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

NCT ID: NCT06232499

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-10

Study Completion Date

2024-12-14

Brief Summary

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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

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Red-Blue Arm

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.

Group Type EXPERIMENTAL

Intravenous Laser Irradiation of Blood

Intervention Type DEVICE

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

Blue-Red Arm

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.

Group Type EXPERIMENTAL

Intravenous Laser Irradiation of Blood

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Hospital, Ministry of Health and Welfare

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taipei Hospital, Ministry of Health and Welfare

New Taipei City, ROC, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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202406

Identifier Type: -

Identifier Source: org_study_id

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