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

July 17, 2023 updated by: Mara Evany de Oliveira Silva, University of Sao Paulo

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Mara 55 Evany de Oliveira Silva, Doctor
  • Phone Number: Brazil +55 11 3091-8452
  • Email: maraevany@hotmail.com

Study Contact Backup

  • Name: Marucia 55 Chacur, Mentor
  • Phone Number: Brazil +55 11 3091-8452
  • Email: chacurm@icb.usp.br

Study Locations

  • Brazil
      • São Paulo, Brazil, 05508-900
        • Recruiting
        • Mara Evany de Oliveira Silva
        • Contact:
          • Mara 55 Evany de Oliveira Silva, Study principal investigatio
          • Phone Number: Brazil 11 3091-8452
          • Email: maraevany@hotmail.com
        • Contact:
      • São Paulo, Brazil, 05508-900
        • Recruiting
        • University of Sao Paulo
        • Contact:
        • Contact:
          • Mara 55 Evany de Oliveira Silva, Study principal investigation
          • Phone Number: Brazil 11 3091-8452
          • Email: maraevany@hotmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Radiation: 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
Placebo Comparator: Photobiomodulation Off
Photobiomodulation Placebo Group Appication of Photobiomodulatio off, time between 4 and 9 minutes, to 5 weeks
Radiation: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Numerical Scale
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.
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.
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
McGuill Pain Questionnaire
Time Frame: This questionaire will be aplyed before any procedure or intervention (baseline) and again after five weeks from the first procedure.
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.
This questionaire will be aplyed before any procedure or intervention (baseline) and again after five weeks from the first procedure.
King's Parkinson's Disease Pain Scale (KPPS)
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).
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
This questionnaires will be applied before the treatment (baseline) and again after the end of the treatment (five weeks- from the first procedure).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Maryland, Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 16, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 25, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5.903.248

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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