An interventional study of Photobiomodulation in Parkinson Disease, Pain and Photobiomodulation, sponsored by University of Sao Paulo. Recruiting at 2 sites in Brazil. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-07-25.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
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.
General:
Evaluate the effects of applying transcranial photobiomodulation in patients with Parkinson's disease who show increased pain intensity when off levodopa.
Specific:
4,487 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.
This study's planned enrollment of 82 is above the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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 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
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.
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.
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.
Time frame: 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)
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).
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University of Sao Paulo