Tools for the Differential Diagnosis of Fibromyalgia Based on Cognitive Tasks

National Scientific and Technological Research Council (CONICET)

Status: Completed

Conditions: Fibromyalgia

Treatments: Other: Color Comparison Task; Other: N-back Task

Study type: Observational

Funder types: Other

Identifiers

NCT05910372

IS003981

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

Fibromyalgia Patients

Description:

Patients with primary fibromyalgia diagnosis. May include other chronic pain comorbidities, but the pain associated with those diseases should be less severe than the pain caused by fibromyalgia.

Treatment:

Other: N-back Task

Other: Color Comparison Task

Healthy Controls

Description:

Volunteers with no clinical history of chronic pain, musculoskeletal or articular disorders.

Treatment:

Other: N-back Task

Other: Color Comparison Task