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

NCT06932627 | Completed

• 1 other identifier: TSGH-D-111109
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

Ischemic Stroke; intravenous laser irradiation of blood; mitochondria activity

Outcome Measures

Primary Outcomes (1)

• National Institutes of Health Stroke Scale (NIHSS)

  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.

  3 month

Secondary Outcomes (1)

• Modified Rankin Scale (mRS)

  3 month

Study Arms (2)

ILIB therapy

EXPERIMENTAL

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)

Procedure: ILIB

sham control

SHAM COMPARATOR

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

Procedure: Sham Control

Interventions

ILIB PROCEDURE

The treatment group receive an intravenous 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 every other day for 3 consecutive days each week, for 2 weeks (total 6 times in one course)

ILIB therapy

Sham Control PROCEDURE

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

sham control

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-service general hospital

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician and lecturer of Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 17, 2025
• Study Start: August 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 17, 2025

Record last verified: 2024-04

Locations

TW (1)