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NCT Number: NCT06232499

Effects of Intravenous Laser Irradiation of Blood Treatment With Different Colored Lights on Controlling Recurrent Stroke Risk Factors and Neurological Function in Stroke Patients

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.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Hospital, Ministry of Health and Welfare

New Taipei City, ROC, 24213, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Intravenous Laser Irradiation of Blood

Device

The different color lights for Intravenous Laser Irradiation of Blood are red light at 808nm and blue light at 415nm

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

Sponsors and collaborators

Lead sponsor

Taipei Hospital, Ministry of Health and Welfare

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 30, 2024
Registry last updated
Apr 9, 2025

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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