A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Neurocytotron in Patients With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Quality of Life Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
结局指标
主要结局
Quality of Life Questionnaire
时间窗: 28 Days
Using Pediatric Evaluation of Disability Intervention (PEDI) and Pediatric Quality of Life Inventory (PedsQL) Scales
Spasticity
时间窗: 28 Days
Using Ashworth Scale from Baseline and Gross Motor Scale from Baseline
次要结局
- Reductions in Number of Seizures or Epileptic Crisis(28 Days)
- Reduction in Use of Baseline Drug Treatment(28 Days)
- Decreases in Use of Orthoses(28 Days)
- Changes in functional activity and brain anatomy(28 Days)
- Evaluation of Adverse Events(28 Days)