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

NCT03643419 | Unknown

• 1 other identifier: KY20172036-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Photobiology; Neurological Rehabilitation; Near Infrared Light Irradiation

Outcome Measures

Primary Outcomes (4)

• 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.

  6 Months

• 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.

  12 Months

• 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.

  6 Months

• 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.

  12 Months

Study Arms (2)

Laminectomy

SHAM COMPARATOR

Procedure: Laminectomy

Laminectomy & Irradiation

EXPERIMENTAL

Procedure: Laminectomy; Device: Spinal nerve laser therapeutic apparatus（Composed of 808-band fully automatic control laser device and implantable 360° scattering medical fiber）

Interventions

Laminectomy PROCEDURE

According to the standard procedure of laminectomy for acute spinal cord injury

Laminectomy; Laminectomy & Irradiation

Spinal nerve laser therapeutic apparatus（Composed of 808-band fully automatic control laser device and implantable 360° scattering medical fiber） DEVICE

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.

Laminectomy & Irradiation

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 075100, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 11805601 BACKGROUND

• 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.

  PMID: 26030745 BACKGROUND

• 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.

  PMID: 27460512 BACKGROUND

• 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.

  PMID: 24594641 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Laminectomy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Decompression, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Wang

  Xijing Hospital

  STUDY DIRECTOR

Central Study Contacts

Tan Ding

CONTACT

+86 13992825000; xijing_lllt@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 22, 2018
• Study Start: September 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: December 30, 2019
• Last Updated: August 22, 2018

Record last verified: 2018-08

Locations

CN (1)