Effect of Photobiomodulation Treatment in the Sublingual Region and Along the Spinal Column in Individuals With Multiple Sclerosis: Protocol for a Randomized, Controlled, Double-blind, Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Oxidative stress
研究概览
简要总结
Background: Multiple sclerosis (MS) is an autoimmune disease, for which the forms of treatment are medication and rehabilitation. However, in vitro and in vivo studies have demonstrated that photobiomodulation can be an effective treatment modality for inflammatory diseases, including MS. Photobiomodulation has a broad range of benefits, such as the avoidance of cell and tissue death, the stimulation of healing and injury repair, reductions in pain, edema and inflammation, cell proliferation and even apoptosis. The outcomes of photobiomodulation include the regeneration of cells, the stimulation of the growth of Schwann cells, a reduction in spasticity, functional improvements, a reduction in nitric oxide levels and the upregulation of the cytokine IL10, demonstrating that this therapeutic modality can offer neuro-protection.
Methods: A randomized, controlled, double-blind, clinical trial is proposed. The patients will be divided into six groups. Groups 1 and 2 will receive sham and active photobiomodulation in the sublingual region, respectively. Groups 3 and 4 will receive sham and active photobiomodulation along the spinal cord, respectively. Group 5 will receive placebo treatment with photobiomodulation on the skin in the region of the radial artery with a specific bracelet. Group 6 will be treated with photobiomodulation on the skin in the region of the radial artery with a specific bracelet.
Discussion: Treatment for MS is directed at the immune response and slowing the progression of the disease. This is one of the first clinical trials with sublingual and along the spinal cord photobiomodulation, which could help establish a new, promising treatment of the disease associated with pharmacological treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MS;
- •Age between 18 and 60 years;
- •Currently undergoing pharmacological treatment;
- •Capable of understanding and following verbal instructions;
- •score of < 7 on the Expanded Disability Status Scale;
- •No restriction will be imposed regarding gender.
排除标准
- •Other autoimmune diseases;
- •Neoplasias;
- •Heart failure;
- •Respiratory failure;
- •Renal insufficiency;
- •Hepatic insufficiency;
- •Acquired immunodeficiency syndrome;
- •Patients with relapses of the disease will be excluded from the study.
研究组 & 干预措施
Sham photobiomodulation in the sublingual region
A disposable plastic wrap will cover the application pen for the purposes of hygiene, and the laser will be placed for 10 minutes, without being turned on.
干预措施: Photobiomodulation in the sublingual region (Radiation)
Photobiomodulation in the sublingual region
A disposable plastic wrap will cover the application pen for the purposes of hygiene, and the region will be irradiated for 10 minutes.
干预措施: Photobiomodulation in the sublingual region (Radiation)
Sham photobiomodulation along the spinal cord
Transcutaneous irradiation of the spinal cord will be pretended on segments corresponding to the nerve roots of the lumbosacral plexus (T12-S5) and cervicothoracic plexus (C5-T1-2). Twenty points will be wakely irradiated for 30 seconds (total treatment time: 10 minutes).
干预措施: Photobiomodulation in the spinal cord (Radiation)
Photobiomodulation along the spinal cord
Transcutaneous irradiation of the spinal cord will be performed on segments corresponding to the nerve roots of the lumbosacral plexus (T12-S5) and cervicothoracic plexus (C5-T1-2). Twenty points will be irradiated for 30 seconds (total treatment time: 10 minutes).
干预措施: Photobiomodulation in the spinal cord (Radiation)
Sham Photobiomodulation in the radial artery
Intravascular laser irradiation will be applied to the skin in the region of the radial artery with a specific turned-off bracelet of the DMC laser Therapy EC model.
干预措施: Photobiomodulation in the radial artery (Radiation)
Photobiomodulation in the radial artery
Intravascular laser irradiation will be applied to the skin in the region of the radial artery with a specific bracelet of the DMC laser Therapy EC model.
干预措施: Photobiomodulation in the radial artery (Radiation)
结局指标
主要结局
Oxidative stress
时间窗: Through study completion, about one year.
The concentration of endogenous nitrite will be evaluated in serum samples using the Total Nitric Oxide and Nitrate/Nitrite Parameter Assay Kit (R\&D) according to the manufacturer´s instructions. Briefly, 50 µL sample will be incubated in 96 well plates with the reaction diluent provided by the kit, Griess Reagent I and II for 10 min at room temperature. Reactions will be read at 540 nm.
Tumor Necrosis Factor Alpha
时间窗: Through study completion, about one year.
The quantification of the serum levels of IL-10 and TNFα will be performed using the Human IL-10 and THF-alpha ELISA MAX (Biolegend), according to the manufacturer's instructions. Briefly, plates will be coated with the capture anti-IL-10 or anti-TNF-alpha monoclonal antibody for 18h at 8°C, washed and then incubated with the reagent provided by the kit to block non-specific binding and to reduce background. Samples will be added to each well at room temperature for 2h and after wash, detection antibody solution will be added. Reactions will be revealed with the Avidin-HRP solution and the absorbance will be read at 450nm.
Interleukin-10
时间窗: Through study completion, about one year.
The quantification of the serum levels of IL-10 and TNFα will be performed using the Human IL-10 and THF-alpha ELISA MAX (Biolegend), according to the manufacturer's instructions. Briefly, plates will be coated with the capture anti-IL-10 or anti-TNF-alpha monoclonal antibody for 18h at 8°C, washed and then incubated with the reagent provided by the kit to block non-specific binding and to reduce background. Samples will be added to each well at room temperature for 2h and after wash, detection antibody solution will be added. Reactions will be revealed with the Avidin-HRP solution and the absorbance will be read at 450nm.
次要结局
- EDSS(Through study completion, about one year.)
研究者
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho