Therapeutic Effect of Intravascular Laser Irradiation of Blood

Tri-Service General Hospital

Status

Unknown

Conditions

Low-Level Laser Therapy

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03724799

MOST 107-2314-B-016-074 -

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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