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Trial record 1 of 33 for:    spinal cord injury | radiation
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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

Tracking Information
First Submitted Date  ICMJE August 16, 2018
First Posted Date  ICMJE August 22, 2018
Last Update Posted Date August 22, 2018
Estimated Study Start Date  ICMJE September 1, 2018
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study of Treatment of Acute Spinal Cord Injury by Near Infrared Light Irradiation
Official Title  ICMJE Clinical Study of Treatment of Acute Spinal Cord Injury by Near Infrared Light Irradiation
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Cord Injuries
  • Photobiology
  • Neurological Rehabilitation
  • Near Infrared Light Irradiation
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Sham Comparator: Laminectomy
    Intervention: Procedure: Laminectomy
  • Experimental: Laminectomy & Irradiation
    Interventions:
    • Procedure: Laminectomy
    • Device: Spinal nerve laser therapeutic apparatus(Composed of 808-band fully automatic control laser device and implantable 360° scattering medical fiber)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 20, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03643419
Other Study ID Numbers  ICMJE KY20172036-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Xijing Hospital
Study Sponsor  ICMJE Xijing Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wang Xijing Hospital
PRS Account Xijing Hospital
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP