Multiple SclerosisPhase 2NCT03360487
Effect of Photobiomodulation Treatment in Individuals With Multiple Sclerosis:
A Phase 2 study testing Photobiomodulation in the sublingual region, Photobiomodulation in the spinal cord and Photobiomodulation in the radial artery in people with Multiple Sclerosis, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Photobiomodulation in the sublingual region, Photobiomodulation in the spinal cord and Photobiomodulation in the radial artery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2018to 28 Feb 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
UNINOVE
São Paulo, São Paulo, 01504-001
Tamiris da Silva, 1125571502, tamiris.slv@hotmail.com
About this study
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
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
- Being tested
- Photobiomodulation in the sublingual region, Photobiomodulation in the spinal cord, Photobiomodulation in the radial artery
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation in the sublingual regionRadiation
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 spinal cordRadiation
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 in the radial arteryRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham photobiomodulation in the sublingual region | Sham comparator | 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. Receives: Radiation: Photobiomodulation in the sublingual region |
| Photobiomodulation in the sublingual region | Active comparator | A disposable plastic wrap will cover the application pen for the purposes of hygiene, and the region will be irradiated for 10 minutes. Receives: Radiation: Photobiomodulation in the sublingual region |
| Sham photobiomodulation along the spinal cord | Sham comparator | 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). Receives: Radiation: Photobiomodulation in the spinal cord |
| Photobiomodulation along the spinal cord | Active comparator | 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). Receives: Radiation: Photobiomodulation in the spinal cord |
| Sham Photobiomodulation in the radial artery | Sham comparator | 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. Receives: Radiation: Photobiomodulation in the radial artery |
| Photobiomodulation in the radial artery | Active comparator | 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. Receives: Radiation: Photobiomodulation in the radial artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress
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.
Measured: Through study completion, about one year.
Tumor Necrosis Factor Alpha
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.
Measured: Through study completion, about one year.
Interleukin-10
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.
Measured: Through study completion, about one year.
Secondary outcomes (1)
EDSS
The participants will be evaluated before and after treatment using the Expanded Disability Status Scale administered by a physiotherapist.
Measured: Through study completion, about one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start1 Jan 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360487
- Sponsor's protocol ID
- FBMEM
- Status last verified
- Oct 2018
- First submitted
- 17 Nov 2017
- Last updated
- 11 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35499744Silva 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.
PubMed 32255785
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03360487
- Acronym / sponsor ID
- FBMEM
- Conditions
- Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 4 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sham photobiomodulation in the sublingual region | Sham comparator | Radiation: Photobiomodulation in the sublingual regionA 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. |
| Photobiomodulation in the sublingual region | Active comparator | Radiation: Photobiomodulation in the sublingual regionA disposable plastic wrap will cover the application pen for the purposes of hygiene, and the region will be irradiated for 10 minutes. |
| Sham photobiomodulation along the spinal cord | Sham comparator | Radiation: Photobiomodulation in the spinal cordTranscutaneous 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). |
| Photobiomodulation along the spinal cord | Active comparator | Radiation: Photobiomodulation in the spinal cordTranscutaneous 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 | Sham comparator | Radiation: Photobiomodulation in the radial arteryIntravascular 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. |
| Photobiomodulation in the radial artery | Active comparator | Radiation: Photobiomodulation in the radial arteryIntravascular 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- Other autoimmune diseases;
- Neoplasias;
- Heart failure;
- Respiratory failure;
- Renal insufficiency;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation in the sublingual regionIn 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 sublingual region, Sham photobiomodulation in the sublingual region |
| Photobiomodulation in the spinal cordTranscutaneous 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 along the spinal cord, Sham photobiomodulation along the spinal cord |
| Photobiomodulation in the radial arteryIntravascular 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, Sham Photobiomodulation in the radial artery |
Primary outcome
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.
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.
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.
1 secondary outcome
EDSS
Time frame: Through study completion, about one year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Derived from this study: PubMed 35499744Silva 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.
- Derived from this study: PubMed 32255785Silva 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Photobiomodulation in the sublingual region, Photobiomodulation in the spinal cord and Photobiomodulation in the radial artery in people with Multiple Sclerosis, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tamiris da Silva, MS (1125571502, tamiris.slv@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidative stress (time frame: Through study completion, about one year.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03360487, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.