Back to resultsSublingual Photobiomodulation in Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
photobiomodulation
placebo photobiomodulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring parkinson's disease, Photobiomodulation, Inflammation, Oxidative stress
Eligibility Criteria
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.
Sites / Locations
- Daysi da Cruz Tobelem
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
group treatment
group control
Arm Description
This group will receive laser treatment combined with low intensity exercises
This group will receive placebo laser treatment combined with low intensity exercises
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04028817
First Posted
July 19, 2019
Last Updated
June 11, 2020
Sponsor
University of Nove de Julho
1. Study Identification
Unique Protocol Identification Number
NCT04028817
Brief Title
Sublingual Photobiomodulation in Parkinson's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 10, 2020 (Anticipated)
Primary Completion Date
August 10, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
parkinson's disease, Photobiomodulation, Inflammation, Oxidative stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group treatment
Arm Type
Experimental
Arm Description
This group will receive laser treatment combined with low intensity exercises
Arm Title
group control
Arm Type
Placebo Comparator
Arm Description
This group will receive placebo laser treatment combined with low intensity exercises
Intervention Type
Device
Intervention Name(s)
photobiomodulation
Other Intervention Name(s)
low level laser therapy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
placebo photobiomodulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
10-meter walk test
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Daysi da Cruz Tobelem
City
São Paulo
ZIP/Postal Code
04119010
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daysi da Cruz Tobelem, Master
Phone
55 (11) 982556767
Email
to.belin.he@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Sublingual Photobiomodulation in Parkinson's Disease
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