Clinical trial NCT03743623: Neurocytotron on Cerebral Palsy
Official title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Neurocytotron in Patients With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Neurocytonix, Inc.
Sponsor class: INDUSTRY
Collaborators: name: KCRN Research, LLC
First posted: 2018-11-16
Enrollment: 53
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Life Questionnaire
timeFrame: 28 Days
measure: Spasticity
timeFrame: 28 Days
Secondary outcomes:
measure: Reduction in Use of Baseline Drug Treatment
timeFrame: 28 Days
measure: Decreases in Use of Orthoses
timeFrame: 28 Days
measure: Reductions in Number of Seizures or Epileptic Crisis
timeFrame: 28 Days
measure: Changes in functional activity and brain anatomy
timeFrame: 28 Days
measure: Evaluation of Adverse Events
timeFrame: 28 Days
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: NeuroCytonix México
state: San Pedro Garza García
Study officials:
affiliation: Neurocytonix, Inc.
name: J. Roberto Trujillo, MD, ScD
role: STUDY_CHAIR
affiliation: NeuroCytonix México
name: Lorenzo R Morales Mancías, MD
role: PRINCIPAL_INVESTIGATOR
References: