StrokeNCT06232499
Effects of Intravenous Laser Irradiation of Blood Treatment With Different Colored Lights on Controlling Recurrent Stroke Risk Factors and Neurological Function in Stroke Patients
A study testing Intravenous Laser Irradiation of Blood in people with Stroke, run by Taipei Hospital, Ministry of Health and Welfare at 1 site in Taiwan.
Trial summary
Introduction and Purpose: Patients with stroke have over a decade of experience with vascular laser treatment. Previous studies predominantly used low-energy vascular lasers with red light, specifically helium-neon lasers with a wavelength of 632.8nm. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Intravenous Laser Irradiation of Blood
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Jan 2024to 14 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as a first-time stroke patient.
- Onset of illness within 6 months of enrollment.
- Recruitment period from January to December of the year 113.
- All participants or their legal representatives must sign the informed consent form.
Who cannot join
- Skin diseases that make injection or photosensitivity unsuitable.
- Pregnancy and abnormal blood clotting function.
- Presence of a cardiac pacemaker.
- Inability to comply with the 5-month study plan.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Hospital, Ministry of Health and Welfare
New Taipei City, ROC, 24213
About this study
Official title: Effects of Intravenous Laser Irradiation of Blood Treatment With Different Colored Lights on Controlling Recurrent Stroke Risk Factors and Neurological Function in Stroke Patients: a Randomized, Cross-over Trial
Introduction and Purpose:
Patients with stroke have over a decade of experience with vascular laser treatment. Previous studies predominantly used low-energy vascular lasers with red light, specifically helium-neon lasers with a wavelength of 632.8nm. However, different colored lights are absorbed by cells in the body in varying proportions, leading to potentially different effects. Therefore, there is an interest in understanding the impact of other colored lights on stroke patients. To understand the practical effects of low-energy laser treatment with different colored lights on improving neurological function and controlling recurrent stroke risk factors.
Read more
Methods:
A randomized crossover trial will be conducted with a study population consisting of individuals aged 20 and above who have experienced their first stroke within the last 6 months. Exclusion criteria include patients with skin conditions unsuitable for injection or light exposure, those with light allergies, pregnant individuals, those with abnormal blood clotting function, those with implanted pacemakers, and individuals unable to comply with the 5-month study plan. Participants will undergo 10 sessions of infrared light and 10 sessions of blue light vascular laser treatment. Blood tests and neurological assessments will be conducted before each treatment session (10 irradiations) and at the end of the two-month washout period between the two different colored lights. Descriptive analysis and pair t-tests will be employed to compare baseline values between the two groups. Subsequently, repeated measures ANOVA will be used to analyze differences between the intervention group and the control group. The study will examine whether various influencing factors are associated with receiving vascular laser treatment with different colored lights.
- Conditions
- Stroke
- Being tested
- Intravenous Laser Irradiation of Blood
- Keywords
- Stroke, Intravenous Laser Irradiation of Blood, Recurrent stroke risk factors
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Laser Irradiation of BloodDevice
The different color lights for Intravenous Laser Irradiation of Blood are red light at 808nm and blue light at 415nm
| Study group | Role | What they receive |
|---|---|---|
| Red-Blue Arm | Experimental | Participants in this arm first receive 10 sessions of vascular laser treatment with red light, followed by a two-month washout period, and then receive 10 sessions of vascular laser treatment with blue light. Receives: Device: Intravenous Laser Irradiation of Blood |
| Blue-Red Arm | Experimental | Participants in this arm first receive 10 sessions of vascular laser treatment with blue light, followed by a two-month washout period, and then receive 10 sessions of vascular laser treatment with red light. Receives: Device: Intravenous Laser Irradiation of Blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood urea nitrogen (BUN) test
Can reveal whether your urea nitrogen levels are higher than normal, suggesting that your kidneys may not be working properly.
Measured: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Creatinine test
Measure of how well your kidneys are performing their job of filtering waste from your blood.
Measured: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Uric acid levels
Uric acid levels are typically 2.5-7.0 milligrams per deciliter (mg/dL) in males and 1.5-6.0 mg/dL in females. Low levels are rare, but high levels can lead to gout, kidney disease, and other health issues.
