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

Primary Purpose

Parkinson Disease, Pain, Photobiomodulation

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Photobiomodulation
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Photobiomodulation, Parkinson Disease, Pain, rsfRMI

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mara Evany de Oliveira SilvaRecruiting
  • University of São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Photobiomodulation ON

Photobiomodulation Off

Arm Description

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

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

Outcomes

Primary Outcome Measures

Visual Numerical Scale
Visual Numerical Scale, a is an instrument for the qualitative assessment of pain intensity. It consists of a line numbered from zero ( 0 ) which represents total absence of pain to ten (10) which represents the worst pain the individual can feel. This scale will be applied before the first session and before the start of each transcranial phototherapy session.

Secondary Outcome Measures

McGuill Pain Questionnaire
Evaluate the effects of applying transcranial photobiomodulation in patients with Parkinson's disease who show increased pain intensity when off levodopa. One of the most used questionnaires for measuring pain. It allows us to identify different types of pain, being considered one of the best to assess the sensitive-discriminative, affective-motivational and cognitive dimension of pain.
King's Parkinson's Disease Pain Scale (KPPS)
First specific scale to assess pain in individuals with Parkinson's disease. It comprises 14 items divided into 7 domains, and each item is scored by the severity of the pain multiplied by the frequency the patient feels

Full Information

First Posted
June 28, 2023
Last Updated
July 17, 2023
Sponsor
University of Sao Paulo
Collaborators
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT05959772
Brief Title
Transcranial Photobiomodulation as a Therapy for Patients With Parkinson's Disease: Relationship Between Pain and Brain Functional Connectivity (FBM)
Acronym
FBM
Official Title
Transcranial Photobiomodulation as a Therapy for Patients With Parkinson's Disease: Relationship Between Pain and Brain Functional Connectivity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2023 (Actual)
Primary Completion Date
October 25, 2023 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Pain, Photobiomodulation
Keywords
Photobiomodulation, Parkinson Disease, Pain, rsfRMI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Photobiomodulation ON
Arm Type
Experimental
Arm Description
Photobiomodulation therapy Group PBM Application of Photobiomodulation exposure time between 4 and 9 minutes, application of PBM with treatment time of 5 weeks
Arm Title
Photobiomodulation Off
Arm Type
Placebo Comparator
Arm Description
Photobiomodulation Placebo Group Appication of Photobiomodulatio off, time between 4 and 9 minutes, to 5 weeks
Intervention Type
Radiation
Intervention Name(s)
Photobiomodulation
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual Numerical Scale
Description
Visual Numerical Scale, a is an instrument for the qualitative assessment of pain intensity. It consists of a line numbered from zero ( 0 ) which represents total absence of pain to ten (10) which represents the worst pain the individual can feel. This scale will be applied before the first session and before the start of each transcranial phototherapy session.
Time Frame
The first scale measuremente is our First day (baseline- before any procedure). All other measurement will be made each 72 hours after the beginning of the treatment with a total of 11 days.
Secondary Outcome Measure Information:
Title
McGuill Pain Questionnaire
Description
Evaluate the effects of applying transcranial photobiomodulation in patients with Parkinson's disease who show increased pain intensity when off levodopa. One of the most used questionnaires for measuring pain. It allows us to identify different types of pain, being considered one of the best to assess the sensitive-discriminative, affective-motivational and cognitive dimension of pain.
Time Frame
This questionaire will be aplyed before any procedure or intervention (baseline) and again after five weeks from the first procedure.
Title
King's Parkinson's Disease Pain Scale (KPPS)
Description
First specific scale to assess pain in individuals with Parkinson's disease. It comprises 14 items divided into 7 domains, and each item is scored by the severity of the pain multiplied by the frequency the patient feels
Time Frame
This questionnaires will be applied before the treatment (baseline) and again after the end of the treatment (five weeks- from the first procedure).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mara 55 Evany de Oliveira Silva, Doctor
Phone
+55 11 3091-8452
Ext
Brazil
Email
maraevany@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marucia 55 Chacur, Mentor
Phone
+55 11 3091-8452
Ext
Brazil
Email
chacurm@icb.usp.br
Facility Information:
Facility Name
Mara Evany de Oliveira Silva
City
São Paulo
ZIP/Postal Code
05508-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mara 55 Evany de Oliveira Silva, Study principal investigatio
Phone
11 3091-8452
Ext
Brazil
Email
maraevany@hotmail.com
First Name & Middle Initial & Last Name & Degree
Marucia 55 Chacur, Mentor
Phone
11 3091-8452
Ext
Brazil
Email
chacurm@icb.usp.br
Facility Name
University of São Paulo
City
São Paulo
ZIP/Postal Code
05508-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mara 55 Evany de Oliveira Silva, Study principal investigation
Phone
11 3091-8452
Ext
Brazil
Email
maraevany@hotmail.com
First Name & Middle Initial & Last Name & Degree
Marucia 55 Chacur, Mentor
Phone
11 3091-8452
Ext
Brazil
Email
chacurm@icb.usp.br

12. IPD Sharing Statement

Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7977616/pdf/jop-162-1201.pdf
Description
The Parkinson disease pain classification system: results from an international mechanism-based classification approach
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5568598/pdf/pho.2016.4227.pdf
Description
Significant Improvement in Cognition in Mild to Moderately Severe Dementia Cases Treated with Transcranial Plus Intranasal Photobiomodulation: Case Series Report
URL
https://pubmed.ncbi.nlm.nih.gov/35000015/
Description
Abnormal connectivity model of raphe nuclei with sensory-associated cortex in Parkinson's disease with chronic pain

Learn more about this trial

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

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