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

NCT06232499 | Completed

• 1 other identifier: 202406
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Stroke; Intravenous Laser Irradiation of Blood; Recurrent stroke risk factors

Outcome Measures

Primary Outcomes (21)

• Blood urea nitrogen (BUN) test

  Can reveal whether your urea nitrogen levels are higher than normal, suggesting that your kidneys may not be working properly.

  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

• Creatinine test

  Measure of how well your kidneys are performing their job of filtering waste from your blood.

  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

  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.

  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

• Blood cholesterol

  Indicates blood lipid control

  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

• Blood triglycerides

  Indicates blood lipid control

  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

• High-Density Lipoprotein levels

  Indicates blood lipid control

  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

• Low-Density Lipoprotein levels

  Indicates blood lipid control

  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

• Blood Glucose after meal

  Indicates blood glucose control

  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

• Hemoglobin A1c levels

  Indicates blood glucose control

  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

• Complete Blood Count test

  Indicates blood cell ratio control

  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

• Blood Prothrombin Time

  Indicates blood coagulation function control

  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

• Activated Partial Thromboplastin Time levels

  Indicates blood coagulation function control

  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

• Blood Tumor Necrosis Factor-alpha levels

  Indicates blood Inflammation control

  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

• Blood Interleukin-6 levels

  Indicates blood Inflammation control

  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

• High-sensitivity C-reactive Protein levels

  Indicates blood Inflammation control

  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

• Erythrocyte Sedimentation Rate levels

  Indicates blood Inflammation control

  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

• Modified Rankin Scale (MRS)

  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.

  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

• Barthel Index and IADL (Instrumental Activities of Daily Living) Scores

  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.

  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 (Mini-Mental State Examination) Score

  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.

  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

• Berg Balance Test Score

  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.

  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

• Fugl-Meyer Assessment Score

  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.

  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

Study Arms (2)

Red-Blue Arm

EXPERIMENTAL

Participants in this arm first receive 10 sessions of vascular laser treatment with red light, followed by a two-month washout period, and then receive 10 sessions of vascular laser treatment with blue light.

Device: Intravenous Laser Irradiation of Blood

Blue-Red Arm

EXPERIMENTAL

Participants in this arm first receive 10 sessions of vascular laser treatment with blue light, followed by a two-month washout period, and then receive 10 sessions of vascular laser treatment with red light.

Device: Intravenous Laser Irradiation of Blood

Interventions

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

Blue-Red Arm; Red-Blue Arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Hospital, Ministry of Health and Welfare: lead

Study Sites (1)

Taipei Hospital, Ministry of Health and Welfare

New Taipei City, ROC, 24213, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 30, 2024
• Study Start: January 10, 2024
• Primary Completion: December 14, 2024
• Study Completion: December 14, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)