the Investigation of Therapeutic Effect After ILIB for Ischemic Stroke Patient

NCT05456750 | Completed Results

• 1 other identifier: TSGH-D-111106
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to therapeutic effect after intravenous laser irradiation of blood for ischemic stroke patient

Conditions

Ischemic Stroke

Keywords

Ischemic Stroke; intravenous laser irradiation of blood

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale (mRS)

  The Modified Rankin Scale (mRS) is used to measure the degree of disability or dependence in the daily activities in patients who have had a stroke 0: No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.

  3 months post therapy at 3.5 months

Secondary Outcomes (4)

• National Institutes of Health Stroke Scale (NIHSS)

  3 months post therapy at 3.5 months

• Stroke Impact Scale(SIS)

  3 months post therapy at 3.5 months

• The Fugl-Meyer Assessment-Motor Function

  3 months post therapy at 3.5 months

• The 6-minute Walk Test

  3 months post therapy at 3.5 months

Study Arms (2)

treatment group

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 2.5 \~ 3.0Mw, 60 minutes each time, once a day for five consecutive days each week, for 2 weeks (total 10 times in one course)

Device: Intravascular laser irradiation of blood

control group

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.

Device: Intravascular laser irradiation of blood

Interventions

Intravascular laser irradiation of blood DEVICE

Low intensity intravenous laser irradiation of blood phototherapy is a method of a 632.8 nm red light penetrate into a vein through fiber and the brightness is 100 fold of the sun. The light accelerates blood and cells circulation in the human body, so that protein molecular structure would promote changes.

control group; treatment group

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, 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

Limitations and Caveats

1. the sample size was small; the results should be interpreted as preliminary efficacy signals rather than definitive conclusions. 2. outcomes were only monitored for 3 months; long-term follow-up is needed to assess the sustained effects of ILIB therapy beyond this timeframe. 3. one course of ILIB therapy was administered, highlighting the need for further research on the cumulative therapeutic benefits of multiple courses.

Results Point of Contact

• Title: Su Yu-Chi
• Organization: Tri-service general hospital

vickysu0110@gmail.com

+8860287923311

Study Officials

• Liang-Cheng Chen, MD,MS

  Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2022
• First Posted: July 13, 2022
• Study Start: July 28, 2022
• Primary Completion: July 31, 2024
• Study Completion: August 31, 2024
• Last Updated: June 17, 2026
• Results First Posted: June 17, 2026

Record last verified: 2026-02

Locations

TW (1)