Transcranial Photobiomodulation as a Therapy for Patients With Parkinson's Disease: Relationship Between Pain and Brain Functional Connectivity (FBM)

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

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-16

Study Completion Date

2025-06-30

Brief Summary

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Parkinson's disease is a progressive and degenerative neurological movement disorder that affects thousands of people. The disease is characterized by presenting motor and non-motor symptoms, as the disease progresses, it becomes more disabling, making it impossible for the individual to perform simple tasks. A non-motor symptom increasingly reported by patients and undertreated in clinical practice is pain. During the past few decades, possible neural substrates of pain have been studied extensively, resulting in a potential network of connected brain areas that are believed to underlie pain processing and experience. There is no definitive consensus on all areas involved in such a pain network; however, pain-related regions consistently found across all studies include the thalamus, anterior cingulate cortex (ACC), posterior and anterior insula, amygdala, prefrontal cortex (PFC), secondary somatosensory cortex (IBS), and periaqueductal gray (PAG). With the aim of helping to improve the painful condition, non-pharmacological therapies have been studied, and one of them is phototherapy, a non-invasive method used by several areas of health, which has been shown to be increasingly effective in the treatment of decreased pain sensitivity. The present study aims to evaluate the effects of transcranial photobiomodulation in patients with Parkinson's disease. This is a randomized study, in which investigators will analyze the effect of FBM on pain control and on magnetic resonance images to better elucidate the connectivities of pain areas. Afterwards, the researchers will carry out a better elaboration on the treatments of individuals diagnosed with Parkinson's disease, the researchers will evaluate the pain through questionnaires, and the researchers will also evaluate the motor cognitive capacity of these patients before and after the therapy.

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Detailed Description

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1\. Objectives

General:

Evaluate the effects of applying transcranial photobiomodulation in patients with Parkinson's disease who show increased pain intensity when off levodopa.

Specific:

* Evaluate pain intensity using the Visual Analog Scale (VAS) before and after transcranial photobiomodulation sessions;
* Evaluate the sensitive, discriminative, affective-motivational and cognitive dimensions of pain by applying the McGill questionnaire before and after the end of treatment;
* Identify and grade pain by applying the King's Parkinson's Disease Pain Scale (KPPS) before and after treatment;
* Evaluate cognitive motor behavior using the Timed Up Go (TUG) and TUG Dual Task test at the beginning and end of treatment;
* Analysis of brain connectivities related to pain (connectivities of the thalamus, right cingulate cortex, striatum (caudate nucleus and putamen), and substantia nigra) using Functional Magnetic Resonance Imaging at rest before and after the end of treatment

Conditions

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Parkinson Disease Pain Photobiomodulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The study will be conducted by the main researcher, responsible for the evaluation and application of the questionnaires, who will not be aware of which group will be the experimental and/or placebo. The study will have a collaborator trained in the application of phototherapy, also without prior knowledge of both groups

Study Groups

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Photobiomodulation ON

Photobiomodulation therapy Group PBM Application of Photobiomodulation exposure time between 4 and 9 minutes, application of PBM with treatment time of 5 weeks

Group Type EXPERIMENTAL

Photobiomodulation

Intervention Type RADIATION

Light-Aid equipment from Bright Photomedicine-Brasil will be used, with an 850 nm Arsenide, Gallium and Aluminum (AsGaAl) LED. Exposure time between 4 and 9 minutes; radiant exposure of approximately 41mW/cm2; with 8 "clusters" in each session. Two tapes containing four "clusters" each will be arranged, and each cluster contains 25 led's adding up to a total of one hundred (100) led's arranged in each on the tape

Photobiomodulation Off

Photobiomodulation Placebo Group Appication of Photobiomodulatio off, time between 4 and 9 minutes, to 5 weeks

Group Type PLACEBO_COMPARATOR

Photobiomodulation

Intervention Type RADIATION

Light-Aid equipment from Bright Photomedicine-Brasil will be used, with an 850 nm Arsenide, Gallium and Aluminum (AsGaAl) LED. Exposure time between 4 and 9 minutes; radiant exposure of approximately 41mW/cm2; with 8 "clusters" in each session. Two tapes containing four "clusters" each will be arranged, and each cluster contains 25 led's adding up to a total of one hundred (100) led's arranged in each on the tape

Interventions

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Photobiomodulation

Light-Aid equipment from Bright Photomedicine-Brasil will be used, with an 850 nm Arsenide, Gallium and Aluminum (AsGaAl) LED. Exposure time between 4 and 9 minutes; radiant exposure of approximately 41mW/cm2; with 8 "clusters" in each session. Two tapes containing four "clusters" each will be arranged, and each cluster contains 25 led's adding up to a total of one hundred (100) led's arranged in each on the tape

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Patients with Hoehn \& Yahr 3
* Pain from Parkinson's disease
* Walk independently
* Ability to understand simple command

Exclusion Criteria

* Wheelchair users
* Severe postural instability
* Severe cognitive impairment
* Contraindications for MRI, such as dyskinesia or deep brain stimulation

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No