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| Name | Class |
|---|---|
| Center for Nuclear and Molecular Medicine Entre RÃos | UNKNOWN |
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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Healthy Controls | Volunteers with no clinical history of chronic pain, musculoskeletal or articular disorders. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fibromyalgia Impact Questionnaire-Revised version (FIQR) | Instrument for the assessment and evaluation of fibromyalgia patient's status | 10 minutes before the intervention |
| Symptoms Impact Questionnaire (SIQ) |
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Inclusion Criteria:
Fibromyalgia patients:
Healthy controls:
Exclusion Criteria:
Fibromyalgia patients:
Healthy controls:
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The cohorts of patients and healthy controls wil be selected from the city of Paraná and surrounding areas. Through the ONG "Fibromialgia Entre RÃos 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
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| Name | Affiliation | Role |
|---|---|---|
| José A Biurrun Manresa, PhD | National Council of Scientific and Technical Research, Argentina (CONICET) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Nuclear and Molecular Medicine Entre RÃos (CEMENER) | Oro Verde | Entre RÃos Province | 3100 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20461783 | Background | 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. | |
| 25583051 | Background |
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Individual participant data (IPD) will be made available on the 'Open Science Framework' after undergoing the process of anonymization to remove any participant-identifying information. The data will consist of the raw EEG signals and raw behavioral responses to cognitive tasks. Additionally, the statistical analysis and Jupyter notebooks used to process the data will also be shared
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.
The data will be publicly available.
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| 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. |
|
Instrument to assess healthy control's status regarding relevant clinical symptoms experienced in the last week.
| 10 minutes before the intervention |
| Hospital Anxiety and Depression Scale (HADS) | Widely used instrument to evaluate anxiety and depression | 10 minutes before the intervention |
| 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 |
| Power in EEG bands | Analysis of EEG spectrum bands | Immediately after the intervention |
| Event-related potentials amplitude | Amplitude, in microvolts, of event-related brain potentials | Immediately after the intervention |
| Event-related potentials latency | Latency, in milliseconds, of event-related brain potentials | Immediately after the intervention |
| 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. |
| 29388512 | 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. |
| 29308988 | 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. |
| 33240059 | 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. |
| D009422 |
| Nervous System Diseases |