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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

3 months post therapy at 3.5 months

Results posted on

2026-06-17

Participant Flow

12

10

Participant milestones

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.
Overall Study
STARTED
12
10
Overall Study
COMPLETED
12
10
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

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
Age, Continuous
63.75 years
STANDARD_DEVIATION 8.8 • n=12 Participants
61.8 years
STANDARD_DEVIATION 10.5 • n=10 Participants
62.75 years
STANDARD_DEVIATION 8 • n=22 Participants
Sex: Female, Male
Female
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
0 Participants
Race and Ethnicity were not collected from any participant.
history of diabetes mellitus
4 Participants
n=12 Participants
6 Participants
n=10 Participants
10 Participants
n=22 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

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.
Modified Rankin Scale (mRS)
2.33 scores on a scale
Standard Deviation 0.88
2.3 scores on a scale
Standard Deviation 1.252

SECONDARY outcome

Timeframe: 3 months post therapy at 3.5 months

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.

Outcome measures

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
5.3 scores on a scale
Standard Deviation 4.278 • Interval 1.03 to 9.57

SECONDARY outcome

Timeframe: 3 months post therapy at 3.5 months

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.

Outcome measures

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)
204.17 scores on a scale
Standard Deviation 34.43 • Interval 169.74 to 238.6
210.3 scores on a scale
Standard Deviation 64.48 • Interval 145.82 to 274.78

SECONDARY outcome

Timeframe: 3 months post therapy at 3.5 months

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).

Outcome measures

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
47.58 scores on a scale
Standard Deviation 20.03
46.6 scores on a scale
Standard Deviation 24.39

SECONDARY outcome

Timeframe: 3 months post therapy at 3.5 months

is a widely used functional evaluation tool that quantifies the distance an individual can walk over a flat surface within 6 minutes.

Outcome measures

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
224.3 meter
Standard Deviation 150.44

Adverse Events

Treatment Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Su Yu-Chi

Tri-service general hospital

Phone: +8860287923311

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place