Clinical trial NCT05456750: The Investigation of Therapeutic Effect and Platelet Activity After ILIB for Ischemic Stroke Patient
Official title: The Investigation of Therapeutic Effect and Platelet Activity After Intravenous Laser Irradiation of Blood for Ischemic Stroke Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Keywords: Ischemic Stroke
intravenous laser irradiation of blood
platele activity
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is to therapeutic effect and platelet activity after intravenous laser irradiation of blood for ischemic stroke patient

Detailed description: 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 in platelet activity 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 rehabilitation 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 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). 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 peripheral venous 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 and Stroke Impact Scale (SIS).

Eligibility criteria: 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

Primary outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 3 month
measure: Modified Rankin Scale (mRS)
timeFrame: 3 month
measure: Stroke Impact Scale(SIS)
timeFrame: 3 month
Secondary outcomes:
measure: Platelet activity
timeFrame: 3 month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-service general hospital
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
name: Liang-Cheng Chen, MD,MS
role: PRINCIPAL_INVESTIGATOR
References: