此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

神经反馈治疗糖尿病患者的神经性疼痛

2026年9月10日 更新者：Francois Pouwer、University of Southern Denmark
我们将开展一项高质量、盲法、随机对照试验 (RCT)，严格测试基于脑电图的 NF 对糖尿病相关神经性疼痛患者的有效性：1) 降低疼痛强度和疼痛影响，2) 每日改善功能和生活质量。

研究概览

地位

招聘中

条件

干预/治疗

详细说明

20%-40% 的糖尿病患者会出现糖尿病性多发性神经病 (DPN)，这通常表现为一种痛苦的并发症，严重降低生活质量。 目前针对神经性疼痛的标准药物治疗通常无效并且具有相当大的副作用。 因此，迫切需要更好的治疗选择。 大脑解释来自外周信号的方式可以通过学习某些技术来改变，这可以使患者能够改变与疼痛 DPN 相关的信号，从而体验到疼痛减轻。 神经反馈（NF）是一种很有前途的神经调节疗法，个人可以接收有关大脑神经生理信号的实时反馈，从而增强对大脑活动的意志控制，减少疼痛体验。 神经反馈使用连接到计算机屏幕的头皮脑电图电极，为个人提供实时反馈。 神经纤维化可以通过教导患者自行调节相关活动模式来缓解症状。 每当神经活动向期望的方向变化时就奖励人，就可以调节该活动。 尚未在患有疼痛 DPN 的患者中进行随机对照试验研究 NF。 这项丹麦-巴西拟议项目是第一个三盲随机对照试验，严格测试 EEG-NF 干预对糖尿病神经病理性疼痛 (NP) 的影响。 治疗将在两个随机组中进行 10 次以上：真实 EEG-NF 组和假 EEG-NF 组（安慰剂）。 巴西参与者还将接受（功能）磁共振成像 (fMRI) 扫描，以研究 NF 治疗如何瞄准和改变神经机制。 如果发现有效，低成本的 EEG-NF 可以为糖尿病和疼痛性神经病患者大规模提供和实施，并且低收入和中等收入国家也可以使用。

研究类型

介入性

注册 (估计的)

60

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

学习地点

  • 丹麦
      • Odense、丹麦、5230
        • 招聘中
        • University of Southern Denmark
        • 接触：
        • 首席研究员：
          • Francois Pouwer, Professor

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

纳入标准：

年龄≥18岁且≤82岁

  • 诊断患有 1) 1 型糖尿病（至少 5 年）或 2) 2 型糖尿病
  • 多伦多共识标准将用于 DPN 的病例定义，其中患者必须至少患有可能的 DPN (31)。 DPN 诊断通过异常 DPN 检查来确诊。 疼痛性 DPN 将使用神经性疼痛分级系统 (50) 进行定义，并且符合 IASP 对神经性疼痛的定义，即“由体感系统病变或疾病引起的疼痛”（多伦多共识标准）。
  • TCNS 分数 > 5
  • 符合资格的 DPN 疼痛患者的疼痛强度必须达到 11 点数字评定量表（NRS，0-10）至少 4 级，持续至少 3 个月，至少每半天一次，且除以下原因引起的疼痛外，无严重疼痛：神经病变（疼痛强度将基于患者在当前疼痛治疗（如果有）时经历的疼痛）。
  • 入组前稳定止痛药 > 1 个月。 排除标准

排除标准：

  • 伴随神经系统疾病（神经退行性疾病、偏头痛、癫痫、中风、肿瘤）或有临床意义的精神疾病
  • 糖尿病以外的其他原因引起的神经病或神经性疼痛（维生素 B12 缺乏、既往接受过神经毒性化疗、长期酗酒、椎管狭窄等）
  • 治疗期间改变当前疼痛治疗方法（允许使用扑热息痛作为救援药物）
  • 之前或当前过量饮酒（女性和男性每周分别>14或>21单位）或非法药物滥用
  • 尿液 hCG 检测结果呈阳性表明怀孕
  • 吗啡使用量 >20 毫克/天
  • 失明或视力严重受损
  • 研究者发现患者不适合研究（例如 由于使用酒精或药物、精神障碍、不愿意或语言障碍妨碍充分理解或合作或存在研究者认为可能导致对研究方案的遵守不佳的任何情况）。

