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临床试验/NCT05959772
NCT05959772招募中不适用

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

University of Sao Paulo4 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2023年6月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
82
试验地点
4
主要终点
Visual Numerical Scale

研究概览

简要总结

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.

详细描述

  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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Visual Numerical Scale

时间窗: 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.

次要结局

  • 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).)
  • McGuill Pain Questionnaire(This questionaire will be aplyed before any procedure or intervention (baseline) and again after five weeks from the first procedure.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mara Evany de Oliveira Silva

meoliveirasilva Postdoctoral student

University of Sao Paulo

研究点 (4)

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