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Tools for the Differential Diagnosis of Fibromyalgia Based on Cognitive Tasks

Development of Complementary Tools for the Differential Diagnosis of Fibromyalgia Based on Cognitive Task Performance

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05910372
Enrollment
30
Registered
2023-06-18
Start date
2023-04-25
Completion date
2023-12-01
Last updated
2025-03-30

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

Conditions

Fibromyalgia

Keywords

Contralateral Delay Activity, Electroencephalography, Cognitive task, Biomarker

Brief summary

The goal of this observational study is to test for behavioural and neurophysiological biomarkers in fibromyalgia patients. The main questions it aims to answer are: * Is there a measurable decline in working memory? * Could these measures help in fibromyalgia differential diagnosis? Participants will: * perform Color Comparison tasks * perform n-back tasks

Detailed description

Fibromyalgia is a disease characterized by the presence of generalized musculoskeletal pain, accompanied by non-specific symptoms such as depression, sleep disturbances, anxiety, cognitive disabilities, among others. While widespread musculoskeletal pain is the predominant symptom in patients with fibromyalgia, cognitive impairments have also been widely reported, including decreased ability to concentrate, decreased short-term memory, and inability to multitask, which differentiate fibromyalgia patients from those with other chronic pain syndromes. Specifically, quantitative evidence has been found of impairment in executive functions in this group of patients, particularly in the domains of inhibitory control and working memory. In the present study, participants (both healthy individuals and those diagnosed with fibromyalgia) will perform two cognitive tasks designed to assess the capacity and retrieval of information from working memory. The first task is the Color Comparison task, in which colored squares will appear on a computer screen for a short period of time. After a blank delay, a new set of squares will appear, and a decision has to be made about whether or not the squares are the same as the ones shown first. The task will be divided into 10 blocks of 30 trials each, with 10 trials comparing 2 colored squares, 10 trials comparing 4 colored squares, and 10 trials comparing 6 colored squares. A resting period will be given between each block. The behavioral results of this task will include reaction times and hit rates. At the same time, electroencephalographic data will be recorded to evaluate the Contralateral Delay Activity (CDA). The amplitude of this waveform is linked to the number of items allocated in working memory. The second task that will be carried out by the participants is the n-back task. A sequence of letters will be presented, and participants will be asked to indicate whether the current stimulus matches the one presented two stimuli earlier. Sixty-two stimuli will be presented per block, and 5 blocks will be carried out. The results will be analyzed in terms of behavioral analysis and Event-Related Potentials (ERPs) analysis.

Interventions

OTHERColor Comparison Task

Participants are presented with a series of colored squares and are instructed to compare the colors of two sequentially presented stimuli.

Participants are presented with a sequence of letters and they must indicate whether the current stimulus matches the one presented 2 steps back in the sequence.

Sponsors

Center for Nuclear and Molecular Medicine Entre Ríos
CollaboratorUNKNOWN
National Council of Scientific and Technical Research, Argentina
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

Fibromyalgia patients: * Primary diagnosis of fibromyalgia according to the criteria used by the healthcare professional in charge of the patient. * Other comorbidities are accepted as long as the pain caused by them is less severe than the pain caused by fibromyalgia. * Willingness and ability to fully understand the content and scope of the experiment and to comply with the experiment instructions. * Normal or corrected-to-normal vision. Healthy controls: * No history of neurological diseases, chronic pain or musculoskeletal disorders. * Willingness and ability to fully understand the content and scope of the experiment and to comply with the experiment instructions. * Normal or corrected-to-normal vision.

Exclusion criteria

Fibromyalgia patients: * Pregnancy * History of addictive behavior, defined as alcohol, cannabis, opioids or other drugs abuse. * Presence of fever, tuberculosis, malignant tumors, infectious processes, acute inflammatory processes. * Lack of cooperation Healthy controls: * Pregnancy * History of chronic pain or musculoskeletal or articular disorders * History of addictive behavior, defined as alcohol, cannabis, opioids or other drugs abuse. * Presence of fever, tuberculosis, malignant tumors, infectious processes, acute inflammatory processes. * Lack of cooperation

Design outcomes

Primary

MeasureTime frameDescription
Percentage of correct answers in the Color Comparison taskImmediately after the interventionPercentage of correct answers over total number of trial in the Color Comparison Task

Secondary

MeasureTime frameDescription
Symptoms Impact Questionnaire (SIQ)10 minutes before the interventionInstrument to assess healthy control's status regarding relevant clinical symptoms experienced in the last week.
Hospital Anxiety and Depression Scale (HADS)10 minutes before the interventionWidely used instrument to evaluate anxiety and depression
Brief Pain Inventory-Short Form (BPI-SF)10 minutes before the interventionIt is an instrument to assess the severity of pain and its impact on functioning.
Fibromyalgia Impact Questionnaire-Revised version (FIQR)10 minutes before the interventionInstrument for the assessment and evaluation of fibromyalgia patient's status
Event-related potentials amplitudeImmediately after the interventionAmplitude, in microvolts, of event-related brain potentials
Event-related potentials latencyImmediately after the interventionLatency, in milliseconds, of event-related brain potentials
Power in EEG bandsImmediately after the interventionAnalysis of EEG spectrum bands

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026