Clinical Study of Treatment of Acute Spinal Cord Injury by Near Infrared Light Irradiation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Study of Treatment of Acute Spinal Cord Injury by Near Infrared Light Irradiation

Conditions
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Spinal Cord Injuries, Photobiology, Neurological Rehabilitation, Near Infrared Light Irradiation

Intervention / Treatment
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* Procedure: Laminectomy
* Device: Spinal nerve laser therapeutic apparatus（Composed of 808-band fully automatic control laser device and implantable 360° scattering medical fiber）


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Laminectomy<br> | Procedure: Laminectomy<br>* According to the standard procedure of laminectomy for acute spinal cord injury<br>|
| Experimental: Laminectomy & Irradiation<br> | Procedure: Laminectomy<br>* According to the standard procedure of laminectomy for acute spinal cord injury<br>Device: Spinal nerve laser therapeutic apparatus（Composed of 808-band fully automatic control laser device and implantable 360° scattering medical fiber）<br>* According to the standard procedure of decompression of laminectomy for acute spinal cord injury, the patient in the Near Infrared Light Irradiation Group placed the implantable 360° scattering fiber laterally above the operation area at the end of the operation. Near infrared light irradiation is applied by spinal nerve laser therapeutic apparatus every day from the day after surgery, once a day for 60 minutes each time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline ASIA Rating Scale at 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. | 6 Months | 
| Change from Baseline ASIA Rating Scale at 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. | 12 Months | 
| Change from Baseline EMG at 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. | 6 Months | 
| Change from Baseline EMG at 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. | 12 Months |