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临床试验/NCT04852536
NCT04852536Unknown不适用

EEG as Predictor of Effectiveness of HD-tDCS in Treatment of Neuropathic Pain After Brachial Plexus Injury: Machine Learning Approach

Federal University of Paraíba1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年6月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Pain intensity measured using Numerical Pain Scale

研究概览

简要总结

Contextualization: Neuropathic pain is a complication present in the clinical picture of patients with traumatic Brachial Plexus injury (BPI). It is characterized by high intensity, severity and refractoriness to clinical treatments, resulting in high disability and loss of quality of life. Due to loss of afferent entry, it causes cortical and subcortical alterations and changes in somatotopic representation, from inadequate plastic adaptations in the Central and Peripheral Nervous System, one of the therapies with potential benefit in this population is the Transcranial High Definition Continuous Current Stimulation (HD-tDCS). Thus, by using connectivity-based response prediction and machine learning, it will allow greater assurance of efficiency and optimization of the application of this therapy, being directed to patients with greater potential to benefit from the application of this approach. Objective: Using connectivity-based prediction and machine learning, this study aims to assess whether baseline EEG related characteristics predict the response of patients with neuropathic pain after BPI to the effectiveness of HD-tDCS treatment. Materials and methods: A quantitative, applied, exploratory, open-label response prediction study will be conducted from data acquired from a pilot, triple-blind, cross-over, placebo-controlled, randomized clinical trial investigating the efficacy of applying HD-tDCS to patients with neuropathic brachial plexus trauma pain. Participants will be evaluated for eligibility and then randomly allocated into two groups to receive the active HD-tDCS or simulated HD-tDCS. The primary outcome will be pain intensity as measured by the numerical pain scale. Participants will be invited to participate in an EEG study before starting treatment. Clinical improvement labels used for machine learning classification will be determined based on data obtained from the clinical trial (baseline and post-treatment evaluations). The hypothesis adopted in this study is that the response prediction model constructed from EEG frequency band pattern data collected at baseline will be able to identify responders and non-responders to HD-tDCS treatment.

详细描述

Using connectivity-based prediction and machine learning, the objective is to assess whether characteristics related to baseline EEG predict the response of patients with neuropathic pain after BPI to the effectiveness of HD-tDCS treatment. An observational, retrospective cohort study will be carried out, of predictive response with a quantitative approach, of an applied nature, of an exploratory and open-label type, related to the efficacy of HD-tDCS4x1 in patients with neuropathic pain due to BPI, from an analysis of data obtained from a pilot, placebo-controlled, triple-blind, randomized, crossover type clinical trial, in accordance with the CONSORT guidelines, which will investigate the effectiveness of treatment with HD-tDCS.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Age over 18 years;
  • Moderate to severe pain score according to the Numerical Pain Scale (4-10);
  • Persistent pain and refractory to clinical treatment for at least 3 months;
  • Appropriate pharmacological treatment for pain for at least 1 month before the start of the study;
  • Not presenting contraindications for Non-Invasive Brain Stimulation;
  • Absence of concomitant diseases of the Central Nervous Sistem or Peripheral Nervous Sistem.

排除标准

  • Failure to sign the informed consent form;
  • Missing two consecutive or three alternate sessions during treatment;
  • Developing a disabling condition that prevents further participation in the study

结局指标

主要结局

Pain intensity measured using Numerical Pain Scale

时间窗: 1 week (5 sessions)

Identification of responders and non-responders to treatment with HD-tDCS, according to the scores obtained by the patients response on the Numerical Pain Scale recorded immediately after the treatment, thus determining the functional labels for processing machine learning models. This instrument measures the intensity of pain, consisting of 11 points (0-10), 0 being counted for no pain and 10 for the worst possible pain. A reduction of two points or by 30% will be considered a clinically important minimum difference (DWORKIN et al., 2008).

Neurophysiological characteristics and biomarkers recorded by EEG

时间窗: One month

The EEG data will be retrospectively examined by comparing the two groups (responders and non-responders), identifying possible neurophysiological characteristics and biomarkers related to frequency bands and connectivity that could be characterized as possible markers of response to treatment, predicting which are most likely to respond. The examination of the cortical electrical activity using the EEG tool (BrainVision actiCHamp, Herrsching, Germany), with 32 silver chloride electrodes fixed according to the International System 10-20, by means of an adjustable cap, containing holes that will allow the contact of the electrode with the scalp. The prefrontal, frontal, parietal, temporal and occipital regions will be monitored bilaterally (Fp1, Fp2, F3, F4), temporal (F7, F8, T3, T4, T5, T6), central (C3, C4, Cz) and parieto-occipital (P3, P4, P7, P8, O1, O2), in the condition of silence, with eyes closed, for five minutes each, totaling 10 minutes of collection for each participant.

次要结局

未报告次要终点

研究者

发起方
Federal University of Paraíba
申办方类型
Other
责任方
Principal Investigator
主要研究者

Suellen Marinho Andrade

Principal Investigator and Professor

Federal University of Paraíba

研究点 (1)

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