Sublingual Photobiomodulation in Parkinson's Disease

NCT ID: NCT04028817

Last Updated: 2020-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-10

Study Completion Date

2021-12-30

Brief Summary

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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

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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group treatment

This group will receive laser treatment combined with low intensity exercises

Group Type EXPERIMENTAL

photobiomodulation

Intervention Type DEVICE

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.

group control

This group will receive placebo laser treatment combined with low intensity exercises

Group Type PLACEBO_COMPARATOR

placebo photobiomodulation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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low level laser therapy

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nove de Julho

OTHER

Sponsor Role lead

Responsible Party

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Daysi Tobelem

Master degree

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Daysi da Cruz Tobelem

São Paulo, , Brazil

Site Status

Countries

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Brazil

Facility Contacts

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Daysi da Cruz Tobelem, Master

Role: primary

55 (11) 982556767

Other Identifiers

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sublingual photobiomodulation

Identifier Type: -

Identifier Source: org_study_id

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