days