Ischemic StrokeNCT06932627
Effects of Intravascular Laser Irradiation of Blood for Mitochondral Dysfunction in Cerebral Ischemic Stroke
A study testing ILIB in people with Ischemic Stroke, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
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 research will further explore the changes of mitochondria function after treatment. 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?
- ILIB
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2023to 31 Dec 2024
- 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
- 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: Effects of Intravascular Laser Irradiation of Blood for Mitochondral Dysfunction and Oxidative Stress in Adults With Chronic Cerebral Ischemic Stroke
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 research will further explore the changes of mitochondria function after treatment. 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 and platelet activity after intravenous laser irradiation of blood for ischemic stroke patient. Furthermore, to establish a new way of clinical 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 5Mw, 30 minutes each time, once everyother day for 3 days each week, for 2 weeks (total 6 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 peripheralvenous 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.
- Conditions
- Ischemic Stroke
- Being tested
- ILIB, Sham Control
- Keywords
- Ischemic Stroke, intravenous laser irradiation of blood, mitochondria activity
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILIBProcedure or surgery
The treatment group receive an intravenous 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 5 Mw, 30 minutes each time,once every other day for 3 consecutive days each week, for 2 weeks (total 6 times in one course)
Sham ControlProcedure or surgery
The steps for the control group are the same as the treatment group, exceptthat the output power is adjusted to zero intensity.
| Study group | Role | What they receive |
|---|---|---|
| ILIB therapy | 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 5 Mw, 30 minutes each time, once everyother day for 3 consecutive days each week, for 2 weeks (total 6 times in one course) Receives: Procedure: ILIB |
| sham control | 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: Procedure: Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Institutes of Health Stroke Scale (NIHSS)
NIHSS is a measure of the severity of symptoms associated with ischemic strokeand is used as a quantitative measure of neurological deficit post stroke. NIHSSscore is composed of 11 items, including consciousness, eye movement, visualfields, muscle power of four limbs, limbs ataxia, sensation, language, dysarthria andextinction. 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 higherscore is indicative of some level of impairment. Total score are between 0-42.
Measure before intravenous laser irradiation, three days, one month, and threemonths after the therapy.
Measured: 3 month
Secondary outcomes (1)
Modified Rankin Scale (mRS)
The Modified Rankin Scale (mRS) is used to measure the degree of disability ordependence in the daily activities in patients who have had a stroke 0: Nosymptoms at all
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start1 Aug 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 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)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932627
- Sponsor's protocol ID
- TSGH-D-111109
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- 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 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intravascular Laser Irradiation of Blood for Mitochondral Dysfunction and Oxidative Stress in Adults With Chronic Cerebral Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06932627
- Acronym / sponsor ID
- TSGH-D-111109
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic Stroke, intravenous laser irradiation of blood, mitochondria activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 17 Apr 2025 (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.
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 research will further explore the changes of mitochondria function after treatment. 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 and platelet activity after intravenous laser irradiation of blood for ischemic stroke patient. Furthermore, to establish a new way of clinical 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 5Mw, 30 minutes each time, once everyother day for 3 days each week, for 2 weeks (total 6 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 peripheralvenous 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ILIB therapy | Experimental | Procedure: ILIBThe 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 5 Mw, 30 minutes each time, once everyother day for 3 consecutive days each week, for 2 weeks (total 6 times in one course) |
| sham control | Sham comparator | Procedure: Sham ControlThe 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 |
|---|---|---|
| ILIBThe treatment group receive an intravenous 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 5 Mw, 30 minutes each time,once every other day for 3 consecutive days each week, for 2 weeks (total 6 times in one course) | Procedure or surgery | ILIB therapy |
| Sham ControlThe steps for the control group are the same as the treatment group, exceptthat the output power is adjusted to zero intensity. | Procedure or surgery | sham control |
Primary outcome
National Institutes of Health Stroke Scale (NIHSS)
Time frame: 3 month
NIHSS is a measure of the severity of symptoms associated with ischemic strokeand is used as a quantitative measure of neurological deficit post stroke. NIHSSscore is composed of 11 items, including consciousness, eye movement, visualfields, muscle power of four limbs, limbs ataxia, sensation, language, dysarthria andextinction. 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 higherscore is indicative of some level of impairment. Total score are between 0-42. Measure before intravenous laser irradiation, three days, one month, and threemonths after the therapy.
1 secondary outcome
Modified Rankin Scale (mRS)
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ILIB 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 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
National Institutes of Health Stroke Scale (NIHSS) (time frame: 3 month). 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 Apr 2025.