Clinical Study of Treatment of Acute Spinal Cord Injury by Near Infrared Light Irradiation
NCT ID: NCT03643419
Last Updated: 2018-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2018-09-01
2019-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Laminectomy
Laminectomy
According to the standard procedure of laminectomy for acute spinal cord injury
Laminectomy & Irradiation
Laminectomy
According to the standard procedure of laminectomy for acute spinal cord injury
Spinal nerve laser therapeutic apparatus（Composed of 808-band fully automatic control laser device and implantable 360° scattering medical fiber）
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.
Interventions
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Laminectomy
According to the standard procedure of laminectomy for acute spinal cord injury
Spinal nerve laser therapeutic apparatus（Composed of 808-band fully automatic control laser device and implantable 360° scattering medical fiber）
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
70 Years
ALL
No
Sponsors
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Xijing Hospital
OTHER
Responsible Party
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Principal Investigators
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Wang
Role: STUDY_DIRECTOR
Xijing Hospital
Locations
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Xijing Hospital
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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Tan Ding
Role: primary
References
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Sekhon LH, Fehlings MG. Epidemiology, demographics, and pathophysiology of acute spinal cord injury. Spine (Phila Pa 1976). 2001 Dec 15;26(24 Suppl):S2-12. doi: 10.1097/00007632-200112151-00002.
Khan I, Tang E, Arany P. Molecular pathway of near-infrared laser phototoxicity involves ATF-4 orchestrated ER stress. Sci Rep. 2015 Jun 1;5:10581. doi: 10.1038/srep10581.
Black B, Vishwakarma V, Dhakal K, Bhattarai S, Pradhan P, Jain A, Kim YT, Mohanty S. Spatial temperature gradients guide axonal outgrowth. Sci Rep. 2016 Jul 27;6:29876. doi: 10.1038/srep29876.
Chen YJ, Wang YH, Wang CZ, Ho ML, Kuo PL, Huang MH, Chen CH. Effect of low level laser therapy on chronic compression of the dorsal root ganglion. PLoS One. 2014 Mar 4;9(3):e89894. doi: 10.1371/journal.pone.0089894. eCollection 2014.
Other Identifiers
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KY20172036-1
Identifier Type: -
Identifier Source: org_study_id
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