Cerebral PalsyNCT03743623
Neurocytotron on Cerebral Palsy
A study testing Neurocytotron in people with Cerebral Palsy, run by Neurocytonix, Inc. at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Neurocytotron
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteMexico
- Study dates
- 22 Mar 2019to 22 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- 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).
- A clinical diagnosis of spastic cerebral palsy, or spastic and dyskinetic, secondary only to hypoxic/ischemic encephalopathy
- For spasticity, having scored at least 3 on the Ashworth scale, and 3 on the gross motor scale.
- For dyskinesis, any degree.
Who cannot join
- Patient with diagnosis of ataxia.
- Current or recent history (within 2 months) of significant bacterial, fungal, viral, or mycobacterial infection.
- 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.
- Subject with magnetic implants, pacemakers, claustrophobia or any other condition that precludes them from entering or staying in the NeuroCytotron.
- Surgical history related to spasticity treatment.
- Patients who have received treatment with botulinum toxin in the last 6 months.
Show all 10Show fewer
- 7. Children with prior neurosurgery within the past 6 months at the time of evaluation.
- History of malignancy.
- History of congenital heart disease.
- Subjects who cannot or are unlikely able to comply with the protocol, according to the consensus reached by the group of study investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Neurocytotron in Patients With Cerebral Palsy
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.
Read the 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
- Being tested
- Neurocytotron, Placebo
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurocytotronDevice
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.
PlaceboDevice
Same treatment procedures without being actually exposed to electromagnetic waves and magnetic field
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 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. Receives: Device: Neurocytotron |
| Placebo Group | Placebo comparator | 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. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Questionnaire
Using Pediatric Evaluation of Disability Intervention (PEDI) and Pediatric Quality of Life Inventory (PedsQL) Scales
Measured: 28 Days
Spasticity
Using Ashworth Scale from Baseline and Gross Motor Scale from Baseline
Measured: 28 Days
Secondary outcomes (5)
Reduction in Use of Baseline Drug Treatment
Compared to Placebo Group
Measured: 28 Days
Decreases in Use of Orthoses
Compared to Placebo Group
Measured: 28 Days
Reductions in Number of Seizures or Epileptic Crisis
Compared to Placebo Group
Measured: 28 Days
Changes in functional activity and brain anatomy
Using functional Magnatic Resonance Imaging (fMRI), Diffusion Tensor Imaging (DTI) and Electroencephalography (EEG)
Measured: 28 Days
Evaluation of Adverse Events
Compared to Placebo Group
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start22 Mar 2019
- Primary completion15 Dec 2022
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocytonix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KCRN Research, LLC
- Responsible party
- Sponsor
- Investigators
- J. Roberto Trujillo, MD, ScD, Study chair, Neurocytonix, Inc.Lorenzo R Morales Mancías, MD, Principal investigator, NeuroCytonix México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743623
- Sponsor's protocol ID
- NCX-CP-01
- Status last verified
- Feb 2025
- First submitted
- 9 Nov 2018
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Neurocytotron in Patients With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03743623
- Acronym / sponsor ID
- NCX-CP-01
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Neurocytonix, Inc.Industry (pharma, biotech, devices)
- Collaborators
- KCRN Research, LLC
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: NeurocytotronStudy 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. |
| Placebo Group | Placebo comparator | Device: PlaceboThe 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. |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
- 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).
- A clinical diagnosis of spastic cerebral palsy, or spastic and dyskinetic, secondary only to hypoxic/ischemic encephalopathy
- For spasticity, having scored at least 3 on the Ashworth scale, and 3 on the gross motor scale.
- For dyskinesis, any degree.
Key exclusion criteria (10 listed)
- Patient with diagnosis of ataxia.
- Current or recent history (within 2 months) of significant bacterial, fungal, viral, or mycobacterial infection.
- 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.
- Subject with magnetic implants, pacemakers, claustrophobia or any other condition that precludes them from entering or staying in the NeuroCytotron.
- Surgical history related to spasticity treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurocytotronNeurocytotron 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 | Treatment Group |
| PlaceboSame treatment procedures without being actually exposed to electromagnetic waves and magnetic field | Device | Placebo Group |
Primary outcome
Quality of Life Questionnaire
Time frame: 28 Days
Using Pediatric Evaluation of Disability Intervention (PEDI) and Pediatric Quality of Life Inventory (PedsQL) Scales
Spasticity
Time frame: 28 Days
Using Ashworth Scale from Baseline and Gross Motor Scale from Baseline
5 secondary outcomes
Reduction in Use of Baseline Drug Treatment
Time frame: 28 Days
Decreases in Use of Orthoses
Time frame: 28 Days
Reductions in Number of Seizures or Epileptic Crisis
Time frame: 28 Days
Changes in functional activity and brain anatomy
Time frame: 28 Days
Evaluation of Adverse Events
Time frame: 28 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Roberto Trujillo, MD, ScD study chair
Neurocytonix, Inc.
Lorenzo R Morales Mancías, MD principal investigator
NeuroCytonix México
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurocytotron in people with Cerebral Palsy, run by Neurocytonix, Inc. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Questionnaire (time frame: 28 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.