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

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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07573709
Acronym
FibFatDCS
Enrollment
20
Registered
2026-05-07
Start date
2025-01-01
Completion date
2025-05-30
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Fatigue Syndrome (CFS), Fibromyalgia (FM)

Keywords

tdcs, pain, fatigue

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.

Detailed description

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.

Interventions

DEVICETranscraneal Direct Current Electric Stimulation (tDCS)

It is an neuromodulation technic

DEVICETranscranial Direct Current Electric Stimulation (tDCS)

It is a neuromodulation technic

Sponsors

Hospital Donostia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of Fibromyalgia * Diagnosis of chronic fatigue syndrome

Exclusion criteria

* Having both conditions at the same time

Design outcomes

Primary

MeasureTime frameDescription
Visual Pain Scores (VAS)From enrollment to the end of treatment at 2 weeksIt is measured before and inmediately after the treatment ( tDCS) is applied. (0-10) Higher scores mean more pain.
Fibromyalgia Impact Questionnaire (FIQ)From enrollment to the end of treatment at 2 weeksIt 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.

Countries

Spain

Contacts

STUDY_DIRECTORAdolfo Lopez de Munain, Doctor

University Hospital of Donostia

STUDY_DIRECTORPEDRO MONTOYA

UNIVERSITY OF BALEARIC ISLANDS, MALLORCA

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026