Clinical trial NCT05910372: Tools for the Differential Diagnosis of Fibromyalgia Based on Cognitive Tasks
Official title: Development of Complementary Tools for the Differential Diagnosis of Fibromyalgia Based on Cognitive Task Performance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Keywords: Contralateral Delay Activity
Electroencephalography
Cognitive task
Biomarker
Lead sponsor: National Council of Scientific and Technical Research, Argentina
Sponsor class: OTHER_GOV
Collaborators: name: Center for Nuclear and Molecular Medicine Entre Ríos
First posted: 2023-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cohorts of patients and healthy controls wil be selected from the city of Paraná and surrounding areas. Through the ONG "Fibromialgia Entre Ríos Asociación Civil", the patients will be reached out and asked wether or not they are willing to participate. Additionally, flyer will be hung in major health facilities in the city and made public on social media. The cohort of healthy volunteers will be recruited after the patients for age, genre and socieconomic matching

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of correct answers in the Color Comparison task
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Fibromyalgia Impact Questionnaire-Revised version (FIQR)
timeFrame: 10 minutes before the intervention
measure: Symptoms Impact Questionnaire (SIQ)
timeFrame: 10 minutes before the intervention
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 10 minutes before the intervention
measure: Brief Pain Inventory-Short Form (BPI-SF)
timeFrame: 10 minutes before the intervention
measure: Power in EEG bands
timeFrame: Immediately after the intervention
measure: Event-related potentials amplitude
timeFrame: Immediately after the intervention
measure: Event-related potentials latency
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Oro Verde
country: Argentina
facility: Center for Nuclear and Molecular Medicine Entre Ríos (CEMENER)
state: Entre Ríos
Study officials:
affiliation: National Council of Scientific and Technical Research, Argentina (CONICET)
name: José A Biurrun Manresa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
citation: Kravitz HM, Katz RS. Fibrofog and fibromyalgia: a narrative review and implications for clinical practice. Rheumatol Int. 2015 Jul;35(7):1115-25. doi: 10.1007/s00296-014-3208-7. Epub 2015 Jan 13.
citation: Bell T, Trost Z, Buelow MT, Clay O, Younger J, Moore D, Crowe M. Meta-analysis of cognitive performance in fibromyalgia. J Clin Exp Neuropsychol. 2018 Sep;40(7):698-714. doi: 10.1080/13803395.2017.1422699. Epub 2018 Feb 1.
citation: Adam KCS, Robison MK, Vogel EK. Contralateral Delay Activity Tracks Fluctuations in Working Memory Performance. J Cogn Neurosci. 2018 Sep;30(9):1229-1240. doi: 10.1162/jocn_a_01233. Epub 2018 Jan 8.
citation: Shalchy MA, Pergher V, Pahor A, Van Hulle MM, Seitz AR. N-Back Related ERPs Depend on Stimulus Type, Task Structure, Pre-processing, and Lab Factors. Front Hum Neurosci. 2020 Oct 28;14:549966. doi: 10.3389/fnhum.2020.549966. eCollection 2020.