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

NCT05959772 | Unknown DMC

• 1 other identifier: 5.903.248
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease; Pain; Photobiomodulation

Keywords

Photobiomodulation; Parkinson Disease; Pain; rsfRMI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• McGuill Pain Questionnaire

  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)

  This questionnaires will be applied before the treatment (baseline) and again after the end of the treatment (five weeks- from the first procedure).

Study Arms (2)

Photobiomodulation ON

EXPERIMENTAL

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

Photobiomodulation Off

PLACEBO COMPARATOR

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

Radiation: Photobiomodulation

Interventions

Photobiomodulation 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 ON; Photobiomodulation Off

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead
• University of Maryland, Baltimore: collaborator

Study Sites (2)

Mara Evany de Oliveira Silva

São Paulo, 05508-900, Brazil

RECRUITING

University of São Paulo

São Paulo, 05508-900, Brazil

RECRUITING

Related Links

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

MeSH Terms

Conditions

Parkinson Disease; Pain

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Mara 55 Evany de Oliveira Silva, Doctor

CONTACT

+55 11 3091-8452; maraevany@hotmail.com

Marucia 55 Chacur, Mentor

CONTACT

+55 11 3091-8452; chacurm@icb.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: meoliveirasilva Postdoctoral student

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 25, 2023
• Study Start: June 16, 2023
• Primary Completion: October 25, 2023
• Study Completion: June 30, 2025
• Last Updated: July 25, 2023

Record last verified: 2023-07

Locations

BR (2)