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

Pain Clinical Trial

— FBM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05959772
• Other study ID #: 5.903.248
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: July 2023
• Source: University of Sao Paulo
• Contact: Mara 55 Evany de Oliveira Silva, Doctor
• Phone: +55 11 3091-8452
• Email: maraevany[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: June 30, 2025
• Est. primary completion date: October 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Parkinson Disease
• Photobiomodulation

Intervention

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

Locations

Country	Name	City	State
Brazil	Mara Evany de Oliveira Silva	São Paulo
Brazil	University of São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	University of Maryland, Baltimore

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	This questionaire will be aplyed before any procedure or intervention (baseline) and again after five weeks from the first procedure.
Secondary	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	This questionnaires will be applied before the treatment (baseline) and again after the end of the treatment (five weeks- from the first procedure).

External Links

•   Abnormal connectivity model of raphe nuclei with sensory-associated cortex in Parkinson's disease with chronic pain
•   Significant Improvement in Cognition in Mild to Moderately Severe Dementia Cases Treated with Transcranial Plus Intranasal Photobiomodulation: Case Series Report
•   The Parkinson disease pain classification system: results from an international mechanism-based classification approach