NCT03724799UnknownNot Applicable
The Investigation of Therapeutic Effect and Molecular Mechanism After Intravascular Laser Irradiation of Blood
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Tri-Service General Hospital
- Enrollment
- 12
- Primary Endpoint
- microcirculatory function of the skin
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
single arm
Experimental
Intravenous low level laser therapy
Intervention: Intravascular laser irradiation of blood for the patients with cerebral infarction (Device)
Outcomes
Primary Outcomes
microcirculatory function of the skin
Time Frame: 12 days
Laser Doppler Flowmetry is reliable for assessing microcirculatory status.
Secondary Outcomes
No secondary outcomes reported
Investigators
Cheng-Chiang Chang
Principal Investigator
Tri-Service General Hospital
Similar Trials
Completed
Not Applicable
PEMF Therapy to Treat Interstitial Cystitis/Bladder Pain SyndromeInterstitial CystitisChronic Interstitial CystitisBladder Pain SyndromeNCT04540887Wake Forest University Health Sciences10
Completed
Not Applicable
A clinical study to evaluate the effects of the indoor plants on recovery from fatigueHealthy volunteersJPRN-UMIN000035339Soiken Inc.36
Withdrawn
Phase 2
Peripheral Artery Occlusive Diseases (PAOD) Study - Clinical AssessmentPeripheral Artery DiseaseNCT00771797RWTH Aachen University
Not yet recruiting
Phase 3
A clinical trial to study the effect of collagen supplement on chronic periodontitis patient and on nitrtic oxide level in the saliva.CTRI/2024/05/068104Yogita Kshirsagar
Completed
Phase 4
Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard DoseMagnetic Resonance ImagingNCT03602339Bayer157