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| ID | Type | Description | Link |
|---|---|---|---|
| European Regional Development | Other Identifier | grant #PID2022-140561NB-I00. |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The patients with Fibromyalgia | Active Comparator | The same treatment is applied (tDCS) |
|
| The patients with chronic fatigue syndrome | Active Comparator | The same treatment is applied ( tDCS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcraneal Direct Current Electric Stimulation (tDCS) | Device | It is an neuromodulation technic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Pain Scores (VAS) | It is measured before and inmediately after the treatment ( tDCS) is applied. (0-10) Higher scores mean more pain. | From enrollment to the end of treatment at 2 weeks |
| Fibromyalgia Impact Questionnaire (FIQ) | It measures the impact of fibromyalgia (Scores: 0-100) The FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person. | From enrollment to the end of treatment at 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adolfo Lopez de Munain, Doctor | University Hospital of Donostia | Study Director |
| PEDRO MONTOYA | UNIVERSITY OF BALEARIC ISLANDS, MALLORCA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Donostia | San Sebastián | Gipuzkoa | 20250 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8491102 | Background | Moldofsky H. Fibromyalgia, sleep disorder and chronic fatigue syndrome. Ciba Found Symp. 1993;173:262-71; discussion 272-9. doi: 10.1002/9780470514382.ch15. | |
| 8277801 | Background | McHorney CA, Ware JE Jr, Lu JF, Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care. 1994 Jan;32(1):40-66. doi: 10.1097/00005650-199401000-00004. |
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IPD may be shared upon reasonable request, subject to ethical approval and data use agreements.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 30, 2026 |
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A pilot study in which is investigated the clinical outcomes of transcraneal direct current stimulation in two gruoups: Fibromyalgia and Chronic Fatigue Syndrome group. All participants received tdcs. Functional outcomes including some scales such as fibromialgia impact questionnaire, SF-36, fatigue severity scale, Visual analog pain scale. The scale scores are analysed pre-post treatment and than is realized the comparison in both of groups.
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| Transcranial Direct Current Electric Stimulation (tDCS) | Device | It is a neuromodulation technic |
|
| 31982685 | Background | Lloyd DM, Wittkopf PG, Arendsen LJ, Jones AKP. Is Transcranial Direct Current Stimulation (tDCS) Effective for the Treatment of Pain in Fibromyalgia? A Systematic Review and Meta-Analysis. J Pain. 2020 Nov-Dec;21(11-12):1085-1100. doi: 10.1016/j.jpain.2020.01.003. Epub 2020 Jan 23. |
| 21414620 | Background | Lerdal A, Kottorp A. Psychometric properties of the Fatigue Severity Scale-Rasch analyses of individual responses in a Norwegian stroke cohort. Int J Nurs Stud. 2011 Oct;48(10):1258-65. doi: 10.1016/j.ijnurstu.2011.02.019. Epub 2011 Mar 16. |
| 29889115 | Result | Hendriks C, Drent M, Elfferich M, De Vries J. The Fatigue Assessment Scale: quality and availability in sarcoidosis and other diseases. Curr Opin Pulm Med. 2018 Sep;24(5):495-503. doi: 10.1097/MCP.0000000000000496. |
| 22588748 | Result | Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available. |
| 25695122 | Result | Committee on the Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome; Board on the Health of Select Populations; Institute of Medicine. Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness. Washington (DC): National Academies Press (US); 2015 Feb 10. Available from http://www.ncbi.nlm.nih.gov/books/NBK274235/ |
| 1865419 | Result | Burckhardt CS, Clark SR, Bennett RM. The fibromyalgia impact questionnaire: development and validation. J Rheumatol. 1991 May;18(5):728-33. |
| 40939313 | Result | Bartholomew EJ, Medvedev ON, Petrie KJ, Chalder T. Rasch analysis of the hospital anxiety and depression scale in patients with chronic fatigue syndrome. J Psychosom Res. 2025 Oct;197:112370. doi: 10.1016/j.jpsychores.2025.112370. Epub 2025 Sep 3. |
| May 1, 2026 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D015673 | Fatigue Syndrome, Chronic |
| D010146 | Pain |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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