Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06232499
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-01-04
Brief 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
Sponsor:
Taipei Hospital Ministry of Health and Welfare
Organization:
Taipei Hospital Ministry of Health and Welfare
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 6328nm 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
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 6328nm 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None