Tools for the Differential Diagnosis of Fibromyalgia Based on Cognitive Tasks

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05910372
• Other study ID #: IS003981
• Status: Recruiting
• Start date: April 25, 2023
• Est. completion date: August 1, 2023

Study information

• Verified date: June 2023
• Source: National Council of Scientific and Technical Research, Argentina
• Contact: Elizabeth L Young, Bioing.
• Phone: +54(343)4975100
• Email: elizabeth.young[@]uner.edu.ar
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Color Comparison Task
Participants are presented with a series of colored squares and are instructed to compare the colors of two sequentially presented stimuli.
• N-back Task
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.

Locations

Country	Name	City	State
Argentina	Center for Nuclear and Molecular Medicine Entre Ríos (CEMENER)	Oro Verde	Entre Ríos

Sponsors (2)

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

Country where clinical trial is conducted

Argentina, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fibromyalgia Impact Questionnaire-Revised version (FIQR)	Instrument for the assessment and evaluation of fibromyalgia patient's status	10 minutes before the intervention
Secondary	Symptoms Impact Questionnaire (SIQ)	Instrument to assess healthy control's status regarding relevant clinical symptoms experienced in the last week.	10 minutes before the intervention
Secondary	Hospital Anxiety and Depression Scale (HADS)	Widely used instrument to evaluate anxiety and depression	10 minutes before the intervention
Secondary	Brief Pain Inventory-Short Form (BPI-SF)	It is an instrument to assess the severity of pain and its impact on functioning.	10 minutes before the intervention
Secondary	Power in EEG bands	Analysis of EEG spectrum bands	Immediately after the intervention
Secondary	Event-related potentials amplitude	Amplitude, in microvolts, of event-related brain potentials	Immediately after the intervention
Secondary	Event-related potentials latency	Latency, in milliseconds, of event-related brain potentials	Immediately after the intervention