Effect of Photobiomodulation Treatment in Individuals With Multiple Sclerosis:

University of Nove de Julho

Status and phase: Unknown; Phase 2

Conditions: Multiple Sclerosis

Treatments: Radiation: Photobiomodulation in the spinal cord; Radiation: Photobiomodulation in the sublingual region; Radiation: Photobiomodulation in the radial artery

Study type: Interventional

Funder types: Other

Identifiers

NCT03360487

FBMEM

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 6 patient groups

Sham photobiomodulation in the sublingual region

Sham Comparator group

Description:

A disposable plastic wrap will cover the application pen for the purposes of hygiene, and the laser will be placed for 10 minutes, without being turned on.

Treatment:

Radiation: Photobiomodulation in the sublingual region

Photobiomodulation in the sublingual region

Active Comparator group

Description:

A disposable plastic wrap will cover the application pen for the purposes of hygiene, and the region will be irradiated for 10 minutes.

Treatment:

Radiation: Photobiomodulation in the sublingual region

Sham photobiomodulation along the spinal cord

Sham Comparator group

Description:

Transcutaneous irradiation of the spinal cord will be pretended on segments corresponding to the nerve roots of the lumbosacral plexus (T12-S5) and cervicothoracic plexus (C5-T1-2). Twenty points will be wakely irradiated for 30 seconds (total treatment time: 10 minutes).

Treatment:

Radiation: Photobiomodulation in the spinal cord

Photobiomodulation along the spinal cord

Active Comparator group

Description:

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).

Treatment:

Radiation: Photobiomodulation in the spinal cord

Sham Photobiomodulation in the radial artery

Sham Comparator group

Description:

Intravascular laser irradiation will be applied to the skin in the region of the radial artery with a specific turned-off bracelet of the DMC laser Therapy EC model.

Treatment:

Radiation: Photobiomodulation in the radial artery

Photobiomodulation in the radial artery

Active Comparator group

Description:

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.

Treatment:

Radiation: Photobiomodulation in the radial artery