Measured: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Blood cholesterol
Indicates blood lipid control
Measured: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Blood triglycerides
Indicates blood lipid control
Measured: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
High-Density Lipoprotein levels
Indicates blood lipid control
Measured: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Low-Density Lipoprotein levels
Indicates blood lipid control
Measured: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Blood Glucose after meal
Indicates blood glucose control
Measured: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Hemoglobin A1c levels
Indicates blood glucose control
Measured: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Complete Blood Count test
Indicates blood cell ratio control
Measured: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Blood Prothrombin Time
Indicates blood coagulation function control
Measured: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Activated Partial Thromboplastin Time levels
Indicates blood coagulation function control
Measured: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Blood Tumor Necrosis Factor-alpha levels
Indicates blood Inflammation control
Measured: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Blood Interleukin-6 levels
Indicates blood Inflammation control
Measured: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
High-sensitivity C-reactive Protein levels
Indicates blood Inflammation control
Measured: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Erythrocyte Sedimentation Rate levels
Indicates blood Inflammation control
Measured: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Modified Rankin Scale (MRS)
The Modified Rankin Scale is a scale that measures the degree of disability or dependence in daily activities following a neurological event, such as a stroke.
Measured: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Barthel Index and IADL (Instrumental Activities of Daily Living) Scores
Assesses a person's ability to perform basic activities of daily living (ADL), such as bathing, dressing, and feeding. Instrumental Activities of Daily Living extends the assessment to more complex activities, including managing finances and using transportation.
Measured: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
MMSE (Mini-Mental State Examination) Score
MMSE is a widely used screening tool for cognitive impairment. It evaluates various cognitive functions, including orientation, memory, and language. Changes in MMSE scores may indicate alterations in cognitive abilities, providing insights into the impact of interventions on cognitive function.
Measured: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Berg Balance Test Score
The Berg Balance Test assesses a person's balance and risk of falling. It includes tasks such as standing on one foot and turning around. Changes in Berg Balance Test scores can indicate improvements or declines in balance and stability.
Measured: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Fugl-Meyer Assessment Score
The Fugl-Meyer Assessment is commonly used to evaluate motor recovery after stroke.
It assesses motor function, balance, and sensation. Changes in Fugl-Meyer scores can indicate improvements or declines in motor function and overall recovery.
Measured: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start10 Jan 2024
- Primary completion14 Dec 2024
- Study completion14 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Hospital, Ministry of Health and Welfare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232499
- Sponsor's protocol ID
- 202406
- Status last verified
- Apr 2025
- First submitted
- 4 Jan 2024
- Last updated
- 9 Apr 2025
- 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 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intravenous Laser Irradiation of Blood Treatment With Different Colored Lights on Controlling Recurrent Stroke Risk Factors and Neurological Function in Stroke Patients: a Randomized, Cross-over Trial
- ClinicalTrials.gov ID
- NCT06232499
- Acronym / sponsor ID
- 202406
- Conditions
- Stroke
- Keywords
- Stroke, Intravenous Laser Irradiation of Blood, Recurrent stroke risk factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Taipei Hospital, Ministry of Health and WelfareUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 14 Dec 2024 (actual)
- Study completion
- 14 Dec 2024 (actual)
- First posted
- 30 Jan 2024 (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.
Introduction and Purpose:
Patients with stroke have over a decade of experience with vascular laser treatment. Previous studies predominantly used low-energy vascular lasers with red light, specifically helium-neon lasers with a wavelength of 632.8nm. However, different colored lights are absorbed by cells in the body in varying proportions, leading to potentially different effects. Therefore, there is an interest in understanding the impact of other colored lights on stroke patients. To understand the practical effects of low-energy laser treatment with different colored lights on improving neurological function and controlling recurrent stroke risk factors.
Methods:
A randomized crossover trial will be conducted with a study population consisting of individuals aged 20 and above who have experienced their first stroke within the last 6 months. Exclusion criteria include patients with skin conditions unsuitable for injection or light exposure, those with light allergies, pregnant individuals, those with abnormal blood clotting function, those with implanted pacemakers, and individuals unable to comply with the 5-month study plan. Participants will undergo 10 sessions of infrared light and 10 sessions of blue light vascular laser treatment. Blood tests and neurological assessments will be conducted before each treatment session (10 irradiations) and at the end of the two-month washout period between the two different colored lights. Descriptive analysis and pair t-tests will be employed to compare baseline values between the two groups. Subsequently, repeated measures ANOVA will be used to analyze differences between the intervention group and the control group. The study will examine whether various influencing factors are associated with receiving vascular laser treatment with different colored lights.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red-Blue Arm | Experimental | Device: Intravenous Laser Irradiation of BloodParticipants in this arm first receive 10 sessions of vascular laser treatment with red light, followed by a two-month washout period, and then receive 10 sessions of vascular laser treatment with blue light. |
| Blue-Red Arm | Experimental | Device: Intravenous Laser Irradiation of BloodParticipants in this arm first receive 10 sessions of vascular laser treatment with blue light, followed by a two-month washout period, and then receive 10 sessions of vascular laser treatment with red light. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed as a first-time stroke patient.
