Effects of Intravascular Laser Irradiation of Blood for Mitochondral Dysfunction in Cerebral Ischemic Stroke

Not Applicable

Completed

• Conditions: Ischemic Stroke

• Registration Number: NCT06932627
• Lead Sponsor: Tri-Service General Hospital

Brief Summary

Background : This research is designed through randomization, control, and double-blind trial to explore the clinical effectiveness of intravenous laser irradiation of blood for ischemic stroke patient; The research will further explore the changes of mitochondria function after treatment. The light accelerates blood and cells circulation in the human body, so that protein molecular structure would promote changes. Pain control is indicated in such treatment, but still lacking evidence of neurological symptoms and functional improvement.

Purpose:This research is designed through randomization, control, and double-blind trial to therapeutic effect and platelet activity after intravenous laser irradiation of blood for ischemic stroke patient. Furthermore, to establish a new way of clinical therapy.

Method: The investigators plan to recruit 20 patients who are between the ages of 20 to 80 years old. The participants are required to have clear conscious and be able to communicate. The patient with mild to moderate stroke ( NIHSS=1-15), which onset between one month to 2 years will be included. The treatment group will receive an intravenous helium-neon laser phototherapy. A vein indwelling needle will be placed in their veins located in the upper elbow, and the laser fiber catheter will be introduced through the indwelling cannula. The power is set between 5Mw, 30 minutes each time, once everyother day for 3 days each week, for 2 weeks (total 6 times in one course). The steps for the control group are the same, except that the output power is adjusted to zero intensity. This plan will be explained to the patient in detail during the outpatient visit and patients will sign the consent form upon agreement. Before intravenous laser irradiation,three days, one month, and three months after the therapy, 20 ml of autologous peripheralvenous blood need to be drawn for basic blood tests and platelet activity tests. At the same time, the clinical functions of patients will be evaluated, including NIHSS, mRS.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-01
• Status Verified: 2024-04
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Study First Submitted: 2025-04-10
• Study First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Study First Posted: 2025-04-17
• Last Update Posted: 2025-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Aged between 20 to 80 years old
• Able to speak and understand Mandarin/Taiwanese
• No cognitive impairment
• Residual motor function impairment (mRS>1)
• Mild stroke (NIHSS=1-4) or Moderate stroke(NIHSS=5-15)
• No psychological disease

Exclusion Criteria

• Severe stroke (NIHSS=16-42)
• History of intracerebral hemorrhage and other major surgery
• History of malignancy, chronic kidney disease
• Active infection
• Chronic hepatitis B or Chronic hepatitis C
• Unstable angina or acute myocardial infarction within 6 months
• Severe cognition impairment
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
National Institutes of Health Stroke Scale (NIHSS)	3 month	NIHSS is a measure of the severity of symptoms associated with ischemic strokeand is used as a quantitative measure of neurological deficit post stroke. NIHSSscore is composed of 11 items, including consciousness, eye movement, visualfields, muscle power of four limbs, limbs ataxia, sensation, language, dysarthria andextinction. Each of which scores a specific ability between a 0 and 4. For each item,a score of 0 typically indicates normal function in that specific ability, while a higherscore is indicative of some level of impairment. Total score are between 0-42.; Measure before intravenous laser irradiation, three days, one month, and threemonths after the therapy.

Secondary Outcome Measures

Name	Time	Method
Modified Rankin Scale (mRS)	3 month	The Modified Rankin Scale (mRS) is used to measure the degree of disability ordependence in the daily activities in patients who have had a stroke 0: Nosymptoms at all

Trial Locations

Locations (1)

Tri-service general hospital; 🇨🇳 Taipei, Taiwan