Ischemic StrokeNCT05456750
the Investigation of Therapeutic Effect After ILIB for Ischemic Stroke Patient
A study testing Intravascular laser irradiation of blood in people with Ischemic Stroke, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
The aim of our study is to therapeutic effect after intravenous laser irradiation of blood for ischemic stroke patient Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Intravascular laser irradiation of blood
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Jul 2022to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 20 to 80 years old
- Able to speak and understand Mandarin/Taiwanese
- No cognitive impairment
- Residual motor function impairment (mRS>1)
- Mild stroke (NIHSS=1-4) or Moderate stroke(NIHSS=5-15)
- No psychological disease
Who cannot join
- Severe stroke (NIHSS=16-42)
- History of intracerebral hemorrhage and other major surgery
- History of malignancy, chronic kidney disease
- Active infection
- Chronic hepatitis B or Chronic hepatitis C
- Unstable angina or acute myocardial infarction within 6 months
- Severe cognition impairment
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Investigation of Therapeutic Effect After Intravenous Laser Irradiation of Blood for Ischemic Stroke Patient
The aim of our study is to therapeutic effect after intravenous laser irradiation of blood for ischemic stroke patient
Read the detailed description
Background : This research is designed through randomization, control, and double-blind trial to explore the clinical effectiveness of intravenous laser irradiation of blood for ischemic stroke patient; The light accelerates blood and cells circulation in the human body, so that protein molecular structure would promote changes. Pain control is indicated in such treatment, but still lacking evidence of neurological symptoms and functional improvement.
Purpose:This research is designed through randomization, control, and double-blind trial to therapeutic effect after intravenous laser irradiation of blood for ischemic stroke patient. Furthermore, to establish a new way of clinical rehabilitation therapy.
Method: The investigators plan to recruit 20 patients who are between the ages of 20 to 80 years old. The participants are required to have clear conscious and be able to communicate. The patient with mild to moderate stroke ( NIHSS=1-15), which onset between one month to 2 years will be included. The treatment group will receive an intravenous helium-neon laser phototherapy. A vein indwelling needle will be placed in their veins located in the upper elbow, and the laser fiber catheter will be introduced through the indwelling cannula. The power is set between 2.5 ~ 3.0Mw, 60 minutes each time, once a day for five consecutive days each week, for 2 weeks (total 10 times in one course). The steps for the control group are the same, except that the output power is adjusted to zero intensity. This plan will be explained to the patient in detail during the outpatient visit and patients will sign the consent form upon agreement. Before intravenous laser irradiation, three days, one month, and three months after the therapy, 20 ml of autologous peripheral venous blood need to be drawn for basic blood tests and platelet activity tests. At the same time, the clinical functions of patients will be evaluated, including NIHSS, mRS and Stroke Impact Scale (SIS).
- Conditions
- Ischemic Stroke
- Being tested
- Intravascular laser irradiation of blood
- Keywords
- Ischemic Stroke, intravenous laser irradiation of blood
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular laser irradiation of bloodDevice
Low intensity intravenous laser irradiation of blood phototherapy is a method of a 632.8 nm red light penetrate into a vein through fiber and the brightness is 100 fold of the sun. The light accelerates blood and cells circulation in the human body, so that protein molecular structure would promote changes.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | The treatment group receive an intravenous helium-neon laser phototherapy. A vein indwelling needle will be placed in their veins located in the upper elbow, and the laser fiber catheter will be introduced through the indwelling cannula. The laser power is set between 2.5 ~ 3.0Mw, 60 minutes each time, once a day for five consecutive days each week, for 2 weeks (total 10 times in one course) Receives: Device: Intravascular laser irradiation of blood |
| control group | Sham comparator | The steps for the control group are the same as the treatment group, except that the output power is adjusted to zero intensity. Receives: Device: Intravascular laser irradiation of blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (mRS)
The Modified Rankin Scale (mRS) is used to measure the degree of disability or dependence in the daily activities in patients who have had a stroke 0: No symptoms at all
- No significant disability despite symptoms; able to carry out all usual duties and activities
- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
- Moderate disability; requiring some help, but able to walk without assistance
- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
- Severe disability; bedridden, incontinent and requiring constant nursing care and attention
- Dead Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.
Measured: 3 months post therapy at 3.5 months
Secondary outcomes (4)
National Institutes of Health Stroke Scale (NIHSS)
NIHSS is a measure of the severity of symptoms associated with ischemic stroke and is used as a quantitative measure of neurological deficit post stroke. NIHSS score is composed of 11 items, including consciousness, eye movement, visual fields, muscle power of four limbs, limbs ataxia, sensation, language, dysarthria and extinction. Each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. Total score are between 0-42.
Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.
Measured: 3 months post therapy at 3.5 months
Stroke Impact Scale(SIS)
The Stroke Impact Scale (SIS) is a newly developed comprehensive outcome measure consists of items measuring 8 domains- strength (0-20), hand function (0-25), activities of daily living (ADL) and instrumental ADL (0-50), mobility (0-45), communication (0-35), emotion (0-45), memory and thinking (0-35), and participation (0-40). It was based on feedback from patients and their caregivers. The total score is 0-295. The higher scores indicating better function or less impact from stroke.
Measured: 3 months post therapy at 3.5 months
The Fugl-Meyer Assessment-Motor Function
The Fugl-Meyer Assessment - Motor Function (FMA-MF) subscale evaluates movement, reflexes, and coordination of the upper and lower extremities post-stroke. It is widely used as a standardized measure of motor recovery.Upper extremity subscale: 33 items, maximum score = 66.Lower extremity subscale: 17 items, maximum score = 34.
