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临床试验/NCT03744897
NCT03744897已完成不适用

Effect of Hypnosis Combined to Transcranial Direct Stimulation in Cortical Activity and Pain Perception in Healthy Females

Hospital de Clinicas de Porto Alegre2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2017年7月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Change in Theta waves

研究概览

简要总结

Pain is a public health condition, which causes great functional disability. Its consequences pervade the personal and social life of the patient, leading to significant changes in their interpersonal relationships, including work, family and social spheres, reducing the ability to perform daily activities. Conventional treatment modalities have been show a very poor therapeutic response, in that most individuals end up becoming polymedicated patients and refractory to treatment. Among non-pharmacological techniques with promising analgesic effects it includes both the hypnotic analgesia and the transcranial stimulation of direct current (tDCS).

详细描述

Introduction

Pain is a public health condition, which causes great functional disability. Its consequences pervade the personal and social life of the patient, leading to significant changes in their interpersonal relationships, including work, family and social spheres, reducing the ability to perform daily activities. Conventional treatment modalities have been show a very poor therapeutic response, in that most individuals end up becoming polymedicated patients and refractory to treatment. Among non-pharmacological techniques with promising analgesic effects it includes both the hypnotic analgesia and the transcranial stimulation of direct current (tDCS). Objective: To evaluate the synergistic effect of hypnotic analgesia associated with tDCS under metabolites parameters and pain levels in healthy individuals before a nociceptive stimulation pattern. Methods: it will be performed a blinded crossover sham controlled randomized clinical trial. It will be included 32 woman healthy subjects, Susceptible to the hypnosis technique according to the Scale of Hypnotic Susceptibility (WSGC) Scale of Hypnotic Scale score. aged 18 to 65. They will be allocated in one of the following groups: active tDCS + hypnotic analgesia, sham tDCS + hypnotic analgesia, hypnotic analgesia and tDCS . After a 7 days interval, the groups will be crossed in order to receive the opposite intervention of the first week. The primary endpoints will be the electrophysiological brain parameters, such as changes in the Theta, Alpha and Gamma waves, as measured by EEG. The secondary endpoints will be the level of pain, measured against nociceptive induced by the cold test and stimuli standardized pressure through algometry pressure and power down system modulatory pain, pain using the subject test - CPM - task. The intra and inter-group comparisons will be made by means of two-way ANOVA followed by Bonferroni. A p significance level of <0.05 was established. Expected results: This study hypothesizes that a synergistic effect of analgesic techniques in pain levels in healthy subjects compared to isolated character.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Subjects are blinded to wether group they will be allocated Assessor will be blinded and the investigator not involved in subjects assessment will perform the hypnosis.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •11 years of schooling
  • •12 cut-off at Waterloo-Stanford Group C (WSGC)

排除标准

  • •hearing loss subjects
  • •formal contraindication to tDCS (pregnancy, deep brain device, epilepsy, seizure)

研究组 & 干预措施

Hypnotic analgesia

Experimental

Intervention:

  • Subjects will receive hypnotic analgesia

干预措施: Hypnotic analgesia (Behavioral)

a-tDCS

Experimental

Intervention: transcranial direct current stimulation - tDCS

  • active tDCS stimulation
  • montage: bilateral DLPFC anodal/left and cathodal/right
  • current:2 milliamps
  • time: 20 minutes

干预措施: Hypnotic analgesia (Behavioral)

a-tDCS

Experimental

Intervention: transcranial direct current stimulation - tDCS

  • active tDCS stimulation
  • montage: bilateral DLPFC anodal/left and cathodal/right
  • current:2 milliamps
  • time: 20 minutes

干预措施: s-tDCS (Device)

s-tDCS

Sham Comparator

Sham comparator: transcranial direct current stimulation - tDCS

  • sham tDCS stimulation
  • montage: bilateral DLPFC anodal/left and cathodal/right
  • current: 0 milliamps
  • time: 20 minutes

干预措施: a-tDCS (Device)

s-tDCS

Sham Comparator

Sham comparator: transcranial direct current stimulation - tDCS

  • sham tDCS stimulation
  • montage: bilateral DLPFC anodal/left and cathodal/right
  • current: 0 milliamps
  • time: 20 minutes

干预措施: Hypnotic analgesia + a-tDCS (Other)

Hypnotic analgesia + a-tDCS

Experimental

Intervention:

  • hypnotic analgesia
  • active tDCS stimulation
  • montage: bilateral DLPFC anodal/left and cathodal/right
  • current:2 milliamps
  • time: 20 minutes

干预措施: Hypnotic analgesia + a-tDCS (Other)

结局指标

主要结局

Change in Theta waves

时间窗: 60 minutes

Variations in the theta waves power from post to pre-intervention using electroencephalography during a cold pressor test

Change in Alpha waves

时间窗: 60 minutes

Variations in the alpha waves power from post to pre-intervention using electroencephalography during a cold pressor test

次要结局

  • Change in delta waves(60 minutes)
  • Change in Heat thermal threshold(60 minutes)
  • Change in Heat pain threshold(60 minutes)
  • Change in Heat pain tolerance(60 minutes)
  • Change in Cold Pressor Test 0 to 1 degree Celsius - time(60 minutes)
  • Change in Cold Pressor Test 10 degree Celsius - pain(60 minutes)
  • Change in beta waves(60 minutes)
  • Change in gamma waves(60 minutes)
  • Change in Numeric pain scale during CPM task(60 minutes)
  • Change in Cold Pressor Test 10 degree Celsius - time(60 minutes)

研究者

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

Wolnei Caumo

Professor of Surgery Department - School of Medicine - Head of HCPA Pain and Palliative Care Outpatient

Hospital de Clinicas de Porto Alegre

研究点 (2)

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