Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Intravenous Laser Irradiation of Blood
Recurrent stroke risk factors
Lead sponsor: Taipei Hospital, Ministry of Health and Welfare
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Blood urea nitrogen (BUN) test
timeFrame: 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: Creatinine test
timeFrame: 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: Uric acid levels
timeFrame: 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: Blood cholesterol
timeFrame: 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: Blood triglycerides
timeFrame: 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: High-Density Lipoprotein levels
timeFrame: 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: Low-Density Lipoprotein levels
timeFrame: 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: Blood Glucose after meal
timeFrame: 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: Hemoglobin A1c levels
timeFrame: 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: Complete Blood Count test
timeFrame: 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: Blood Prothrombin Time
timeFrame: 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: Activated Partial Thromboplastin Time levels
timeFrame: 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: Blood Tumor Necrosis Factor-alpha levels
timeFrame: 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: Blood Interleukin-6 levels
timeFrame: 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: High-sensitivity C-reactive Protein levels
timeFrame: 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: Erythrocyte Sedimentation Rate levels
timeFrame: 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: Modified Rankin Scale (MRS)
timeFrame: 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: Barthel Index and IADL (Instrumental Activities of Daily Living) Scores
timeFrame: 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: MMSE (Mini-Mental State Examination) Score
timeFrame: 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: Berg Balance Test Score
timeFrame: 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: Fugl-Meyer Assessment Score
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Hospital, Ministry of Health and Welfare
state: ROC
Study officials:
References: