Sublingual Photobiomodulation in Parkinson's Disease

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04028817
• Other study ID #: sublingual photobiomodulation
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 10, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: June 2020
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 30, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• photobiomodulation
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 photobiomodulation
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.

Locations

Country	Name	City	State
Brazil	Daysi da Cruz Tobelem	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day