Therapeutic Effect of Intravascular Laser Irradiation of Blood

The Investigation of Therapeutic Effect and Molecular Mechanism After Intravascular Laser Irradiation of Blood

The investigators' previous studies results showed that the non-invasive treatment effects of low-energy lasers with the period of 5 consecutive days, could significantly improve the local function of static and dynamic motion stability of the lower extremities (p<0.0001) among the participants with lower limb periostitis. Therefore, investigators would like to further understand the treatment effect of intravascular low-energy laser on the central nervous system disorders. It is hoped that with this study, investigators can better understand how to use intravenous laser therapy to help those participants improve their ability of self-care and functional recovery.

Study Overview

• Status: Unknown
• Conditions: Low-Level Laser Therapy
• Intervention / Treatment: Device: Intravascular laser irradiation of blood for the patients with cerebral infarction

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cheng-Chiang Chang, MD. PhD.; Phone Number: 13782 886-2- 87923311; Email: doc31146@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Healthy controls

Inclusion Criteria:

• Written informed consent that is consistent with ICH-GCP guidelines(The International Conference on Harmonisation's Guideline for Good Clinical Practice).
• Age ≥ 18 years and ≤80 years of age.
• Body weight ≥40 kg

Exclusion Criteria:

• Subjects with cranial metallic implants, cardiac pacemakers or claustrophobia.
• Previous diagnosis of stroke or dementia
• Significant history of depression
• History of symptomatic stroke
• History of seizures
• History or presence of any other major neurological disease
• Myocardial infarction within prior 6 months.
• Known presence of any malignancy
• Patients with bleeding tendency or coagulation profile abnormalities
• Have a serious infection or other serious medical illness that requires treatment and/or hospitalization within 90 days before study entry.
• Have received any of the following within 6 months of study entry: systemic corticosteroids; chemotherapy or radiation; erythropoietin, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), or growth hormone; drugs that affect the immune system including thalidomide, interleukins, interferons, or other cytokines; anabolic steroids at high levels; or any experimental agent, unless allowed otherwise by the researchers.
• Participation in any other investigational trial within 4 weeks of initial screening and within 7 weeks of study entry
• Contraindications to head CT, MRI, or SPECT
• Pregnant or lactating
• Botox treatment to the involved arm within three months of enrollment
• Subjects with conscious disturbance or moderate to severe aphasia

Stroke group:

Inclusion Criteria:

• Written informed consent that is consistent with ICH-GCP guidelines.
• Age ≥ 18 years and ≤80 years of age. Substantial unilateral motor impairment
• At least 6 months post thromboembolic ischemic stroke in subcortical region of MCA or lenticulostriate artery with or without cortical involvement.
• Between 6 and 24 months post-stroke, and having a motor or sensory neurological deficit
• No significant further improvement with physical therapy/rehabilitation
• Able and willing to undergo computed tomography (CT), magnetic resonance imaging (MRI), and single photon emission tomography (SPECT) scans of the head

Exclusion Criteria:

• History of more than 1 symptomatic stroke
• History of seizures
• History or presence of any other major neurological disease
• Myocardial infarction within prior 6 months.
• Known presence of any malignancy
• Patients with bleeding tendency or coagulation profile abnormalities
• Have a serious infection or other serious medical illness that requires treatment and/or hospitalization within 90 days before study entry.
• Have received any of the following within 6 months of study entry: systemic corticosteroids; chemotherapy or radiation; erythropoietin, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), or growth hormone; drugs that affect the immune system including thalidomide, interleukins, interferons, or other cytokines; anabolic steroids at high levels; or any experimental agent, unless allowed otherwise by the researchers.
• Participation in any other investigational trial within 4 weeks of initial screening and within 7 weeks of study entry
• Contraindications to head CT, MRI, or SPECT
• Pregnant or lactating
• Botox treatment to the involved arm within three months of enrollment
• Subjects with conscious disturbance or moderate to severe aphasia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: single arm; Intravenous low level laser therapy	Device: Intravascular laser irradiation of blood for the patients with cerebral infarction; Intravenous low level therapy has been a variety of applications in many different areas of medicine with a growing interest. It possesses laser specific biomodulation, analgesic, spasmolytic and even sedative effects among many other.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
microcirculatory function of the skin	Laser Doppler Flowmetry is reliable for assessing microcirculatory status.	12 days

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital
• Investigators: Principal Investigator: Cheng-Chiang Chang, MD. PhD., Tri-Service General Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 14, 2018
• Primary Completion (ANTICIPATED): September 30, 2019
• Study Completion (ANTICIPATED): September 30, 2019

Study Registration Dates

• First Submitted: October 28, 2018
• First Submitted That Met QC Criteria: October 28, 2018
• First Posted (ACTUAL): October 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2018
• Last Update Submitted That Met QC Criteria: November 15, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: MOST 107-2314-B-016-074 -

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No