Therapeutic Effect of Intravascular Laser Irradiation of Blood

NCT03724799 | Unknown

• 1 other identifier: MOST 107-2314-B-016-074 -
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Low-Level Laser Therapy

Outcome Measures

Primary Outcomes (1)

• microcirculatory function of the skin

  Laser Doppler Flowmetry is reliable for assessing microcirculatory status.

  12 days

Study Arms (1)

single arm

EXPERIMENTAL

Intravenous low level laser therapy

Device: Intravascular laser irradiation of blood for the patients with cerebral infarction

Interventions

Intravascular laser irradiation of blood for the patients with cerebral infarction DEVICE

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.

single arm

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Officials

• Cheng-Chiang Chang, MD. PhD.

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng-Chiang Chang, MD. PhD.

CONTACT

886-2- 87923311; doc31146@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 28, 2018
• First Posted: October 30, 2018
• Study Start: November 14, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: November 16, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share