Objective:

Limited research has directly investigated whether and how placebo effects can be harnessed for the treatment of functional neurological disorder (FND), despite a long-standing and controversial history of interest in this area.

Methods:

A small exploratory study was conducted with adults with a cognitive subtype of FND recruited from a single cognitive neurology center in the United States. Participants were given the expectation of receiving cranial stimulation that could benefit their memory symptoms; however, the intervention was sham transcranial magnetic stimulation (placebo). Outcomes included measures of short-term memory testing, subjective memory rating, and state anxiety before and after stimulation. After the study, the true objective and rationale for investigating placebo effects were explained in a scripted debriefing session. Acceptability of the study design and qualitative feedback were collected. Institutional ethics approval and signed consent were obtained.

Results:

Three patients (female, N=2; male, N=1; average age=57 years) were recruited. Outcome data were analyzed descriptively at the patient level. Trends of improvement in subjective memory rating, but not objective cognitive test scores, and decreases in state anxiety were observed. After the debriefing session, all patients found the study design to be acceptable (ratings of 70%, 90%, and 100%), and two of the three patients believed that withholding mechanistic information about the intervention was needed to leverage placebo effects as treatment.

Conclusions:

In the first study to prospectively investigate the feasibility of harnessing placebo effects for the treatment of FND, promising preliminary findings were obtained, and methods and resources for use in larger future studies are offered.

中文翻译：

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利用安慰剂效应治疗功能性认知障碍：可行性试点研究

客观的：

尽管对这一领域的兴趣由来已久且存在争议，但直接调查是否以及如何利用安慰剂效应来治疗功能性神经障碍 (FND) 的研究有限。

方法：

一项小型探索性研究从美国的一个认知神经病学中心招募了患有 FND 认知亚型的成年人。参与者期望接受颅部刺激，这可能有益于他们的记忆症状；然而，干预是假经颅磁刺激（安慰剂）。结果包括短期记忆测试、主观记忆评级以及刺激前后的状态焦虑的测量。研究结束后，在有脚本的汇报会议中解释了调查安慰剂效应的真正目标和理由。收集研究设计的可接受性和定性反馈。获得机构道德批准并签署同意书。

结果：

招募了三名患者（女性，N=2；男性，N=1；平均年龄=57岁）。在患者层面对结果数据进行描述性分析。观察到主观记忆评分的改善趋势，但客观认知测试分数没有改善，以及状态焦虑的减少。汇报会结束后，所有患者都认为研究设计是可以接受的（评分为 70%、90% 和 100%），三名患者中的两名认为需要隐瞒有关干预的机制信息，以利用安慰剂效应作为治疗。

结论：

在第一项前瞻性研究利用安慰剂效应治疗 FND 的可行性的研究中，获得了有希望的初步结果，并提供了用于未来更大规模研究的方法和资源。