Effect of Photobiomodulation Treatment in Individuals With Multiple Sclerosis:

Last updated: October 10, 2018
Sponsor: University of Nove de Julho
Overall Status: Active - Recruiting

Phase

2

Condition

Multiple Sclerosis

Neurologic Disorders

Memory Loss

Treatment

N/A

Clinical Study ID

NCT03360487
FBMEM
  • Ages 18-60
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 34
Study Start date:
January 01, 2018
Estimated Completion Date:
February 28, 2019

Connect with a study center

  • UNINOVE

    São Paulo, SP 01504-001
    Brazil

    Active - Recruiting

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