NCT03360487

Effect of Photobiomodulation Treatment in Individuals With Multiple Sclerosis:

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: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: University of Nove de Julho · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
RADIATION	Photobiomodulation in the sublingual region	In the group submitted to sublingual irradiation, disposable plastic wrap will cover the application pen for the purposes of hygiene, and irradiation will take 10 minutes.
RADIATION	Photobiomodulation in 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).
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.

Timeline

• Start date: 2018-01-01
• Primary completion: 2018-12-31
• Completion: 2019-02-28
• First posted: 2017-12-04
• Last updated: 2018-10-11

Locations

1 site across 1 country: Brazil