Parkinson DiseaseNCT04028817
Sublingual Photobiomodulation in Parkinson's Disease
A study testing photobiomodulation in people with Parkinson Disease, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
This study evaluates the use of photobiomodulation in the treatment of patients with Parkinson's disease. Half of participants will receive treatment with low level laser therapy and exercises in combination, while the other half will receive a placebo laser combined with exercises. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Sep 2020to 30 Dec 2021
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with Parkinson's disease diagnosed with the criteria of the UK Parkinsons' Disease Society Brain Bank Clinical Diagnostic Criteria
- In the stages I to III of the disease according to Hoehn \& Yahr's Parkinson's disease staging scale - modified;
- Individuals of both sexes,
- with more than 50 years
- who sign the informed consent form
Who cannot join
- patients who present some adverse event during the development of the study,
- Who have another associated neurodegenerative disease,
- Have blood dyscrasia, HIV, heart failure, hepatic or renal insufficiency, infections, neoplasias, respiratory disorders, hypophysis and hypothalamus problems.
- Who fail to understand or perform procedures correctly because of physical and mental limitations.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Daysi da Cruz Tobelem
São Paulo, 04119010
Daysi da Cruz Tobelem, Master, 55 (11) 982556767, to.belin.he@hotmail.com
About this study
Official title: Evaluation of the Concentrations of Inflammatory, Protein and Oxidative Biomarkers of Parkinson's Disease After Photobiomodulation From Sublingual Laser Application - Clinical, Randomized and Blind Test
This study evaluates the use of photobiomodulation in the treatment of patients with Parkinson's disease. Half of participants will receive treatment with low level laser therapy and exercises in combination, while the other half will receive a placebo laser combined with exercises.
- Conditions
- Parkinson Disease
- Being tested
- photobiomodulation, placebo photobiomodulation
- Keywords
- parkinson's disease, Photobiomodulation, Inflammation, Oxidative stress
- Medical subject headings
- Parkinson Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photobiomodulationDevice
Also called low level laser therapy
the intervention will occur twice a week, 18 sessions will be performed, during the sessions will be applied sublingual laser in a single point, with wavelength of 808 nm, diameter of 0.4 cm, with irradiance of 0.8 w / cm2, for 360 s, the laser applied will be of continuous wave with energy of 36J.
placebo photobiomodulationDevice
the intervention will occur twice a week, 18 sessions will be performed, during the sessions will be applied a placebo sublingual laser for 360 s.
| Study group | Role | What they receive |
|---|---|---|
| group treatment | Experimental | This group will receive laser treatment combined with low intensity exercises Receives: Device: photobiomodulation |
| group control | Placebo comparator | This group will receive placebo laser treatment combined with low intensity exercises Receives: Device: placebo photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-meter walk test
This evaluation will be carried out from the application of the tem meter walk test. The test will be performed in a straight hall, with a line 14 meters long. The first 2 meters marked, will be provided so that the patient reaches the usual walking speed, and the last 2 meters will be provided for the patient to decelerate and stop. At the start of the test, patients will receive walking guidance at a comfortable pace.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start10 Sep 2020 (estimated)
- Primary completion10 Aug 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daysi Tobelem, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028817
- Sponsor's protocol ID
- sublingual photobiomodulation
- Status last verified
- Jun 2020
- First submitted
- 19 Jul 2019
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Concentrations of Inflammatory, Protein and Oxidative Biomarkers of Parkinson's Disease After Photobiomodulation From Sublingual Laser Application - Clinical, Randomized and Blind Test
- ClinicalTrials.gov ID
- NCT04028817
- Acronym / sponsor ID
- sublingual photobiomodulation
- Conditions
- Parkinson Disease
- Keywords
- parkinson's disease, Photobiomodulation, Inflammation, Oxidative stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 10 Sep 2020 (estimated)
- Primary completion
- 10 Aug 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 23 Jul 2019 (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.
This study evaluates the use of photobiomodulation in the treatment of patients with Parkinson's disease. Half of participants will receive treatment with low level laser therapy and exercises in combination, while the other half will receive a placebo laser combined with exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group treatment | Experimental | Device: photobiomodulationThis group will receive laser treatment combined with low intensity exercises |
| group control | Placebo comparator | Device: placebo photobiomodulationThis group will receive placebo laser treatment combined with low intensity exercises |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with Parkinson's disease diagnosed with the criteria of the UK Parkinsons' Disease Society Brain Bank Clinical Diagnostic Criteria
- In the stages I to III of the disease according to Hoehn \& Yahr's Parkinson's disease staging scale - modified;
- Individuals of both sexes,
- with more than 50 years
- who sign the informed consent form
Key exclusion criteria (4 listed)
- patients who present some adverse event during the development of the study,
- Who have another associated neurodegenerative disease,
- Have blood dyscrasia, HIV, heart failure, hepatic or renal insufficiency, infections, neoplasias, respiratory disorders, hypophysis and hypothalamus problems.
- Who fail to understand or perform procedures correctly because of physical and mental limitations.
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 |
|---|---|---|
| photobiomodulationAlso: low level laser therapythe intervention will occur twice a week, 18 sessions will be performed, during the sessions will be applied sublingual laser in a single point, with wavelength of 808 nm, diameter of 0.4 cm, with irradiance of 0.8 w / cm2, for 360 s, the laser applied will be of continuous wave with energy of 36J. | Device | group treatment |
| placebo photobiomodulationthe intervention will occur twice a week, 18 sessions will be performed, during the sessions will be applied a placebo sublingual laser for 360 s. | Device | group control |
Primary outcome
10-meter walk test
Time frame: 1 day
This evaluation will be carried out from the application of the tem meter walk test. The test will be performed in a straight hall, with a line 14 meters long. The first 2 meters marked, will be provided so that the patient reaches the usual walking speed, and the last 2 meters will be provided for the patient to decelerate and stop. At the start of the test, patients will receive walking guidance at a comfortable pace.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 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 study testing photobiomodulation in people with Parkinson Disease, 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 5 inclusion and 4 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 12 Jun 2020. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10-meter walk test (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2020.