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

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Neurological Rehabilitation; Spinal Cord Injuries; Near Infrared Light Irradiation; Photobiology

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03643419

KY20172036-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Laminectomy

Sham Comparator group

Treatment:

Procedure: Laminectomy

Laminectomy & Irradiation

Experimental group

Treatment:

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

Procedure: Laminectomy