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Effect of Photobiomodulation Treatment in Individuals With Multiple Sclerosis:

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ClinicalTrials.gov Identifier: NCT03360487
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Sandra Kalil Bussadori, University of Nove de Julho

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Radiation: Photobiomodulation in the sublingual region Radiation: Photobiomodulation in the spinal cord Radiation: Photobiomodulation in the radial artery Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Sham photobiomodulation in the sublingual region
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.
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.

Active Comparator: Photobiomodulation in the sublingual region
A disposable plastic wrap will cover the application pen for the purposes of hygiene, and the region will be irradiated for 10 minutes.
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.

Sham Comparator: Sham photobiomodulation along the spinal cord
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).
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).

Active Comparator: Photobiomodulation along 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 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).

Sham Comparator: Sham Photobiomodulation in the radial artery
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.
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.

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. Oxidative stress [ Time Frame: Through study completion, about one year. ]
    The concentration of endogenous nitrite will be evaluated in serum samples using the Total Nitric Oxide and Nitrate/Nitrite Parameter Assay Kit (R&D) according to the manufacturer´s instructions. Briefly, 50 µL sample will be incubated in 96 well plates with the reaction diluent provided by the kit, Griess Reagent I and II for 10 min at room temperature. Reactions will be read at 540 nm.

  2. Tumor Necrosis Factor Alpha [ Time Frame: Through study completion, about one year. ]
    The quantification of the serum levels of IL-10 and TNFα will be performed using the Human IL-10 and THF-alpha ELISA MAX (Biolegend), according to the manufacturer's instructions. Briefly, plates will be coated with the capture anti-IL-10 or anti-TNF-alpha monoclonal antibody for 18h at 8°C, washed and then incubated with the reagent provided by the kit to block non-specific binding and to reduce background. Samples will be added to each well at room temperature for 2h and after wash, detection antibody solution will be added. Reactions will be revealed with the Avidin-HRP solution and the absorbance will be read at 450nm.

  3. Interleukin-10 [ Time Frame: Through study completion, about one year. ]
    The quantification of the serum levels of IL-10 and TNFα will be performed using the Human IL-10 and THF-alpha ELISA MAX (Biolegend), according to the manufacturer's instructions. Briefly, plates will be coated with the capture anti-IL-10 or anti-TNF-alpha monoclonal antibody for 18h at 8°C, washed and then incubated with the reagent provided by the kit to block non-specific binding and to reduce background. Samples will be added to each well at room temperature for 2h and after wash, detection antibody solution will be added. Reactions will be revealed with the Avidin-HRP solution and the absorbance will be read at 450nm.


Secondary Outcome Measures :
  1. EDSS [ Time Frame: Through study completion, about one year. ]
    The participants will be evaluated before and after treatment using the Expanded Disability Status Scale administered by a physiotherapist.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360487


Contacts
Contact: Tamiris da Silva, MS 1125571502 tamiris.slv@hotmail.com

Locations
Brazil
UNINOVE Recruiting
São Paulo, SP, Brazil, 01504-001
Contact: Tamiris da Silva    1125571502    tamiris.slv@hotmail.com   
Sponsors and Collaborators
University of Nove de Julho

Responsible Party: Sandra Kalil Bussadori, Principal Investigator, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT03360487     History of Changes
Other Study ID Numbers: FBMEM
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases