Trial Outcomes & Findings for the Investigation of Therapeutic Effect After ILIB for Ischemic Stroke Patient (NCT NCT05456750)
NCT ID: NCT05456750
Last Updated: 2026-06-17
Results Overview
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.
COMPLETED
NA
22 participants
3 months post therapy at 3.5 months
2026-06-17
Participant Flow
12
10
Participant milestones
| Measure |
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)
|
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.
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|---|---|---|
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Overall Study
STARTED
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12
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10
|
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Overall Study
COMPLETED
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12
|
10
|
|
Overall Study
NOT COMPLETED
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0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment Group
n=12 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)
|
Control Group
n=10 Participants
The steps for the control group are the same as the treatment group, except that the output power is adjusted to zero intensity.
|
Total
n=22 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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63.75 years
STANDARD_DEVIATION 8.8 • n=12 Participants
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61.8 years
STANDARD_DEVIATION 10.5 • n=10 Participants
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62.75 years
STANDARD_DEVIATION 8 • n=22 Participants
|
|
Sex: Female, Male
Female
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6 Participants
n=12 Participants
|
3 Participants
n=10 Participants
|
9 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=12 Participants
|
7 Participants
n=10 Participants
|
13 Participants
n=22 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
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0 Participants
Race and Ethnicity were not collected from any participant.
|
|
history of diabetes mellitus
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4 Participants
n=12 Participants
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6 Participants
n=10 Participants
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10 Participants
n=22 Participants
|
PRIMARY outcome
Timeframe: 3 months post therapy at 3.5 monthsThe 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.
Outcome measures
| Measure |
Treatment Group
n=12 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)
|
Control Group
n=10 Participants
The steps for the control group are the same as the treatment group, except that the output power is adjusted to zero intensity.
|
|---|---|---|
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Modified Rankin Scale (mRS)
|
2.33 scores on a scale
Standard Deviation 0.88
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2.3 scores on a scale
Standard Deviation 1.252
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SECONDARY outcome
Timeframe: 3 months post therapy at 3.5 monthsNIHSS 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.
Outcome measures
| Measure |
Treatment Group
n=12 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)
|
Control Group
n=10 Participants
The steps for the control group are the same as the treatment group, except that the output power is adjusted to zero intensity.
|
|---|---|---|
|
National Institutes of Health Stroke Scale (NIHSS)
|
3.83 scores on a scale
Standard Deviation 3.38 • Interval 0.45 to 7.21
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5.3 scores on a scale
Standard Deviation 4.278 • Interval 1.03 to 9.57
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SECONDARY outcome
Timeframe: 3 months post therapy at 3.5 monthsThe 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.
Outcome measures
| Measure |
Treatment Group
n=12 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)
|
Control Group
n=10 Participants
The steps for the control group are the same as the treatment group, except that the output power is adjusted to zero intensity.
|
|---|---|---|
|
Stroke Impact Scale(SIS)
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204.17 scores on a scale
Standard Deviation 34.43 • Interval 169.74 to 238.6
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210.3 scores on a scale
Standard Deviation 64.48 • Interval 145.82 to 274.78
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SECONDARY outcome
Timeframe: 3 months post therapy at 3.5 monthsThe 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).
Outcome measures
| Measure |
Treatment Group
n=12 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)
|
Control Group
n=10 Participants
The steps for the control group are the same as the treatment group, except that the output power is adjusted to zero intensity.
|
|---|---|---|
|
The Fugl-Meyer Assessment-Motor Function
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47.58 scores on a scale
Standard Deviation 20.03
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46.6 scores on a scale
Standard Deviation 24.39
|
SECONDARY outcome
Timeframe: 3 months post therapy at 3.5 monthsis a widely used functional evaluation tool that quantifies the distance an individual can walk over a flat surface within 6 minutes.
Outcome measures
| Measure |
Treatment Group
n=12 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)
|
Control Group
n=10 Participants
The steps for the control group are the same as the treatment group, except that the output power is adjusted to zero intensity.
|
|---|---|---|
|
The 6-minute Walk Test
|
219.67 meter
Standard Deviation 126.47
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224.3 meter
Standard Deviation 150.44
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Adverse Events
Treatment Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place