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

Tri-Service General Hospital

Status: Completed

Conditions: Ischemic Stroke

Treatments: Procedure: ILIB; Procedure: Sham Control

Study type: Interventional

Funder types: Other

Identifiers

NCT06932627

TSGH-D-111109

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups

ILIB therapy

Experimental group

Description:

The treatment group 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 laser power is set between 5 Mw, 30 minutes each time, once everyother day for 3 consecutive days each week, for 2 weeks (total 6 times in one course)

Treatment:

Procedure: ILIB

sham control

Sham Comparator group

Description:

The steps for the control group are the same as the treatment group, except that the output power is adjusted to zero intensity.

Treatment:

Procedure: Sham Control