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：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：真实脑电图神经反馈
NF干预组将收到基于真实实时脑电图活动的反馈
行为的：EEG-neurofeedback
Traditional neurofeedback uses one or two electrodes to modulate activity within a specific frequency band. Standardized Weighted Low Resolution Electromagnetic Tomography (swLORETA) analyzes the 3D distribution of intracortical brain electrical activity based on surface EEG recordings, enabling real-time brainwave imaging with a spatial resolution under one cubic centimeter. This divides the brain into over 12,000 voxels, offering localization similar to fMRI while maintaining EEG's faster temporal resolution. Source-localized NF can target specific, deeper brain regions, multiple Brodmann areas simultaneously, and provide feedback on connectivity between neural sources, enabling the training of specific neural networks. swLORETA metrics are compared to a normative database of neurotypical brains to produce z-scores for each area and metric. NeuroGuide is used within the FDA 510(k)-cleared NeuroGuide Analysis System (K041263); clearance does not imply treatment validation.
假比较器：假脑电图神经反馈
假手术组将接收另一名参与者的脑电图训练协议作为预先录制的信号。 反馈信号将包含每分钟 15-25 个奖励。 同时，假手术组的阈值保持固定，确保一致的 70% 正反馈率。
行为的：EEG-neurofeedback
Traditional neurofeedback uses one or two electrodes to modulate activity within a specific frequency band. Standardized Weighted Low Resolution Electromagnetic Tomography (swLORETA) analyzes the 3D distribution of intracortical brain electrical activity based on surface EEG recordings, enabling real-time brainwave imaging with a spatial resolution under one cubic centimeter. This divides the brain into over 12,000 voxels, offering localization similar to fMRI while maintaining EEG's faster temporal resolution. Source-localized NF can target specific, deeper brain regions, multiple Brodmann areas simultaneously, and provide feedback on connectivity between neural sources, enabling the training of specific neural networks. swLORETA metrics are compared to a normative database of neurotypical brains to produce z-scores for each area and metric. NeuroGuide is used within the FDA 510(k)-cleared NeuroGuide Analysis System (K041263); clearance does not imply treatment validation.

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
Pain intensity
大体时间：Seven consecutive days before baseline EEG assessment (T0; days -7 to -1) and seven consecutive days following the 10th and final neurofeedback session (T1; days +1 to +7).
The primary aim is to evaluate whether real EEG-NF compared with sham EEG-NF, leads to a greater reduction in self-reported pain intensity (NRS from 0-10) from T0 (baseline) to T1 (after 10th and final session), assessed using mean 7-day pain intensity derived from an electronic pain diary.
Seven consecutive days before baseline EEG assessment (T0; days -7 to -1) and seven consecutive days following the 10th and final neurofeedback session (T1; days +1 to +7).

