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Sublingual Photobiomodulation in Parkinson's Disease

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04028817
Enrollment
40
Registered
2019-07-23
Start date
2020-09-10
Completion date
2021-12-30
Last updated
2020-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

parkinson's disease, Photobiomodulation, Inflammation, Oxidative stress

Brief 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.

Interventions

DEVICEphotobiomodulation

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.

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.

Sponsors

University of Nove de Julho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
10-meter walk test1 dayThis 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026