Multiple Sclerosis Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 34 |
Est. completion date | February 28, 2019 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | UNINOVE | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
University of Nove de Julho |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oxidative stress | 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. | Through study completion, about one year. | |
Primary | Tumor Necrosis Factor Alpha | The quantification of the serum levels of IL-10 and TNFa 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. | Through study completion, about one year. | |
Primary | Interleukin-10 | The quantification of the serum levels of IL-10 and TNFa 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. | Through study completion, about one year. | |
Secondary | EDSS | The participants will be evaluated before and after treatment using the Expanded Disability Status Scale administered by a physiotherapist. | Through study completion, about one year. |
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