Ischemic Stroke
Conditions
Keywords
Ischemic Stroke, intravenous laser irradiation of blood
Brief summary
The aim of our study is to therapeutic effect 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 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 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).
Interventions
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.
Sponsors
Tri-Service General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale (mRS) | 3 months post therapy at 3.5 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| National Institutes of Health Stroke Scale (NIHSS) | 3 months post therapy at 3.5 months | NIHSS is a measure of the severity of symptoms associated with ischemic stroke and is used as a quantitative measure of neurological deficit post stroke. NIHSS score is composed of 11 items, including consciousness, eye movement, visual fields, muscle power of four limbs, limbs ataxia, sensation, language, dysarthria and extinction. 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 higher score is indicative of some level of impairment. Total score are between 0-42. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy. |
| Stroke Impact Scale(SIS) | 3 months post therapy at 3.5 months | The Stroke Impact Scale (SIS) is a newly developed comprehensive outcome measure consists of items measuring 8 domains- strength (0-20), hand function (0-25), activities of daily living (ADL) and instrumental ADL (0-50), mobility (0-45), communication (0-35), emotion (0-45), memory and thinking (0-35), and participation (0-40). It was based on feedback from patients and their caregivers. The total score is 0-295. The higher scores indicating better function or less impact from stroke. |
| The Fugl-Meyer Assessment-Motor Function | 3 months post therapy at 3.5 months | The Fugl-Meyer Assessment - Motor Function (FMA-MF) subscale evaluates movement, reflexes, and coordination of the upper and lower extremities post-stroke. It is widely used as a standardized measure of motor recovery.Upper extremity subscale: 33 items, maximum score = 66.Lower extremity subscale: 17 items, maximum score = 34. Total motor domain score: Sum of upper and lower extremity subscales, maximum score = 100. Higher scores indicate better motor function and less impairment. Reported values in this study represent the total motor domain score (0-100). |
| The 6-minute Walk Test | 3 months post therapy at 3.5 months | is a widely used functional evaluation tool that quantifies the distance an individual can walk over a flat surface within 6 minutes. |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORLiang-Cheng Chen, MD,MS
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Participant flow
Recruitment details
12
Pre-assignment details
10
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 62.75 years STANDARD_DEVIATION 8 |
| history of diabetes mellitus | 6 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 10 |
| other Total, other adverse events | 0 / 12 | 0 / 10 |
| serious Total, serious adverse events | 0 / 12 | 0 / 10 |
Outcome results
None listed