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

1. mai 2026 oppdatert av: Oznur Buran Sevik, Hospital Donostia
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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Gipuzkoa
      • San Sebastián, Gipuzkoa, Spania, 20250
        • Hospital Universitario de Donostia

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Diagnosis of Fibromyalgia
  • Diagnosis of chronic fatigue syndrome

Exclusion Criteria:

  • Having both conditions at the same time

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: The patients with Fibromyalgia
The same treatment is applied (tDCS)
It is an neuromodulation technic
Aktiv komparator: The patients with chronic fatigue syndrome
The same treatment is applied ( tDCS)
It is a neuromodulation technic

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Visual Pain Scores (VAS)
Tidsramme: From enrollment to the end of treatment at 2 weeks
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)
Tidsramme: From enrollment to the end of treatment at 2 weeks
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studieleder: Adolfo Lopez de Munain, Doctor, University Hospital of Donostia
  • Studieleder: PEDRO MONTOYA, UNIVERSITY OF BALEARIC ISLANDS, MALLORCA

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

  • Moldofsky H. Fibromyalgia, sleep disorder and chronic fatigue syndrome. Ciba Found Symp. 1993;173:262-71; discussion 272-9. doi: 10.1002/9780470514382.ch15. PMID: 8491102.
  • 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. PMID: 8277801.
  • Lloyd, D. M., Wittkopf, P. G., Arendsen, L. J., & Jones, A. K. P. (2020). Is transcranial direct current stimulation (tDCS) effective for the treatment of pain in fibromyalgia? A systematic review and meta-analysis. The Journal of Pain, 21(11-12), 1085-1100. https://doi.org/10.1016/j.jpain.2020.01.003
  • 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. PMID: 21414620.
  • 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. PMID: 29889115
  • Hawker, G. A., et al. (2011).Measures of adult pain: Visual Analog Scale for Pain (VAS Pain). Arthritis Care & Research, 63(S11), S240-S252. https://doi.org/10.1002/acr.20543
  • 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. 7, Recommendations. Available from: https://www.ncbi.nlm.nih.gov/books/NBK284910/
  • Burckhardt CS1, Clark SR, Bennett RM. The fibromyalgia impact questionnaire: development and validation.J Rheumatol. 1991 May;18(5):728-33.
  • 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. PMID: 40939313.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2025

Primær fullføring (Faktiske)

1. mai 2025

Studiet fullført (Faktiske)

30. mai 2025

Datoer for studieregistrering

Først innsendt

21. april 2026

Først innsendt som oppfylte QC-kriteriene

1. mai 2026

Først lagt ut (Faktiske)

7. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

IPD may be shared upon reasonable request, subject to ethical approval and data use agreements.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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