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

Primary Purpose

Spinal Cord Injuries, Photobiology, Neurological Rehabilitation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laminectomy
Spinal nerve laser therapeutic apparatus（Composed of 808-band fully automatic control laser device and implantable 360° scattering medical fiber）
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Xijing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Laminectomy

Laminectomy & Irradiation

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 16, 2018
Last Updated
August 20, 2018
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03643419
Brief Title
Clinical Study of Treatment of Acute Spinal Cord Injury by Near Infrared Light Irradiation
Official Title
Clinical Study of Treatment of Acute Spinal Cord Injury by Near Infrared Light Irradiation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Anticipated)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Photobiology, Neurological Rehabilitation, Near Infrared Light Irradiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laminectomy
Arm Type
Sham Comparator
Arm Title
Laminectomy & Irradiation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Laminectomy
Intervention Description
According to the standard procedure of laminectomy for acute spinal cord injury
Intervention Type
Device
Intervention Name(s)
Spinal nerve laser therapeutic apparatus（Composed of 808-band fully automatic control laser device and implantable 360° scattering medical fiber）
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline ASIA Rating Scale at 6 Months
Description
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.
Time Frame
6 Months
Title
Change from Baseline ASIA Rating Scale at 12 Months
Description
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.
Time Frame
12 Months
Title
Change from Baseline EMG at 6 Months
Description
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.
Time Frame
6 Months
Title
Change from Baseline EMG at 12 Months
Description
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.
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tan Ding
Phone
+86 13992825000
Email
xijing_lllt@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang
Organizational Affiliation
Xijing Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
075100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tan Ding

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
11805601
Citation
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.
Results Reference
background
PubMed Identifier
26030745
Citation
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.
Results Reference
background
PubMed Identifier
27460512
Citation
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.
Results Reference
background
PubMed Identifier
24594641
Citation
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.
Results Reference
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Clinical Study of Treatment of Acute Spinal Cord Injury by Near Infrared Light Irradiation

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