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NCT06932627Completed

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

Effects of Intravascular Laser Irradiation of Blood for Mitochondral Dysfunction and Oxidative Stress in Adults With Chronic Cerebral Ischemic Stroke

Source: ClinicalTrials.gov · Last updated 17 Apr 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
8 (actual)
First submitted
10 Apr 2025
Start date
1 Aug 2023
Primary completion date
31 Dec 2024
Lead sponsor
Tri-Service General Hospital (TSGH)
Diseases
Stroke
NCT number
NCT06932627

What you commit to

  • Study type: Interventional
  • Participants enrolled: 8
  • From 1 Aug 2023 to the primary completion date, 31 Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Other

  • Pregnancy

Who the study is looking for

  • 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

Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Tri-Service General Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.