Tools for the Differential Diagnosis of Fibromyalgia Based on Cognitive Tasks

NCT05910372 | Completed

• 1 other identifier: IS003981
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Fibromyalgia

Keywords

Contralateral Delay Activity; Electroencephalography; Cognitive task; Biomarker

Outcome Measures

Primary Outcomes (1)

• Percentage of correct answers in the Color Comparison task

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

  Immediately after the intervention

Secondary Outcomes (7)

• Fibromyalgia Impact Questionnaire-Revised version (FIQR)

  10 minutes before the intervention

• Symptoms Impact Questionnaire (SIQ)

  10 minutes before the intervention

• Hospital Anxiety and Depression Scale (HADS)

  10 minutes before the intervention

• Brief Pain Inventory-Short Form (BPI-SF)

  10 minutes before the intervention

• Power in EEG bands

  Immediately after the intervention

Study Arms (2)

Fibromyalgia Patients

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.

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

Healthy Controls

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

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

Interventions

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.

Fibromyalgia Patients; Healthy Controls

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.

Fibromyalgia Patients; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Council of Scientific and Technical Research, Argentina: lead
• Center for Nuclear and Molecular Medicine Entre Ríos: collaborator

Study Sites (1)

Center for Nuclear and Molecular Medicine Entre Ríos (CEMENER)

Oro Verde, Entre Ríos Province, 3100, Argentina

Location

Related Publications (5)

• 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.

  PMID: 20461783 BACKGROUND

• 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.

  PMID: 25583051 BACKGROUND

• 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.

  PMID: 29388512 BACKGROUND

• 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.

  PMID: 29308988 BACKGROUND

• 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.

  PMID: 33240059 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• José A Biurrun Manresa, PhD

  National Council of Scientific and Technical Research, Argentina (CONICET)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in Biomedical Science and Engineering

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 18, 2023
• Study Start: April 25, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 30, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The participant's data and the processing pipeline will be available after the data collection is finished. The supporting information (including the study protocol, the statistical analysis plan and the informed consent) will be uploaded as soon as possible.
• Access Criteria: The data will be publicly available.

Locations

AR (1)