NCT07573709

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

April 21, 2026

Last Update Submit

May 1, 2026

Conditions

Fibromyalgia (FM)Chronic Fatigue Syndrome (CFS)

Keywords

tdcspainfatigue

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

The patients with Fibromyalgia

ACTIVE COMPARATOR

The same treatment is applied (tDCS)

Device: Transcraneal Direct Current Electric Stimulation (tDCS)

The patients with chronic fatigue syndrome

ACTIVE COMPARATOR

The same treatment is applied ( tDCS)

Device: Transcranial Direct Current Electric Stimulation (tDCS)

Interventions

Transcraneal Direct Current Electric Stimulation (tDCS)DEVICE

It is an neuromodulation technic

The patients with Fibromyalgia
Transcranial Direct Current Electric Stimulation (tDCS)DEVICE

It is a neuromodulation technic

The patients with chronic fatigue syndrome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Fibromyalgia
  • Diagnosis of chronic fatigue syndrome

You may not qualify if:

  • Having both conditions at the same time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Donostia

San Sebastián, Gipuzkoa, 20250, Spain

Location

Related Publications (9)

  • 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.

    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. PMID: 8277801.

    BACKGROUND

  • 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

    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. PMID: 21414620.

    BACKGROUND

  • 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

    RESULT

  • 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

    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. 7, Recommendations. Available from: https://www.ncbi.nlm.nih.gov/books/NBK284910/

    RESULT

  • Burckhardt CS1, Clark SR, Bennett RM. The fibromyalgia impact questionnaire: development and validation.J Rheumatol. 1991 May;18(5):728-33.

    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. PMID: 40939313.

    RESULT

MeSH Terms

Conditions

FibromyalgiaFatigue Syndrome, ChronicPainFatigue

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesEncephalomyelitisNeuroinflammatory DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Adolfo Lopez de Munain, Doctor

    University Hospital of Donostia

    STUDY DIRECTOR

  • PEDRO MONTOYA

    UNIVERSITY OF BALEARIC ISLANDS, MALLORCA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Medicine and Rehabilitation Specialist Doctor

Study Record Dates

First Submitted

April 21, 2026

First Posted

May 7, 2026

Study Start

January 1, 2025

Primary Completion

May 1, 2025

Study Completion

May 30, 2025

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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

Locations

ES(1)