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脑机接口缓解慢性化疗诱导的周围神经病:一项随机、双盲、安慰剂对照试验。

Brain-computer interface relieves chronic chemotherapy-induced peripheral neuropathy: A randomized, double-blind, placebo-controlled trial.

机构信息

Department of Palliative, Rehabilitation, and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.

Department of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.

出版信息

Cancer. 2024 Jan;130(2):300-311. doi: 10.1002/cncr.35027. Epub 2023 Sep 21.

Abstract

BACKGROUND

Chemotherapy-induced peripheral neuropathy (CIPN) includes negative sensations that remain a major chronic problem for cancer survivors. Previous research demonstrated that neurofeedback (a closed-loop brain-computer interface [BCI]) was effective at treating CIPN versus a waitlist control (WLC). The authors' a priori hypothesis was that BCI would be superior to placebo feedback (placebo control [PLC]) and to WLC in alleviating CIPN and that changes in brain activity would predict symptom report.

METHODS

Randomization to one of three conditions occurred between November 2014 and November 2018. Breast cancer survivors no longer in treatment were assessed at baseline, at the end of 20 treatment sessions, and 1 month later. Auditory and visual rewards were given over 20 sessions based on each patient's ability to modify their own electroencephalographic signals. The Pain Quality Assessment Scale (PQAS) at the end of treatment was the primary outcome, and changes in electroencephalographic signals and 1-month data also were examined.

RESULTS

The BCI and PLC groups reported significant symptom reduction. The BCI group demonstrated larger effect size differences from the WLC group than the PLC group (mean change score: BCI vs. WLC, -2.60 vs. 0.38; 95% confidence interval, -3.67, -1.46 [p = .000; effect size, 1.07]; PLC, -2.26; 95% confidence interval, -3.33, -1.19 [p = .001 vs. WLC; effect size, 0.9]). At 1 month, symptoms continued to improve only for the BCI group. Targeted brain changes at the end of treatment predicted symptoms at 1 month for the BCI group only.

CONCLUSIONS

BCI is a promising treatment for CIPN and may have a longer lasting effect than placebo (nonspecific BCI), which is an important consideration for long-term symptom relief. Although scientifically interesting, the ability to separate real from placebo treatment may not be as important as understanding the placebo effects differently from effects of the intervention.

PLAIN LANGUAGE SUMMARY

Chemotherapy-induced nerve pain (neuropathy) can be disabling for cancer survivors; however, the way symptoms are felt depends on how the brain interprets the signals from nerves in the body. We determined that the perception of neuropathy can be changed by working directly with the brain. Survivors in our trial played 20 sessions of a type of video game that was designed to change the way the brain processed sensation and movement. In this, our second trial, we again observed significant improvement in symptoms that lasted after the treatment was complete.

摘要

背景

化疗引起的周围神经病(CIPN)包括持续存在的负面感觉,这仍是癌症幸存者的一个主要慢性问题。先前的研究表明,神经反馈(闭环脑机接口[BCI])在治疗 CIPN 方面优于候补对照组(WLC)。作者的先验假设是,BCI 优于安慰剂反馈(安慰剂对照[PLC])和 WLC,可缓解 CIPN,并且大脑活动的变化将预测症状报告。

方法

2014 年 11 月至 2018 年 11 月期间进行了随机分组至三个条件之一。不再接受治疗的乳腺癌幸存者在基线、20 次治疗结束时和 1 个月后进行评估。基于每位患者改变自身脑电图信号的能力,在 20 次治疗中给予听觉和视觉奖励。治疗结束时的疼痛质量评估量表(PQAS)是主要结局,还检查了脑电图信号和 1 个月的数据变化。

结果

BCI 和 PLC 组均报告症状明显减轻。与 WLC 组相比,BCI 组的效果大小差异大于 PLC 组(平均变化评分:BCI 与 WLC,-2.60 与 0.38;95%置信区间,-3.67,-1.46 [p=0.000;效应大小,1.07];PLC,-2.26;95%置信区间,-3.33,-1.19 [p=0.001 与 WLC;效应大小,0.9])。1 个月时,仅 BCI 组的症状继续改善。仅在 BCI 组中,治疗结束时的靶向大脑变化预测了 1 个月时的症状。

结论

BCI 是治疗 CIPN 的一种有前途的方法,其效果可能比安慰剂(非特异性 BCI)持续时间更长,这对长期缓解症状很重要。虽然在科学上很有趣,但区分真实与安慰剂治疗的能力可能不如理解安慰剂效应与干预措施的效果不同重要。

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