FibromyalgiaNCT05910372
Tools for the Differential Diagnosis of Fibromyalgia Based on Cognitive Tasks
An observational study of Fibromyalgia, run by National Council of Scientific and Technical Research, Argentina at 1 site in Argentina.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Color Comparison Task and N-back Task
- How many people
- 30 participants
- Where
- 1 siteArgentina
- Study dates
- 25 Apr 2023to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- 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:
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
Argentina1 site
Center for Nuclear and Molecular Medicine Entre Ríos (CEMENER)
Oro Verde, Entre Ríos Province, 3100
About this study
Official title: Development of Complementary Tools for the Differential Diagnosis of Fibromyalgia Based on Cognitive Task Performance
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
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Color Comparison Task, N-back Task
- Keywords
- Contralateral Delay Activity, Electroencephalography, Cognitive task, Biomarker
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Color Comparison TaskOther
Participants are presented with a series of colored squares and are instructed to compare the colors of two sequentially presented stimuli.
N-back TaskOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Color Comparison Task; Other: N-back Task | |
| Healthy Controls | Volunteers with no clinical history of chronic pain, musculoskeletal or articular disorders. Receives: Other: Color Comparison Task; Other: N-back Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of correct answers in the Color Comparison task
Percentage of correct answers over total number of trial in the Color Comparison Task
Measured: Immediately after the intervention
Secondary outcomes (7)
Fibromyalgia Impact Questionnaire-Revised version (FIQR)
Instrument for the assessment and evaluation of fibromyalgia patient's status
Measured: 10 minutes before the intervention
Symptoms Impact Questionnaire (SIQ)
Instrument to assess healthy control's status regarding relevant clinical symptoms experienced in the last week.
Measured: 10 minutes before the intervention
Hospital Anxiety and Depression Scale (HADS)
Widely used instrument to evaluate anxiety and depression
Measured: 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.
Measured: 10 minutes before the intervention
Power in EEG bands
Analysis of EEG spectrum bands
Measured: Immediately after the intervention
Event-related potentials amplitude
Amplitude, in microvolts, of event-related brain potentials
Measured: Immediately after the intervention
Event-related potentials latency
Latency, in milliseconds, of event-related brain potentials
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start25 Apr 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Council of Scientific and Technical Research, Argentina
- Sponsor type
- Other government
- Collaborators
- Center for Nuclear and Molecular Medicine Entre Ríos
- Responsible party
- Principal investigator, José Biurrun Manresa, Advanced Bionics
- Investigators
- José A Biurrun Manresa, PhD, Principal investigator, National Council of Scientific and Technical Research, Argentina (CONICET)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910372
- Sponsor's protocol ID
- IS003981
- Status last verified
- Oct 2024
- First submitted
- 25 May 2023
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 20461783Kravitz 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.
PubMed 25583051Bell 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.
PubMed 29388512Adam 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.
PubMed 29308988Shalchy 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.
PubMed 33240059
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Complementary Tools for the Differential Diagnosis of Fibromyalgia Based on Cognitive Task Performance
- ClinicalTrials.gov ID
- NCT05910372
- Acronym / sponsor ID
- IS003981
- Conditions
- Fibromyalgia
- Keywords
- Contralateral Delay Activity, Electroencephalography, Cognitive task, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Council of Scientific and Technical Research, ArgentinaOther government
- Collaborators
- Center for Nuclear and Molecular Medicine Entre Ríos
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia Patients | – | Other: Color Comparison Task, Other: N-back TaskPatients 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 | – | Other: Color Comparison Task, Other: N-back TaskVolunteers with no clinical history of chronic pain, musculoskeletal or articular disorders. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- 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.
- No history of neurological diseases, chronic pain or musculoskeletal disorders.
Key exclusion criteria (11 listed)
- 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
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Color Comparison TaskParticipants are presented with a series of colored squares and are instructed to compare the colors of two sequentially presented stimuli. | Other | Fibromyalgia Patients, Healthy Controls |
| N-back TaskParticipants 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. | Other | Fibromyalgia Patients, Healthy Controls |
Primary outcome
Percentage of correct answers in the Color Comparison task
Time frame: Immediately after the intervention
Percentage of correct answers over total number of trial in the Color Comparison Task
7 secondary outcomes
Fibromyalgia Impact Questionnaire-Revised version (FIQR)
Time frame: 10 minutes before the intervention
Symptoms Impact Questionnaire (SIQ)
Time frame: 10 minutes before the intervention
Hospital Anxiety and Depression Scale (HADS)
Time frame: 10 minutes before the intervention
Brief Pain Inventory-Short Form (BPI-SF)
Time frame: 10 minutes before the intervention
Power in EEG bands
Time frame: Immediately after the intervention
Event-related potentials amplitude
Time frame: Immediately after the intervention
Event-related potentials latency
Time frame: Immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Background: PubMed 20461783Wolfe 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.
- Background: PubMed 25583051Kravitz 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.
- Background: PubMed 29388512Bell 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.
- Background: PubMed 29308988Adam 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.
- Background: PubMed 33240059Shalchy 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José A Biurrun Manresa, PhD principal investigator
National Council of Scientific and Technical Research, Argentina (CONICET)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by National Council of Scientific and Technical Research, Argentina at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of correct answers in the Color Comparison task (time frame: Immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05910372, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.