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Feasibility and Effects of Noninvasive Brain Stimulation on Pain Perception in People With Fibromyalgia

2026年6月11日 更新者：Pulkit Grover

Transcranial Electrical Stimulation for Noninvasive Study of Pain Circuits in Patients With Chronic Pain

The goal of this interventional study is to learn whether noninvasive brain stimulation (NIBS) will have an effect on pain perception in people with fibromyalgia. The main questions it aims to answer are:

Do repeated sessions of NIBS lead to a reduction in perceived pain? Do repeated sessions of NIBS lead to an improvement in quality of life?

Researchers will compare different brain targets to see if effects are different between them.

Participants will receive repeated daily sessions of NIBS over 4 weeks with application of pressure pain algometry, and complete various questionnaires.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Participants will randomly receive primary motor cortex (M1) or occipital lobe NIBS over 2 weeks, and after a wash-out period will receive NIBS of the other target over 2 weeks. Each session will also evaluate pressure pain algometry, various questionnaires to assess changes in fibromyalgia symptoms and quality of life (up to 5 hours per session)

NIBS administration will consist of 1000 electrical pulses of <1 ms duration each.

研究类型

介入性

注册 (估计的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Benedict J Alter, PhD
  • 电话号码：412-677-0575
  • 邮箱：alterbj@upmc.edu

学习地点

  • 美国
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15213
      • Pittsburgh、Pennsylvania、美国、15206
        • UPMC Pain Management
        • 接触：
          • Benedict J Alter, MD, PhD
          • 电话号码：412-677-0575
          • 邮箱：alterbj@upmc.edu
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Formal diagnosis of fibromyalgia made by a practicing physician
  • Pain resistant to common analgesics and medications for chronic pain
  • Existing pain for more than 3 months with an average of at least 4 on a 0 to 10 Numerical Rating Scale (NRS)
  • Females of child bearing potential must be at least one of the following totally abstinent from heterosexual intercourse since the last menses before start of study, or agree to concurrent use of at least two methods of birth control throughout study participation.

Exclusion Criteria:

  • If the subject is non-ambulatory.
  • If the subject is female of child-bearing potential, subject must not be pregnant.
  • Subject must not have a history of brain surgery or uncontrolled neurological conditions, such as seizure, fainting spells, transient ischemic attack.
  • Subject must not have lifetime history of severe, uncontrolled mood disorders (anxiety, depression, bipolar), psychotic disorders, other neural disorders, or heart disease.
  • Subject must not have any implanted electronic or metallic devices.
  • Subject must not have heart diseases, including known arrhythmia, or severe liver or severe gastrointestinal disease or chronic severe infectious disease (e.g. HIV/AIDS).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Primary Motor Cortex Stimulation, then Occipital Lobe Stimulation
The primary motor cortex will be targeted first, then the occipital lobe.
设备：Primary Motor Cortex Stimulation
Short (<1 ms), high amplitude (>10 mA) noninvasive electrical pulses delivered at 1 Hz on the scalp surface. This intervention will target the primary motor cortex (M1).
其他名称：
  • 经颅电刺激
设备：Occipital Lobe Stimulation
Short (<1 ms), high amplitude (>10 mA) noninvasive electrical pulses delivered at 1 Hz on the scalp surface. This intervention will target the occipital lobe.
其他名称：
  • 经颅电刺激
实验性的：Occipital Lobe Stimulation, then Primary Motor Cortex Stimulation
The occipital lobe will be targeted first, then the primary motor cortex.
设备：Primary Motor Cortex Stimulation
Short (<1 ms), high amplitude (>10 mA) noninvasive electrical pulses delivered at 1 Hz on the scalp surface. This intervention will target the primary motor cortex (M1).
其他名称：
  • 经颅电刺激
设备：Occipital Lobe Stimulation
Short (<1 ms), high amplitude (>10 mA) noninvasive electrical pulses delivered at 1 Hz on the scalp surface. This intervention will target the occipital lobe.
其他名称：
  • 经颅电刺激

