Clinical Study of Treatment of Acute Spinal Cord Injury by Near Infrared Light Irradiation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Baseline ASIA Rating Scale at 6 Months
研究概览
简要总结
The purpose of this study was to observe the therapeutic effect of near-infrared light irradiation on the treatment of acute spinal cord injury in humans, and whether it can promote the recovery of neurological function. Half of the patients underwent laminectomy and decompression surgery, and the other half of the patients were implanted with irradiated fibers for irradiation after surgery.
详细描述
The annual incidence of spinal cord injury has increased year by year, and there is currently no effective treatment.
Near-infrared light has been widely used in clinical medicine because of its bio-stimulating effect, convenient use, harmless to the body, easy to be accepted by patients, and convenient for clinical promotion. The near-infrared light biostimulation effect can enhance the activity of various enzymes, inhibit inflammatory cells, inhibit neuronal apoptosis, and promote nerve regeneration. It has been widely confirmed and widely used in the rehabilitation of central nervous system and peripheral nerve injury. However, the position of the spinal cord is deep, and the depth of illumination used by laser treatment equipment is generally difficult to reach.
The implantable 360° scattering fiber the investigators developed was implanted in the surgical site together with the drainage tube for irradiation treatment without additional patient damage.
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as acute spinal cord injury (ASIA grade A-C) (thoracic segment) requiring surgical laminectomy
- •The patient determined by the investigator to be eligible for the illuminating fiber implanted in this clinical trial
- •The patient fully understands the content and requirements of this clinical trial and is able to complete the follow-up according to the time specified in the protocol
- •Voluntary participation in clinical validation and signing informed consent
排除标准
- •The patient has a systemic infection or a local infection at the target surgical site
- •The patient has more than 2 segments of spinal cord injury, and the vital signs are unstable
- •A patient with a malignant tumor that does not involve the target surgical site
- •Patient life expectancy is less than one year
- •Pregnant or lactating women
- •The patient is too obese, BMI ≥ 40
- •Patients with other systemic diseases who are using corticosteroids, or patients with growth factors, or long-term use of non-steroidal anti-inflammatory drugs
- •Patients have a history of endocrine diseases affecting bone metabolism (such as diabetes, metabolic bone disease, etc.) or autoimmune diseases (such as multiple sclerosis)
- •Alcohol abuse within one year (average daily alcohol consumption > 40g, equivalent to 50ml alcohol 50ml, or smoking ≥ 40 / day, or drug abusers)
- •Participating in other drug or device clinical trials
研究组 & 干预措施
Laminectomy
干预措施: Laminectomy (Procedure)
Laminectomy & Irradiation
干预措施: Laminectomy (Procedure)
Laminectomy & Irradiation
干预措施: Spinal nerve laser therapeutic apparatus（Composed of 808-band fully automatic control laser device and implantable 360° scattering medical fiber） (Device)
结局指标
主要结局
Change from Baseline ASIA Rating Scale at 6 Months
时间窗: 6 Months
The ASIA rating scale was used to evaluate the patient's function, and the scores of each major item were obtained according to the weighting factors of each major item, with a total score of 0 to 100 points.
Change from Baseline ASIA Rating Scale at 12 Months
时间窗: 12 Months
The ASIA rating scale was used to evaluate the patient's function, and the scores of each major item were obtained according to the weighting factors of each major item, with a total score of 0 to 100 points.
Change from Baseline EMG at 6 Months
时间窗: 6 Months
The motor evoked potentials（MEP) and sensory evoked potentials(SEP) were evaluated, and the differences in the latency of the evoked potential N1 wave between the two groups were compared.
Change from Baseline EMG at 12 Months
时间窗: 12 Months
The motor evoked potentials（MEP) and sensory evoked potentials(SEP) were evaluated, and the differences in the latency of the evoked potential N1 wave between the two groups were compared.
次要结局
未报告次要终点