Trial Summary
What is the purpose of this trial?Fibromyalgia (FM) is a chronic musculoskeletal pain disorder with unknown causes. Our previous studies showed abnormal sensations of second pain (wind-up), indicating central hypersensitivity as an important mechanism of FM. Triggering events have been implicated as the cause of central hypersensitivity.
Do I need to stop my current medications for the trial?
Yes, if you are a fibromyalgia patient, you must stop taking your fibromyalgia-related medications for at least one day before the visit.
How is the PASAT treatment different from other treatments for fibromyalgia?
The PASAT treatment is unique because it focuses on improving cognitive functions like working memory and attention, which are often impaired in fibromyalgia patients. Unlike typical pain management treatments, PASAT targets the brain's ability to process information and manage tasks, potentially addressing cognitive deficits associated with the condition.
12345Eligibility Criteria
This trial is for individuals diagnosed with Fibromyalgia (FM) who have experienced pain for more than 3 months and meet specific diagnostic criteria. Healthy people without chronic pain can also join as controls. Participants should not have chronic diseases or significant vision loss, and FM patients must pause their medications for at least a day before the visit.Inclusion Criteria
I am healthy, without chronic pain, and match the age and sex criteria.
I have been diagnosed with fibromyalgia and have had pain for more than 3 months.
Exclusion Criteria
I am willing to stop my fibromyalgia medication for at least one day before my visit.
I have a long-term illness like cancer or diabetes.
Significant vision loss not corrected by eye wear
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Evaluation
Baseline evaluation of light and pain sensitivity using QST examinations and VEP
1-2 weeks
1 visit (in-person)
Experimental Task
Participants undergo the PASAT task to assess sensory testing responses
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after experimental tasks
4 weeks
Participant Groups
The study is testing how people with FM respond to a Paced Auditory Serial Addition Task (PASAT), which may help understand central hypersensitivity—a key mechanism in FM that relates to abnormal pain perception.
1Treatment groups
Experimental Treatment
Group I: Effects of PASAT on Sensory TestingExperimental Treatment1 Intervention
After baseline evaluation of light and pain sensitivity FM subjects and controls will undergo the PASAT task. This task consists of responding to a rapid presentation of numbers by ear phones. Subjects are asked to add each 2 consecutive numbers and provide a response each time the sum is equal to 13. This test will last several minutes and delivered at increasing speed.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of FloridaGainesville, FL
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Who Is Running the Clinical Trial?
University of FloridaLead Sponsor
References
Temporal preparation and inhibitory deficit in fibromyalgia syndrome. [2019]Cognitive deficits in fibromyalgia may be specifically related to controlled processes, such as those measured by working memory or executive function tasks. This hypothesis was tested here by measuring controlled temporal preparation (temporal orienting) during a response inhibition (go no-go) task. Temporal orienting effects (faster reaction times for targets appearing at temporally attended vs. unattended moments) and response inhibition were impaired in fibromyalgia compared to the control group. It is concluded that frontal networks underlying attentional control (temporal orienting and response inhibition) can be a dysfunctional neurocognitive mechanism in fibromyalgia.
Altered processing of pain-related information in patients with fibromyalgia. [2006]Pressure pain thresholds (PPTs) and event-related potentials (ERPs) elicited by emotional words were analyzed in 12 patients with fibromyalgia (FM) and 12 matched healthy subjects. PPTs were assessed at the middle finger of both hands, before and after the experiment. Overall, FM patients and healthy subjects did not differ in PPT. Nevertheless, FM patients as compared with healthy controls were characterized by a significant enhancement of pain sensitivity from the beginning to the end of the experiment indicating a long lasting sensitization due to repeated stimulation. ERPs were recorded during a language decision task where subjects had to react to unpleasant pain-related and emotionally neutral words depending on syntactic or orthographic cues. An emotional category effect was observed on N400 and P300 components of the ERP, indicating that unpleasant words elicited more positive amplitudes than neutral words. A significant group effect was observed on P200 amplitudes, showing reduced amplitudes in FM patients as compared to healthy controls. Furthermore, unpleasant pain-related compared to neutral words triggered significantly enhanced late positive slow waves in healthy controls, while a comparable effect was not found in FM patients. The ERP and PPT data suggest that FM patients are characterized by an altered cognitive processing of pain-related information and by an abnormal adaptation to mechanical pain stimuli, respectively.
