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

Taipei Hospital, Ministry of Health and Welfare

Status: Enrolling

Conditions: Stroke

Treatments: Device: Intravenous Laser Irradiation of Blood

Study type: Interventional

Funder types: Other

Identifiers

NCT06232499

202406

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Red-Blue Arm

Experimental group

Description:

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.

Treatment:

Device: Intravenous Laser Irradiation of Blood

Blue-Red Arm

Experimental group

Description:

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.

Treatment:

Device: Intravenous Laser Irradiation of Blood