- Onset of illness within 6 months of enrollment.
- Recruitment period from January to December of the year 113.
- All participants or their legal representatives must sign the informed consent form.
Key exclusion criteria (4 listed)
- Skin diseases that make injection or photosensitivity unsuitable.
- Pregnancy and abnormal blood clotting function.
- Presence of a cardiac pacemaker.
- Inability to comply with the 5-month study plan.
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 |
|---|---|---|
| Intravenous Laser Irradiation of BloodThe different color lights for Intravenous Laser Irradiation of Blood are red light at 808nm and blue light at 415nm | Device | Blue-Red Arm, Red-Blue Arm |
Primary outcome
Blood urea nitrogen (BUN) test
Time frame: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Can reveal whether your urea nitrogen levels are higher than normal, suggesting that your kidneys may not be working properly.
Creatinine test
Time frame: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Measure of how well your kidneys are performing their job of filtering waste from your blood.
Uric acid levels
Time frame: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Uric acid levels are typically 2.5-7.0 milligrams per deciliter (mg/dL) in males and 1.5-6.0 mg/dL in females. Low levels are rare, but high levels can lead to gout, kidney disease, and other health issues.
Blood cholesterol
Time frame: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood lipid control
Blood triglycerides
Time frame: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood lipid control
High-Density Lipoprotein levels
Time frame: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood lipid control
Low-Density Lipoprotein levels
Time frame: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood lipid control
Blood Glucose after meal
Time frame: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood glucose control
Hemoglobin A1c levels
Time frame: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood glucose control
Complete Blood Count test
Time frame: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood cell ratio control
Blood Prothrombin Time
Time frame: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood coagulation function control
Activated Partial Thromboplastin Time levels
Time frame: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood coagulation function control
Blood Tumor Necrosis Factor-alpha levels
Time frame: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood Inflammation control
Blood Interleukin-6 levels
Time frame: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood Inflammation control
High-sensitivity C-reactive Protein levels
Time frame: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood Inflammation control
Erythrocyte Sedimentation Rate levels
Time frame: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Indicates blood Inflammation control
Modified Rankin Scale (MRS)
Time frame: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
The Modified Rankin Scale is a scale that measures the degree of disability or dependence in daily activities following a neurological event, such as a stroke.
Barthel Index and IADL (Instrumental Activities of Daily Living) Scores
Time frame: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
Assesses a person's ability to perform basic activities of daily living (ADL), such as bathing, dressing, and feeding. Instrumental Activities of Daily Living extends the assessment to more complex activities, including managing finances and using transportation.
MMSE (Mini-Mental State Examination) Score
Time frame: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
MMSE is a widely used screening tool for cognitive impairment. It evaluates various cognitive functions, including orientation, memory, and language. Changes in MMSE scores may indicate alterations in cognitive abilities, providing insights into the impact of interventions on cognitive function.
Berg Balance Test Score
Time frame: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
The Berg Balance Test assesses a person's balance and risk of falling. It includes tasks such as standing on one foot and turning around. Changes in Berg Balance Test scores can indicate improvements or declines in balance and stability.
Fugl-Meyer Assessment Score
Time frame: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began
The Fugl-Meyer Assessment is commonly used to evaluate motor recovery after stroke. It assesses motor function, balance, and sensation. Changes in Fugl-Meyer scores can indicate improvements or declines in motor function and overall recovery.
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 9 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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 Intravenous Laser Irradiation of Blood in people with Stroke, run by Taipei Hospital, Ministry of Health and Welfare 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 4 inclusion and 4 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 9 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. 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?
Blood urea nitrogen (BUN) test (time frame: before treatment, two weeks after trial began, 2 months and two weeks after trial began, 3 months after trial began, 5 months after trial began). The study lists 21 primary outcomes in all. 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 9 Apr 2025.