Clinical trial NCT03360487: Effect of Photobiomodulation Treatment in Individuals With Multiple Sclerosis:
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Multiple Sclerosis
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Oxidative stress
timeFrame: Through study completion, about one year.
measure: Tumor Necrosis Factor Alpha
timeFrame: Through study completion, about one year.
measure: Interleukin-10
timeFrame: Through study completion, about one year.
Secondary outcomes:
measure: EDSS
timeFrame: Through study completion, about one year.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: UNINOVE
state: SP
Study officials:
References:
citation: Silva T, Alencar RC, de Souza Silva BC, Viana ECOM, Fragoso YD, Gomes AO, Cristina Chavantes M, Deana AM, Gallo JMAS, Fernandes KPS, Mesquita-Ferrari RA, Bussadori SK. Effect of photobiomodulation on fatigue in individuals with relapsing-remitting multiple sclerosis: a pilot study. Lasers Med Sci. 2022 Oct;37(8):3107-3113. doi: 10.1007/s10103-022-03567-3. Epub 2022 May 2.
citation: Silva T, Fragoso YD, Destro Rodrigues MFS, Gomes AO, da Silva FC, Andreo L, Viana A, Teixeira da Silva DF, Chavantes MC, Tempestini Horliana ACR, De Angelis K, Deana AM, Branco LP, Santos Fernandes KP, Motta LJ, Mesquita-Ferrari RA, Bussadori SK. Effects of photobiomodulation on interleukin-10 and nitrites in individuals with relapsing-remitting multiple sclerosis - Randomized clinical trial. PLoS One. 2020 Apr 7;15(4):e0230551. doi: 10.1371/journal.pone.0230551. eCollection 2020.