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

August 20, 2018 updated by: Xijing Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 075100
        • Recruiting
        • Xijing Hospital
        • Contact:
          • Tan Ding

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 Months
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.
12 Months
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.
6 Months
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.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Study Director: Wang, Xijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2018

Primary Completion (ANTICIPATED)

June 30, 2019

Study Completion (ANTICIPATED)

December 30, 2019

Study Registration Dates

First Submitted

August 16, 2018

First Submitted That Met QC Criteria

August 20, 2018

First Posted (ACTUAL)

August 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 22, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20172036-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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