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Completed

NCT Number: NCT05910372

Tools for the Differential Diagnosis of Fibromyalgia Based on Cognitive Tasks

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Nuclear and Molecular Medicine Entre Ríos (CEMENER)

Oro Verde, Entre Ríos Province, 3100, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Color Comparison Task

Other

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

N-back Task

Other

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.

Primary outcomes

  1. Percentage of correct answers in the Color Comparison task

    Time frame: Immediately after the intervention

    Percentage of correct answers over total number of trial in the Color Comparison Task

Secondary outcomes

  1. Fibromyalgia Impact Questionnaire-Revised version (FIQR)

    Time frame: 10 minutes before the intervention

    Instrument for the assessment and evaluation of fibromyalgia patient's status

  2. Symptoms Impact Questionnaire (SIQ)

    Time frame: 10 minutes before the intervention

    Instrument to assess healthy control's status regarding relevant clinical symptoms experienced in the last week.

  3. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 10 minutes before the intervention

    Widely used instrument to evaluate anxiety and depression

  4. Brief Pain Inventory-Short Form (BPI-SF)

    Time frame: 10 minutes before the intervention

    It is an instrument to assess the severity of pain and its impact on functioning.

  5. Power in EEG bands

    Time frame: Immediately after the intervention

    Analysis of EEG spectrum bands

  6. Event-related potentials amplitude

    Time frame: Immediately after the intervention

    Amplitude, in microvolts, of event-related brain potentials

  7. Event-related potentials latency

    Time frame: Immediately after the intervention

    Latency, in milliseconds, of event-related brain potentials

Sponsors and collaborators

Lead sponsor

National Council of Scientific and Technical Research, Argentina

Other Gov

Collaborators

  • Center for Nuclear and Molecular Medicine Entre Ríos

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2023
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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