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Completed

NCT Number: NCT05456750

the Investigation of Therapeutic Effect After ILIB for Ischemic Stroke Patient

The aim of our study is to therapeutic effect after intravenous laser irradiation of blood for ischemic stroke patient

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri-service general hospital

Taipei, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Modified Rankin Scale (mRS)

    Time frame: 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

    • No significant disability despite symptoms; able to carry out all usual duties and activities
    • Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
    • Moderate disability; requiring some help, but able to walk without assistance
    • Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    • Severe disability; bedridden, incontinent and requiring constant nursing care and attention
    • Dead Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.

Secondary outcomes

  1. National Institutes of Health Stroke Scale (NIHSS)

    Time frame: 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.

  2. Stroke Impact Scale(SIS)

    Time frame: 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.

  3. The Fugl-Meyer Assessment-Motor Function

    Time frame: 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).

  4. The 6-minute Walk Test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

The Investigation of Therapeutic Effect After Intravenous Laser Irradiation of Blood for Ischemic Stroke Patient

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 13, 2022
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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