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Effects of Non-invasive Brain Stimulation on Pain Avoidance Behavior in Chronic Pain Patients

2026年8月26日 更新者：Raghavan Gopalakrishnan、The Cleveland Clinic

Alpha tACS and Pain Avoidance Behavior in Chronic Pain Patients

Pain avoidance helps with survival. However, chronic pain patients often avoid valued life activities fearing onset or exacerbation of pain. Hence, pain avoidance no longer protects, but reduces quality of life. The goal of this clinical trial is to learn if non-invasive brain stimulation technique called transcranial alternating current stimulation (tACS) impact pain avoidance behavior in chronic pain patients. tACS is a way to gently stimulate the brain using a small, portable device. It sends an extremely weak, continuous alternating current through the scalp. Participants will either get real tACS or a fake (sham) version. Real tACS will stimulate the brain in the alpha frequency (8-12 Hz) which has been found to influence pain avoidance behavior, whereas sham tACS will stimulate the brain in a different frequency that is not known to influence avoidance behavior. The main questions it aims to answer are:

Does tACS alter the way chronic pain patients confront pain in terms of avoidance behavior? How does tACS impact brain signals related to pain avoidance behavior?

Participants will:

  1. fill out self-administered questionnaires asking about their medication use, personality and temperament, mood, including anxiety and depression, current pain level, and any disability you have due to your pain.
  2. perform of a pain avoidance task before, during and after 'real' tACS or 'sham' tACS. They may also be asked to stay quiet before, during and after tACS. During this period, we will scan the brain using a neuroimaging device called Magnetoencephalography (MEG). Additionally, Electroencephalography (EEG) brain signals will also be collected using electrodes affixed to the scalp. We may also measure Skin conductance response (SCR) and electrocardiography (EKG) using electrodes affixed to the skin.
  3. also get a T1 MRI if they do not have an implanted SCS, DRG, intrathecal pump, or other similar device that are not MRI compatible.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

30

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

  • 姓名：Raghavan Gopalakrishnan
  • 电话号码：2164459322
  • 邮箱：gopalar@ccf.org

学习地点

  • 美国
    • Ohio
      • Cleveland、Ohio、美国、44195
        • 招聘中
        • Cleveland Clinic
        • 接触：
          • Raghavan Gopalakrishnan
          • 电话号码：800-223-2273
          • 邮箱：gopalar@ccf.org

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:

  • Age 18 years or older
  • Diagnosed with Complex Regional Pain Syndrome (CRPS) Type I or II, based on Budapest criteria
  • 6 months or more of medically refractory severe pain
  • Average daily pain for past 30 days >= 5 on 0-10 scale
  • Presence of allodynia and/or hyperalgesia
  • Lower extremity CRPS: bilateral or unilateral pain
  • Not concurrently treated with neurostimulation therapies such as spinal cord stimulators (SCS)
  • Absence of co-occurring severe psychiatric disorders (PHQ-9<19 and/or GAD-7<14)

Exclusion Criteria:

  • Age under 18 years, pregnant women of any age
  • Any co-occurring pain diagnosis that might confound with allodynia/hyperalgesia resulting from CRPS reflecting a malfunction in sensory processing within the CNS.
  • Less than six months of medically refractory pain
  • Average daily pain for past 30 days <5 on 0-10 scale
  • Absence of allodynia and/or hyperalgesia
  • Concurrent neurostimulation therapies such as SCS
  • Severe disorders or conditions (e.g., cardiovascular, liver issues), terminal illness
  • PHQ-9>19 and/or GAD-7>14 (severe depression/anxiety)

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：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：alpha frequency tACS
设备：transcranial alternating current stimulation (tACS)
Real tACS will stimulate the brain in the individual alpha frequency (8-12 Hz) measured from baseline MEG
设备：transcranial alternating current stimulation (tACS)
active control tACS will stimulate the brain at 40Hz
有源比较器：gamma frequency tACS
设备：transcranial alternating current stimulation (tACS)
Real tACS will stimulate the brain in the individual alpha frequency (8-12 Hz) measured from baseline MEG
设备：transcranial alternating current stimulation (tACS)
active control tACS will stimulate the brain at 40Hz

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
magnitude of alpha frequency band power
大体时间：Periprocedural
measured using MEG/EEG from resting-state and during the performance of pain avoidance task. The MEG/EEG neural signals will be transformed to frequency domain to measure the magnitude of power in the alpha band.
Periprocedural

次要结果测量

结果测量
措施说明
大体时间
standard deviation in R-R length
大体时间：Periprocedural
standard deviation in R-R length (SDNN), a measure of heart rate variability from RR interval tachogram derived from EKG.
Periprocedural
number of spontaneous skin conductance fluctuations
大体时间：Periprocedural
number of spontaneous skin conductance fluctuations will be measured from galvanic skin conductance response time-series data.
Periprocedural

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

The Cleveland Clinic

合作者

National Center for Complementary and Integrative Health (NCCIH)

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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10月1日

初级完成 (估计的)

2028年8月31日

研究完成 (估计的)

2028年12月1日

研究注册日期

首次提交

2026年8月18日

首先提交符合 QC 标准的

2026年8月26日

首次发布 (实际的)

2026年8月28日

研究记录更新

最后更新发布 (实际的)

2026年8月28日

上次提交的符合 QC 标准的更新

2026年8月26日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 26-220
  • R21AT013595 (美国 NIH 拨款/合同)

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

De-identified individual participant data underlying the results reported in publications, along with relevant study documentation and analytic code, may be shared with qualified researchers upon reasonable request to the study investigators. Data will be available following publication of the primary study results, subject to applicable institutional policies, informed consent provisions, and execution of an appropriate data use agreement.

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

是的

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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