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

Stroke Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06232499
• Other study ID #: 202406
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2024
• Est. completion date: December 14, 2024

Study information

• Verified date: March 2024
• Source: Taipei Hospital, Ministry of Health and Welfare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 14, 2024
• Est. primary completion date: December 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosed as a first-time stroke patient.

2. Onset of illness within 6 months of enrollment.

3. Recruitment period from January to December of the year 113.

4. All participants or their legal representatives must sign the informed consent form.

Exclusion Criteria:

1. Skin diseases that make injection or photosensitivity unsuitable.

2. Pregnancy and abnormal blood clotting function.

3. Presence of a cardiac pacemaker.

4. Inability to comply with the 5-month study plan.

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Taiwan	Taipei Hospital, Ministry of Health and Welfare	New Taipei City	ROC

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Hospital, Ministry of Health and Welfare

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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