Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of our study is to therapeutic effect after intravenous laser irradiation of blood for ischemic stroke patient
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravascular laser irradiation of blood | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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
| 3 months post therapy at 3.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Liang-Cheng Chen, MD,MS | Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri-service general hospital | Taipei | Taiwan |
10
12
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | 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) |
| FG001 | Control Group | The steps for the control group are the same as the treatment group, except that the output power is adjusted to zero intensity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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
| Posted | Mean | Standard Deviation | scores on a scale | 3 months post therapy at 3.5 months |
|
from enrollment until after the therapy for 3 months.
ILIB therapy is a safe modality treatment without the risk of mortality and severe side effects
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | 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) |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Su Yu-Chi | Tri-service general hospital | +8860287923311 | vickysu0110@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 18, 2026 | May 20, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. | 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). | 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. | 3 months post therapy at 3.5 months |
| BG001 | Control Group | The steps for the control group are the same as the treatment group, except that the output power is adjusted to zero intensity. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| history of diabetes mellitus | diabetes mellitus is a risk factor of ischemic stroke | Count of Participants | Participants |
|
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)
| OG001 | Control Group | The steps for the control group are the same as the treatment group, except that the output power is adjusted to zero intensity. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | scores on a scale | 3 months post therapy at 3.5 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | scores on a scale | 3 months post therapy at 3.5 months |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | scores on a scale | 3 months post therapy at 3.5 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | meter | 3 months post therapy at 3.5 months |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Control Group | In the control group, 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 output power is adjusted to zero intensity, 60 minutes each time, once a day for five consecutive days each week, for 2 weeks (total 10 times in one course) | 0 | 10 | 0 | 10 | 0 | 10 |
Not provided
Not provided
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |