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临床试验/NCT07573709
NCT07573709终止不适用

Functional and Affective Effects of a Brief tDCS Intervention in Fibromyalgia and Chronic Fatigue Syndrome

Hospital Donostia1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
不适用
状态
终止
发起方
入组人数
20
试验地点
1

研究概览

简要总结

Functional and Affective Effects of a brief tDCS Intervention in Fibromyalgia and Chronic Fatigue Syndrome Fibromyalgia (FM) and chronic fatigue syndrome (CFS) are characterized by persistent, multidimensional symptoms arising from complex brain-body interactions that impair functioning and quality of life. Noninvasive neuromodulation techniques such as transcranial direct current stimulation (tDCS) have been proposed as adjunctive approaches to support short-term functional changes within distributed neural systems, although evidence remains limited and heterogeneous. The objective is to examine immediate pre-post changes in multidimensional clinical outcomes following a standardized tDCS protocol in patients with FM and CFS, and to explore potential diagnosis-related response patterns.

详细描述

Abstract Background: Fibromyalgia (FM) and chronic fatigue syndrome (CFS) are characterized by persistent, multidimensional symptoms arising from complex brain-body interactions that impair functioning and quality of life. Noninvasive neuromodulation techniques such as transcranial direct current stimulation (tDCS) have been proposed as adjunctive approaches to support short-term functional changes within distributed neural systems, although evidence remains limited and heterogeneous. Objective: To examine immediate pre-post changes in multidimensional clinical outcomes following a standardized tDCS protocol in patients with FM and CFS, and to explore potential diagnosis-related response patterns. Methods: Fifteen patients (FM: n = 5; CFS: n = 10) received 10 sessions of tDCS (20 minutes per session) administered over two consecutive weeks (five sessions per week). Patient-reported outcomes were assessed at baseline and immediately after treatment completion. Measures included the Short Form-36 Health Survey (SF-36), Fibromyalgia Impact Questionnaire (FIQ), Hospital Anxiety and Depression Scale (HADS), Composite Autonomic Symptom Score (COMPASS), pain thermometer, Epworth Sleepiness Scale, Fatigue Severity Scale (FSS), and Fatigue Assessment Scale (FAS). Pre-post comparisons were conducted at the whole-sample level, followed by exploratory analyses stratified by diagnosis. Results: At baseline, patients with FM showed lower COMPASS, FSS, FAS, and HADS scores, and higher SF-36 scores, compared to patients with CFS, indicating a relatively less severe clinical profile. Across the sample, pre-post comparisons indicated improvements in FIQ and HADS scores. Exploratory group-specific analyses suggested that FM patients exhibited reductions in depressive symptoms, whereas CFS patients showed improvements in quality of life (SF-36) and functional impact (FIQ). No significant changes were observed in subjective pain intensity or fatigue severity (FSS). Conclusions: These findings suggest partially distinct clinical profiles and differential responsiveness to tDCS across FM and CFS, within the context of baseline differences between groups. Improvements appeared domain-specific, with affective symptoms responding in FM and functional outcomes in CFS, while core symptoms such as pain and fatigue remained unchanged over the intervention period. This pattern provides preliminary support for the idea that short-term neuromodulation may preferentially influence higher-order regulatory processes rather than core symptom generators, underscoring the need for tailored, multidimensional treatment approaches. Nevertheless, given the small sample size, absence of a control condition, and exploratory nature of subgroup analyses, these results should be interpreted with caution. Further controlled

studies are needed to clarify the reliability, specificity, and clinical relevance of these effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Fibromyalgia
  • Diagnosis of chronic fatigue syndrome

排除标准

  • Having both conditions at the same time

研究者

发起方
Hospital Donostia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Oznur Buran Sevik

Physical Medicine and Rehabilitation Specialist Doctor

Hospital Donostia

研究点 (1)

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