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Feasibility of the transcranial electrical stimulation protocol
大体时间：From end of the last study session until up to 6 months after.
Feasibility of the protocol will be measured quantitatively using the Feasibility of Intervention Measure (FIM) score. Score ranges from 4 to 20, with higher scores indicating higher level of feasibility. It will also be assessed qualitatively via participant interviews.
From end of the last study session until up to 6 months after.
Tolerability of transcranial electrical stimulation protocol
大体时间：Every day from enrollment until up to 6 months after the last study session.
Determined qualitatively from study-related participant attrition rate (%) and adherence to protocol (%).
Every day from enrollment until up to 6 months after the last study session.
Acceptability of transcranial electrical stimulation protocol
大体时间：From end of the last study session until up to 6 months after.
Acceptability of the protocol will be measured quantitatively using the Acceptability of Intervention Measure (AIM) score. Score ranges from 4 to 20, with higher scores indicating higher level of acceptability. It will also be assessed qualitatively via participant interviews.
From end of the last study session until up to 6 months after.
Pressure pain threshold (PPT)
大体时间：At every study session from Session 1 until the last study session.
PPT (in lbf) will be measured using a digital algometer, which will be used to press down on the participants' thumb nails and legs to assess pain sensitization throughout the study.
At every study session from Session 1 until the last study session.

次要结果测量

结果测量
措施说明
大体时间
Revised Fibromyalgia Impact Questionnaire (FIQR)
大体时间：Weekly from enrollment until up to 6 months after the last study session.
FIQR will be used to assess the participant's experience with fibromyalgia (symptoms and impact on daily life). Score ranges from 0 to 100, with higher scores indicating greater severity of fibromyalgia symptoms and functional impairment.
Weekly from enrollment until up to 6 months after the last study session.
Brief Pain Inventory (BPI)
大体时间：Daily, from enrollment until up to 6 months after the last study session.
BPI will be used to assess the participant's pain severity and interference. Score ranges from 0 to 10, with higher scores indicating worse (more severe) pain or interference.
Daily, from enrollment until up to 6 months after the last study session.
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
大体时间：Weekly, from enrollment until up to 6 months after the last study session.
We will use the standardized survey score PROMIS-29 to assess physical and mental health in seven domains (e.g., physical function, anxiety, sleep disturbance etc.). Each question score ranges from one to five, corresponding to the intensity within the question's domain. Survey scores will be converted to a t-score metric and assessed.
Weekly, from enrollment until up to 6 months after the last study session.

其他结果措施

结果测量
措施说明
大体时间
Number of steps
大体时间：Every day from enrollment until up to 4 weeks after the last study session.
Assess change in number of steps taken daily using a wearable device.
Every day from enrollment until up to 4 weeks after the last study session.
Active zone minutes
大体时间：Every day from enrollment until up to 4 weeks after the last study session.
Assess change in number of minutes spent in active heart rate zone using a wearable device.
Every day from enrollment until up to 4 weeks after the last study session.
Sleep score
大体时间：Every day from enrollment until up to 4 weeks after the last study session.
Assess change in sleep quality using a wearable device.
Every day from enrollment until up to 4 weeks after the last study session.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Pulkit Grover

合作者

University of Pittsburgh Clinical and Translational Science Institute (CTSI)
Department of Anesthesiology & Perioperative Medicine, University of Pittsburgh

调查人员

  • 首席研究员：Benedict J Alter, MD, PhD、University of Pittsburgh
  • 首席研究员：Pulkit Grover, PhD、Carnegie Mellon University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2027年5月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年5月27日

首先提交符合 QC 标准的

2026年6月11日

首次发布 (实际的)

2026年6月12日

研究记录更新

最后更新发布 (实际的)

2026年6月12日

上次提交的符合 QC 标准的更新

2026年6月11日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • STUDY2025_00000279

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

IPD may be shared upon reasonable request to the study contacts.

IPD 共享时间框架

Data will become available after publication per journal and funding entity protocols.

IPD 共享访问标准

Data will be made available by reasonable request and/or per journal and funding entity protocols.

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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