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

Status unknownPhase 2MS (type not specified)NCT03360487

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Photobiomodulation in the sublingual region
  • Photobiomodulation in the spinal cord
  • Photobiomodulation in the radial artery

What it measured

Main measures

  • Oxidative stress

    Through study completion, about one year.

  • Tumor Necrosis Factor Alpha

    Through study completion, about one year.

    Immune response
  • Interleukin-10

    Through study completion, about one year.

    Immune response

Other measures (1)

  • EDSS

    Through study completion, about one year.

    Disability progression

Who could take part

MS (type not specified) · 18 to 60

Show the full criteria

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Jan 2018

    2. Main results due

      Dec 2018

    3. Finished

      Feb 2019

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