Sublingual Photobiomodulation in Parkinson's Disease

Not Applicable

• Conditions: Parkinson Disease
• Interventions: Device: placebo photobiomodulation; Device: photobiomodulation

• Registration Number: NCT04028817
• Lead Sponsor: University of Nove de Julho

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-19
• Study First Submitted QC: 2019-07-19
• Study First Posted: 2019-07-23
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-11
• Last Update Posted: 2020-06-12
• Study Start: 2020-09-10
• Primary Completion: 2021-08-10
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group control	placebo photobiomodulation	This group will receive placebo laser treatment combined with low intensity exercises
group treatment	photobiomodulation	This group will receive laser treatment combined with low intensity exercises

Primary Outcome Measures

Name	Time	Method
10-meter walk test	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.

Trial Locations

Locations (1)

Daysi da Cruz Tobelem; 🇧🇷 São Paulo, Brazil