Effect of Photobiomodulation Treatment in Individuals With Multiple Sclerosis:

NCT ID: NCT03360487

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-02-28

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Photobiomodulation in the sublingual region

Intervention Type: RADIATION

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.

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.

Group Type: ACTIVE_COMPARATOR

Photobiomodulation in the sublingual region

Intervention Type: RADIATION

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 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).

Group Type: SHAM_COMPARATOR

Photobiomodulation in the spinal cord

Intervention Type: RADIATION

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).

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).

Group Type: ACTIVE_COMPARATOR

Photobiomodulation in the spinal cord

Intervention Type: RADIATION

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 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.

Group Type: SHAM_COMPARATOR

Photobiomodulation in the radial artery

Intervention Type: RADIATION

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.

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.

Group Type: ACTIVE_COMPARATOR

Photobiomodulation in the radial artery

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: 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).

Intervention Type: 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.

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Sandra Kalil Bussadori

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UNINOVE

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Tamiris da Silva, MS

Role: CONTACT

tamiris.slv@hotmail.com

1125571502

Facility Contacts

Tamiris da Silva

Role: primary

tamiris.slv@hotmail.com

1125571502

References

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.

Reference Type: DERIVED

PMID: 35499744 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32255785 (View on PubMed)

Other Identifiers

FBMEM

Identifier Type: -

Identifier Source: org_study_id