Neurocytotron on Cerebral Palsy

NeuroCytonix

Status: Completed

Conditions: Cerebral Palsy

Treatments: Device: Placebo; Device: Neurocytotron

Study type: Interventional

Funder types: Industry

Identifiers

NCT03743623

NCX-CP-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 1 to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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53 participants in 2 patient groups, including a placebo group

Treatment Group

Experimental group

Description:

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.

Treatment:

Device: Neurocytotron

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Device: Placebo