Low-Level Laser TherapyNCT03724799
Therapeutic Effect of Intravascular Laser Irradiation of Blood
A study testing Intravascular laser irradiation of blood for the patients with cerebral infarction in people with Low-Level Laser Therapy, run by Tri-Service General Hospital (TSGH).
Trial summary
The investigators' previous studies results showed that the non-invasive treatment effects of low-energy lasers with the period of 5 consecutive days, could significantly improve the local function of static and dynamic motion stability of the lower extremities (p<0.0001) among the participants with lower limb… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Low-Level Laser Therapy
- What is being tested?
- Intravascular laser irradiation of blood for the patients with cerebral infarction
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 14 Nov 2018to 30 Sep 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent that is consistent with ICH-GCP guidelines(The International Conference on Harmonisation's Guideline for Good Clinical Practice).
- Age ≥ 18 years and ≤80 years of age.
- Body weight ≥40 kg
- Written informed consent that is consistent with ICH-GCP guidelines.
- Age ≥ 18 years and ≤80 years of age. Substantial unilateral motor impairment
- At least 6 months post thromboembolic ischemic stroke in subcortical region of MCA or lenticulostriate artery with or without cortical involvement.
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- Between 6 and 24 months post-stroke, and having a motor or sensory neurological deficit
- No significant further improvement with physical therapy/rehabilitation
- Able and willing to undergo computed tomography (CT), magnetic resonance imaging (MRI), and single photon emission tomography (SPECT) scans of the head
Who cannot join
- Subjects with cranial metallic implants, cardiac pacemakers or claustrophobia.
- Previous diagnosis of stroke or dementia
- Significant history of depression
- History of symptomatic stroke
- History of seizures
- History or presence of any other major neurological disease
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- Myocardial infarction within prior 6 months.
- Known presence of any malignancy
- Patients with bleeding tendency or coagulation profile abnormalities
- Have a serious infection or other serious medical illness that requires treatment and/or hospitalization within 90 days before study entry.
- Have received any of the following within 6 months of study entry: systemic corticosteroids; chemotherapy or radiation; erythropoietin, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), or growth hormone; drugs that affect the immune system including thalidomide, interleukins, interferons, or other cytokines; anabolic steroids at high levels; or any experimental agent, unless allowed otherwise by the researchers.
- Participation in any other investigational trial within 4 weeks of initial screening and within 7 weeks of study entry
- Contraindications to head CT, MRI, or SPECT
- Pregnant or lactating
- Botox treatment to the involved arm within three months of enrollment
- Subjects with conscious disturbance or moderate to severe aphasia
- Stroke group:
- History of more than 1 symptomatic stroke
- History of seizures
- History or presence of any other major neurological disease
- Myocardial infarction within prior 6 months.
- Known presence of any malignancy
- Patients with bleeding tendency or coagulation profile abnormalities
- Have a serious infection or other serious medical illness that requires treatment and/or hospitalization within 90 days before study entry.
- Have received any of the following within 6 months of study entry: systemic corticosteroids; chemotherapy or radiation; erythropoietin, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), or growth hormone; drugs that affect the immune system including thalidomide, interleukins, interferons, or other cytokines; anabolic steroids at high levels; or any experimental agent, unless allowed otherwise by the researchers.
- Participation in any other investigational trial within 4 weeks of initial screening and within 7 weeks of study entry
- Contraindications to head CT, MRI, or SPECT
- Pregnant or lactating
- Botox treatment to the involved arm within three months of enrollment
- Subjects with conscious disturbance or moderate to severe aphasia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Investigation of Therapeutic Effect and Molecular Mechanism After Intravascular Laser Irradiation of Blood
The investigators' previous studies results showed that the non-invasive treatment effects of low-energy lasers with the period of 5 consecutive days, could significantly improve the local function of static and dynamic motion stability of the lower extremities (p<0.0001) among the participants with lower limb periostitis. Therefore, investigators would like to further understand the treatment effect of intravascular low-energy laser on the central nervous system disorders. It is hoped that with this study, investigators can better understand how to use intravenous laser therapy to help those participants improve their ability of self-care and functional recovery.
- Conditions
- Low-Level Laser Therapy
- Being tested
- Intravascular laser irradiation of blood for the patients with cerebral infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular laser irradiation of blood for the patients with cerebral infarctionDevice
Intravenous low level therapy has been a variety of applications in many different areas of medicine with a growing interest. It possesses laser specific biomodulation, analgesic, spasmolytic and even sedative effects among many other.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Intravenous low level laser therapy Receives: Device: Intravascular laser irradiation of blood for the patients with cerebral infarction |
What is being measured
The primary outcome is the main question the study is designed to answer.
microcirculatory function of the skin
Laser Doppler Flowmetry is reliable for assessing microcirculatory status.
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start14 Nov 2018 (estimated)
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low-Level Laser TherapyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng-Chiang Chang, Tri-Service General Hospital (TSGH)
- Investigators
- Cheng-Chiang Chang, MD. PhD., Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724799
- Sponsor's protocol ID
- MOST 107-2314-B-016-074 -
- Status last verified
- Nov 2018
- First submitted
- 28 Oct 2018
- Last updated
- 16 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of Therapeutic Effect and Molecular Mechanism After Intravascular Laser Irradiation of Blood
- ClinicalTrials.gov ID
- NCT03724799
- Acronym / sponsor ID
- MOST 107-2314-B-016-074 -
- Conditions
- Low-Level Laser Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 14 Nov 2018 (estimated)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 30 Oct 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 investigators' previous studies results showed that the non-invasive treatment effects of low-energy lasers with the period of 5 consecutive days, could significantly improve the local function of static and dynamic motion stability of the lower extremities (p<0.0001) among the participants with lower limb periostitis. Therefore, investigators would like to further understand the treatment effect of intravascular low-energy laser on the central nervous system disorders. It is hoped that with this study, investigators can better understand how to use intravenous laser therapy to help those participants improve their ability of self-care and functional recovery.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Device: Intravascular laser irradiation of blood for the patients with cerebral infarctionIntravenous low level laser therapy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent that is consistent with ICH-GCP guidelines(The International Conference on Harmonisation's Guideline for Good Clinical Practice).
- Age ≥ 18 years and ≤80 years of age.
- Body weight ≥40 kg
- Written informed consent that is consistent with ICH-GCP guidelines.
- Age ≥ 18 years and ≤80 years of age. Substantial unilateral motor impairment
Key exclusion criteria (30 listed)
- Subjects with cranial metallic implants, cardiac pacemakers or claustrophobia.
- Previous diagnosis of stroke or dementia
- Significant history of depression
- History of symptomatic stroke
- History of seizures
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 |
|---|---|---|
| Intravascular laser irradiation of blood for the patients with cerebral infarctionIntravenous low level therapy has been a variety of applications in many different areas of medicine with a growing interest. It possesses laser specific biomodulation, analgesic, spasmolytic and even sedative effects among many other. | Device | single arm |
Primary outcome
microcirculatory function of the skin
Time frame: 12 days
Laser Doppler Flowmetry is reliable for assessing microcirculatory status.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Cheng-Chiang Chang, MD. PhD. principal investigator
Tri-Service General Hospital (TSGH)
Questions about this trial
What is this clinical trial studying?
A study testing Intravascular laser irradiation of blood for the patients with cerebral infarction in people with Low-Level Laser Therapy, run by Tri-Service General Hospital (TSGH).
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 9 inclusion and 30 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 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Cheng-Chiang Chang, MD. PhD. (886-2- 87923311 ext. 13782, doc31146@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microcirculatory function of the skin (time frame: 12 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2018.