Therapeutic Effect of Intravascular Laser Irradiation of Blood
Raktažodžiai
Santrauka
Datos
| Paskutinį kartą patikrinta: | 10/31/2018 |
| Pirmasis pateikimas: | 10/27/2018 |
| Numatytas registravimas pateiktas: | 10/27/2018 |
| Pirmas paskelbtas: | 10/29/2018 |
| Paskutinis atnaujinimas pateiktas: | 11/14/2018 |
| Paskutinis atnaujinimas paskelbtas: | 11/15/2018 |
| Faktinė studijų pradžios data: | 11/13/2018 |
| Numatoma pirminio užbaigimo data: | 09/29/2019 |
| Numatoma studijų užbaigimo data: | 09/29/2019 |
Būklė ar liga
Intervencija / gydymas
Device: single arm
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: single arm Intravenous low level laser therapy | Device: single arm 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. |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 20 Years Į 20 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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 |
Rezultatas
Pirminės rezultatų priemonės
1. microcirculatory function of the skin [12 days]
