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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03643419
Recruitment Status : Unknown
Verified August 2018 by Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Photobiology Neurological Rehabilitation Near Infrared Light Irradiation Procedure: Laminectomy Device: Spinal nerve laser therapeutic apparatus（Composed of 808-band fully automatic control laser device and implantable 360° scattering medical fiber） Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Treatment of Acute Spinal Cord Injury by Near Infrared Light Irradiation
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: Laminectomy Procedure: Laminectomy
According to the standard procedure of laminectomy for acute spinal cord injury
Experimental: Laminectomy & Irradiation Procedure: Laminectomy
According to the standard procedure of laminectomy for acute spinal cord injury

Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline ASIA Rating Scale at 6 Months [ Time Frame: 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.

  2. Change from Baseline ASIA Rating Scale at 12 Months [ Time Frame: 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.

  3. Change from Baseline EMG at 6 Months [ Time Frame: 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.

  4. Change from Baseline EMG at 12 Months [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03643419


Contacts
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Contact: Tan Ding +86 13992825000 xijing_lllt@163.com

Locations
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China, Shaanxi
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 075100
Contact: Tan Ding         
Sponsors and Collaborators
Xijing Hospital
Investigators
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Study Director: Wang Xijing Hospital
More Information
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Publications:

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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT03643419    
Other Study ID Numbers: KY20172036-1
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System