次要结果测量

结果测量
措施说明
大体时间
Neuropathic pain symptoms
大体时间：Inclusion visit (pre-intervention), post-treatment assessment (after the 10th and final neurofeedback session), and 4 months after completion of the intervention.
Differences in neuropathic pain symptoms will be assessed using the Neuropathic pain scale (NPS). Changes from baseline will be evaluated following the intervention and at 4-month follow-up, and differences between the real EEG-NF and sham EEG-NF groups will be examined.
Inclusion visit (pre-intervention), post-treatment assessment (after the 10th and final neurofeedback session), and 4 months after completion of the intervention.
Pain interference
大体时间：Inclusion visit (pre-intervention), post-treatment assessment (after the 10th and final neurofeedback session), and 4 months after completion of the intervention.
Pain interference will be assessed using the Brief Pain Inventory (BPI) interference scale. Changes from baseline will be evaluated following the intervention and at 4-month follow-up, and differences between the real EEG-NF and sham EEG-NF groups will be examined.
Inclusion visit (pre-intervention), post-treatment assessment (after the 10th and final neurofeedback session), and 4 months after completion of the intervention.
Sleep
大体时间：Inclusion visit (pre-intervention), post-treatment assessment (after the 10th and final neurofeedback session), and 4 months after completion of the intervention.
Sleep disturbance will be assessed using the PROMIS sleep measure. Changes over time and between-group differences will be examined.
Inclusion visit (pre-intervention), post-treatment assessment (after the 10th and final neurofeedback session), and 4 months after completion of the intervention.
Pain network abnormality burden
大体时间：Baseline EEG assessment and post-treatment EEG assessment after completion of the 10th and final neurofeedback session.
Neurophysiological outcomes will be assessed using normative z-scores within the predefined pain-related network. A composite pain-network abnormality burden will be derived across EEG features, with domain-specific measures for current source density (CSD), instantaneous coherence, and lagged coherence also examined. Changes from pre- to post-intervention will be compared between the real EEG-NF and sham EEG-NF groups.
Baseline EEG assessment and post-treatment EEG assessment after completion of the 10th and final neurofeedback session.
Global impression of change
大体时间：After completion of the 10th and final neurofeedback session (T1) and at 4-month follow-up (T2).
Participants' overall perceived change in their condition will be assessed using the Patient Global Impression of Change (PGIC). Ratings following treatment and at follow-up will be summarized and compared between the real EEG-NF and sham EEG-NF groups as a supportive secondary outcome.
After completion of the 10th and final neurofeedback session (T1) and at 4-month follow-up (T2).
Pain catastrophizing
大体时间：Inclusion visit (pre-intervention), post-treatment assessment (after the 10th and final neurofeedback session), and 4 months after completion of the intervention.
Pain catastrophizing and coping will be assessed using the Pain Catastrophizing Scale (PCS). Changes from baseline will be evaluated following the intervention and at 4-month follow-up, and differences between the real EEG-NF and sham EEG-NF groups will be examined.
Inclusion visit (pre-intervention), post-treatment assessment (after the 10th and final neurofeedback session), and 4 months after completion of the intervention.
Quality of Life
大体时间：Inclusion visit (pre-intervention), post-treatment assessment (after the 10th and final neurofeedback session), and 4 months after completion of the intervention.
Quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF). Changes from baseline will be evaluated following the intervention and at 4-month follow-up, and differences between the real EEG-NF and sham EEG-NF groups will be examined.
Inclusion visit (pre-intervention), post-treatment assessment (after the 10th and final neurofeedback session), and 4 months after completion of the intervention.
Daily sleep interference
大体时间：Seven consecutive days before baseline (T0; days -7 to -1) and seven consecutive days following the 10th and final neurofeedback session (T1; days +1 to +7).
Sleep interference will be assessed using daily self-reported ratings collected as part of the electronic diary. Mean ratings will be derived for the predefined baseline and post-intervention assessment periods.
Seven consecutive days before baseline (T0; days -7 to -1) and seven consecutive days following the 10th and final neurofeedback session (T1; days +1 to +7).
Brief Pain Inventory (BPI) pain severity score
大体时间：Inclusion visit (pre-intervention), post-treatment assessment (after the 10th and final neurofeedback session), and 4 months after completion of the intervention.
Pain severity will be assessed using the pain severity items of the Brief Pain Inventory (BPI). Changes over time and differences between the real EEG-NF and sham EEG-NF groups will be examined, with the 4-month follow-up used to assess durability of treatment effects.
Inclusion visit (pre-intervention), post-treatment assessment (after the 10th and final neurofeedback session), and 4 months after completion of the intervention.
Mood
大体时间：Inclusion visit (pre-intervention), post-treatment assessment (after the 10th and final neurofeedback session), and 4 months after completion of the intervention.
Mood will be assessed using the PROMIS mood measure. Changes over time and between-group differences will be examined.
Inclusion visit (pre-intervention), post-treatment assessment (after the 10th and final neurofeedback session), and 4 months after completion of the intervention.
Fatigue
大体时间：Inclusion visit (pre-intervention), post-treatment assessment (after the 10th and final neurofeedback session), and 4 months after completion of the intervention.
Fatigue will be assessed using the PROMIS fatigue measure. Changes over time and between-group differences will be examined.
Inclusion visit (pre-intervention), post-treatment assessment (after the 10th and final neurofeedback session), and 4 months after completion of the intervention.

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

University of Southern Denmark

合作者

Aarhus University Hospital
Region of Southern Denmark
European Foundation for the Study of Diabetes
Steno Diabetes Center Odense
Vissing fonden

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 (实际的)

2024年9月1日

初级完成 (估计的)

2027年2月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2024年8月29日

首先提交符合 QC 标准的

2024年9月16日

首次发布 (实际的)

2024年9月19日

研究记录更新

最后更新发布 (实际的)

2026年9月15日

上次提交的符合 QC 标准的更新

2026年9月10日

最后验证

2026年9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

  • 11.719

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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

在美国制造并从美国出口的产品

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.

订阅