Total motor domain score: Sum of upper and lower extremity subscales, maximum score = 100. Higher scores indicate better motor function and less impairment. Reported values in this study represent the total motor domain score (0-100).
Measured: 3 months post therapy at 3.5 months
The 6-minute Walk Test
is a widely used functional evaluation tool that quantifies the distance an individual can walk over a flat surface within 6 minutes.
Measured: 3 months post therapy at 3.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start28 Jul 2022
- Primary completion31 Jul 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ischemic StrokeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang-Cheng Chen, Tri-Service General Hospital (TSGH)
- Investigators
- Liang-Cheng Chen, MD,MS, Principal investigator, Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456750
- Sponsor's protocol ID
- TSGH-D-111106
- Status last verified
- Feb 2026
- First submitted
- 9 Jul 2022
- Last updated
- 17 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of Therapeutic Effect After Intravenous Laser Irradiation of Blood for Ischemic Stroke Patient
- ClinicalTrials.gov ID
- NCT05456750
- Acronym / sponsor ID
- TSGH-D-111106
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic Stroke, intravenous laser irradiation of blood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Posted 17 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of our study is to therapeutic effect after intravenous laser irradiation of blood for ischemic stroke patient
Detailed description
Background : This research is designed through randomization, control, and double-blind trial to explore the clinical effectiveness of intravenous laser irradiation of blood for ischemic stroke patient; The light accelerates blood and cells circulation in the human body, so that protein molecular structure would promote changes. Pain control is indicated in such treatment, but still lacking evidence of neurological symptoms and functional improvement.
Purpose:This research is designed through randomization, control, and double-blind trial to therapeutic effect after intravenous laser irradiation of blood for ischemic stroke patient. Furthermore, to establish a new way of clinical rehabilitation therapy.
Method: The investigators plan to recruit 20 patients who are between the ages of 20 to 80 years old. The participants are required to have clear conscious and be able to communicate. The patient with mild to moderate stroke ( NIHSS=1-15), which onset between one month to 2 years will be included. The treatment group will receive an intravenous helium-neon laser phototherapy. A vein indwelling needle will be placed in their veins located in the upper elbow, and the laser fiber catheter will be introduced through the indwelling cannula. The power is set between 2.5 ~ 3.0Mw, 60 minutes each time, once a day for five consecutive days each week, for 2 weeks (total 10 times in one course). The steps for the control group are the same, except that the output power is adjusted to zero intensity. This plan will be explained to the patient in detail during the outpatient visit and patients will sign the consent form upon agreement. Before intravenous laser irradiation, three days, one month, and three months after the therapy, 20 ml of autologous peripheral venous blood need to be drawn for basic blood tests and platelet activity tests. At the same time, the clinical functions of patients will be evaluated, including NIHSS, mRS and Stroke Impact Scale (SIS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Device: Intravascular laser irradiation of bloodThe treatment group receive an intravenous helium-neon laser phototherapy. A vein indwelling needle will be placed in their veins located in the upper elbow, and the laser fiber catheter will be introduced through the indwelling cannula. The laser power is set between 2.5 ~ 3.0Mw, 60 minutes each time, once a day for five consecutive days each week, for 2 weeks (total 10 times in one course) |
| control group | Sham comparator | Device: Intravascular laser irradiation of bloodThe steps for the control group are the same as the treatment group, except that the output power is adjusted to zero intensity. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 20 to 80 years old
- Able to speak and understand Mandarin/Taiwanese
- No cognitive impairment
- Residual motor function impairment (mRS>1)
- Mild stroke (NIHSS=1-4) or Moderate stroke(NIHSS=5-15)
Key exclusion criteria (8 listed)
- Severe stroke (NIHSS=16-42)
- History of intracerebral hemorrhage and other major surgery
- History of malignancy, chronic kidney disease
- Active infection
- Chronic hepatitis B or Chronic hepatitis C
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 bloodLow intensity intravenous laser irradiation of blood phototherapy is a method of a 632.8 nm red light penetrate into a vein through fiber and the brightness is 100 fold of the sun. The light accelerates blood and cells circulation in the human body, so that protein molecular structure would promote changes. | Device | control group, treatment group |
Primary outcome
Modified Rankin Scale (mRS)
Time frame: 3 months post therapy at 3.5 months
The Modified Rankin Scale (mRS) is used to measure the degree of disability or dependence in the daily activities in patients who have had a stroke 0: No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.
4 secondary outcomes
National Institutes of Health Stroke Scale (NIHSS)
Time frame: 3 months post therapy at 3.5 months
Stroke Impact Scale(SIS)
Time frame: 3 months post therapy at 3.5 months
The Fugl-Meyer Assessment-Motor Function
Time frame: 3 months post therapy at 3.5 months
The 6-minute Walk Test
Time frame: 3 months post therapy at 3.5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Ischemic Stroke
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Recruiting
Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.
Stroke, Implantation of an Implantable Cardiac Monitor
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
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.
Liang-Cheng Chen, MD,MS principal investigator
Department of Physical Medicine and Rehabilitation, Tri-Service General 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 Intravascular laser irradiation of blood in people with Ischemic Stroke, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 17 Jun 2026. 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 Taiwan. 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?
Yes. Results are posted in the registry (first posted 17 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (mRS) (time frame: 3 months post therapy at 3.5 months). 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 17 Jun 2026.