Effects of Intravenous Laser Irradiation of Blood Treatment With Different Colored Lights on Controlling Recurrent Stroke Risk Factors and Neurological Function in Stroke Patients
- Conditions
- Stroke
- Interventions
- Device: Intravenous Laser Irradiation of Blood
- Registration Number
- NCT06232499
- Lead Sponsor
- Taipei Hospital, Ministry of Health and Welfare
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Red-Blue Arm Intravenous Laser Irradiation of Blood 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. Blue-Red Arm Intravenous Laser Irradiation of Blood 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.
- Primary Outcome Measures
Name Time Method Uric acid levels 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.
Barthel Index and IADL (Instrumental Activities of Daily Living) Scores 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.
Creatinine test 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.
Blood triglycerides 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
Low-Density Lipoprotein levels 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
Hemoglobin A1c levels 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
Blood Prothrombin Time 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
Activated Partial Thromboplastin Time levels 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
Modified Rankin Scale (MRS) 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.
Blood urea nitrogen (BUN) test 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.
Blood cholesterol 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
Blood Glucose after meal 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
Blood Interleukin-6 levels 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
High-sensitivity C-reactive Protein levels 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
MMSE (Mini-Mental State Examination) Score 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.
Berg Balance Test Score 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.
High-Density Lipoprotein levels 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
Complete Blood Count test 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
Blood Tumor Necrosis Factor-alpha levels 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
Erythrocyte Sedimentation Rate levels 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
Fugl-Meyer Assessment Score 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Taipei Hospital, Ministry of Health and Welfare
🇨🇳New Taipei City, ROC, Taiwan