Spinal Cord InjuriesNCT03643419
Clinical Study of Treatment of Acute Spinal Cord Injury by Near Infrared Light Irradiation
A study testing Laminectomy in people with Spinal Cord Injuries and Photobiology, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Spinal Cord Injuries, Photobiology, Neurological Rehabilitation
- What is being tested?
- Laminectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 075100
Tan Ding
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Photobiology, Neurological Rehabilitation, Near Infrared Light Irradiation
- Being tested
- Laminectomy, Spinal nerve laser therapeutic apparatus（Composed of 808-band fully automatic control laser device and implantable 360° scattering medical fiber）
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaminectomyProcedure or surgery
According to the standard procedure of laminectomy for acute spinal cord injury
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.
| Study group | Role | What they receive |
|---|---|---|
| Laminectomy | Sham comparator | Not described Receives: Procedure: Laminectomy |
| Laminectomy & Irradiation | Experimental | Not described Receives: Procedure: Laminectomy; Device: Spinal nerve laser therapeutic apparatus（Composed of 808-band fully automatic control laser device and implantable 360° scattering medical fiber） |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang, Study director, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643419
- Sponsor's protocol ID
- KY20172036-1
- Status last verified
- Aug 2018
- First submitted
- 16 Aug 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 11805601Khan 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.
PubMed 26030745Black 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.
PubMed 27460512Chen 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.
PubMed 24594641
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Treatment of Acute Spinal Cord Injury by Near Infrared Light Irradiation
- ClinicalTrials.gov ID
- NCT03643419
- Acronym / sponsor ID
- KY20172036-1
- Conditions
- Spinal Cord Injuries, Photobiology, Neurological Rehabilitation, Near Infrared Light Irradiation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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） |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaminectomyAccording to the standard procedure of laminectomy for acute spinal cord injury | Procedure or surgery | Laminectomy, Laminectomy & Irradiation |
| 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. | Device | Laminectomy & Irradiation |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Background: PubMed 11805601Sekhon 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.
- Background: PubMed 26030745Khan 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.
- Background: PubMed 27460512Black 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.
- Background: PubMed 24594641Chen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wang study director
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laminectomy in people with Spinal Cord Injuries and Photobiology, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tan Ding (+86 13992825000, xijing_lllt@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline ASIA Rating Scale at 6 Months (time frame: 6 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03643419, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.