Effects of intensity, attention and medication on auditory-evoked potentials in patients with fibromyalgia. [2021]Fibromyalgia (FM) has been associated to an increased processing of somatosensory stimuli, but its generalization to other sensory modalities is under discussion. To clarify this, we studied auditory event-related potentials (AEPs) to stimuli of different intensity in patients with FM and healthy controls (HCs), considering the effects of attention mechanisms and medication. We performed two experiments: In study 1 (n = 50 FM, 60 HCs), the stimuli were presented randomly within the sequence; in study 2 (n = 28 FM, 30 HCs), they were presented in blocks of the same intensity. We analyzed intensity and group effects on N1-P2 amplitude and, only for the FM group, the effect of medication and the correlation between AEPs and clinical variables. Contrary to the expectation, the patients showed a trend of reduced AEPs to the loudest tones (study 1) or no significant differences with the HCs (study 2). Medication with central effects significantly reduced AEPs, while no significant relationships between the N1-P2 amplitude/intensity function and patients' symptoms were observed. The findings do not provide evidence of augmented auditory processing in FM. Nevertheless, given the observed effect of medication, the role of sensory amplification as an underlying pathophysiological mechanism in fibromyalgia cannot be discarded.
Cognitive dysfunction in fibromyalgia: slow access to the mental lexicon. [2015]Lexical access speed, the time needed for the brain to access the catalogue of words in long-term memory, is assumed to provide a foundation for a broad array of cognitive operations. It was hypothesized that deficits in lexical speed are likely to play a central role in deficiencies in cognitive performance of patients with fibromyalgia, who as a group show deficits in lexical speed. This was tested in a sample of 209 patients with fibromyalgia and in 72 control patients with memory deficits. Participants completed the Stroop word-naming measure of lexical access speed and 12 neurocognitive measures. Deficit in lexical access speed occurred at approximately twice the frequency (48.3% vs 25.0%) in fibromyalgia. The average delay in speed of lexical access was 171 msec. in fibromyalgia and 163 msec. in controls. Those with deficits in lexical access speed displayed deficiencies on 10 of 12 cognitive measures in the fibromyalgia group, and on 8 of 12 cognitive measures in the control group. The premise that lexical access speed is disproportionately present in fibromyalgia and serves as a foundation for a wide array of cognitive operations is supported.
MoCA vs. MMSE of Fibromyalgia Patients: The Possible Role of Dual-Task Tests in Detecting Cognitive Impairment. [2021]Fibromyalgia is a syndrome that is characterized by widespread pain; fatigue; stiffness; reduced physical fitness; sleep disturbances; psychological symptoms, such as anxiety and depression; and deficits in cognitive functions, such as attention, executive function, and verbal memory deficits. It is important to analyze the potentially different performance on the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) test in patients with fibromyalgia as well as examine the relationship of that performance with physical and cognitive performance. A total of 36 women with fibromyalgia participated in the study. Participants completed the MoCA test, the MMSE, and the TUG physical fitness test under dual-task conditions. The results obtained on cognitive tests were 28.19 (1.74) on the MMSE and 25.17 (2.79) on the MoCA. The participants' performance on cognitive tests was significantly related to the results of the TUG dual-task test. In this way, cognitive performance on a dual-task test can be used to support the diagnosis of cognitive impairment in patients with fibromyalgia. The MoCA test may be a more sensitive cognitive screening tool than the MMSE for patients with fibromyalgia.