Fibromyalgia Clinical Trial
Official title:
Pregabalin Acute Effects on Cortical Excitability, Psychophysical Parameters, and Serum Markers of Neuroplastic Processes in Fibromyalgia: a Placebo Controlled, Double Blinded, Randomized, Crossover Clinical Trial
Verified date | December 2015 |
Source | Hospital de Clinicas de Porto Alegre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Fibromyalgia syndrome represents a "spectrum disorder" characterized by widespread chronic
pain, fatigue, sleep disturbances, mood and cognitive alterations. The most accepted models
explaining the causes of the disease have focused on the reduced pain inhibitory systems
activity, that allow low intensity stimuli to be processed easier, and that finally amplify
pain stimuli. One of the interventions approved for Fibromyalgia is Pregabalin, which
demonstrated to be effective reducing pain. Different studies in animals have shown that it
works reducing the liberation of neuronal messengers, which slow the conduction of pain
signals. Although studies in humans have confirmed Pregabalin clinical benefits, there are
still few studies aiming to explain how it actually works in patients with fibromyalgia,
though.
A better understanding of the mechanisms by which Pregabalin reduces pain in patients with
fibromyalgia would allow designing new interventions to enhance its clinical effects. Thus,
the investigators propose to study in real-time the electrical, vascular and hormonal
response of the brain of patients with fibromyalgia who receive a single dose of Pregabalin.
The vascular response will be assessed using functional near infrared spectroscopy (fNIRS)
neuroimaging techniques. The electrical response will be assessed using Transcranial Magnetic
Stimulation (TMS). The hormonal response will be assessed in blood, measuring neurotrophins
(Brain Derived Neurotrophic Factor) and inflammatory mediators (Tumor Necrosis Factor). These
responses will be studied in consideration of the patients' characteristics that will be
assessed using validated scales.
Taken into account the above considerations, a crossover, double-blinded randomized clinical
trial is proposed. In the investigators' study, patients and healthy volunteers will be asked
to visit the investigators' laboratory in three opportunities: one for a baseline assessment,
and the other two to test the effects of either Pregabalin 150 mg PO or Placebo. All
participants will eventually receive both, Pregabalin and Placebo. In each visit a brain
hemodynamic, electrical, hormonal and clinical evaluation will be performed.
Status | Completed |
Enrollment | 27 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Fulfill ACR 2010 criteria for fibromyalgia diagnosis. - Literate. - Mean VAS for pain higher than 6 in the last 3 months. Exclusion Criteria: - Pregnancy or inadequate use of validated contraceptive method. - Contraindications for Transcranial Magnetic Stimulation. - Alcohol of drugs abuse in the last 6 months. - Any severe neurological, neurosurgical, cardiac, endocrinological, or oncological disease (current or past). - Decompensated chronic systemic disease. - Previous use of Pregabalin. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre | Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cortical Excitability: Intracortical Inhibition. | Cortical excitability parameters assessed non-invasively using paired-pulse Transcranial Magnetic Stimulation. Intracortical inhibition will be assessed using a conditioning stimuli of 80% of the motor threshold (MT) and a testing pulse of 120% the of the MT, with interstimuli interval (isi) of 2 and 4 microseconds. The Intracortical Inhibition corresponds to the ratio between the resultant potential and the motor evoked potential. | 1 hour after intervention | |
Primary | Cortical hemodynamics: Oxy-hemoglobin concentration (mM/L) | Cortical hemodynamics assessed non-invasively using functional near infrared spectroscopy. Thanks to spectroscopy principles, it is possible to safety use a light beam in the infrared spectrum to infer the concentration of hemoglobin when bonded to oxygen. Its concentration is calculated in mM/L. | 1 hour after intervention | |
Secondary | Pain | Assessed with the Visual Analog Scale | 1 hour after intervention | |
Secondary | Heat Pain Threshold | Assessed using quantitative sensory testing. Briefly, a thermode placed in subjects forearm is heated controlled by a computer. Subjects are instructed to report when perceiving the first pain. Temperatures in Celcius degrees are recorded. | 1 hour after intervention | |
Secondary | Pressure Pain Threshold | Assessed using a digital algometer. Briefly, progressive pressure is applied in subjects forearm until the first perception of pain is reported. The pressure of the first perception of pain are recorded in Kg/cm^2 . | 1 hour after intervention | |
Secondary | Maximal Heat Pain Tolerance | Assessed using quantitative sensory testing. Briefly, the thermode placed in subjects forearm is heated until subject reports maximum tolerated pain. A maximal temperature of 52 Celcius has been previously programmed for the device to stop and cool down in order to avoid unintended injuries. | 1 hour after intervention | |
Secondary | Conditioned pain modulation | The protocol for heat pain threshold is repeated while the contralateral hand is placed on iced water. The pain due to heat and cold reported on a Visual Analog Scale are recorded. | 1 hour after intervention | |
Secondary | Serum Brain Derived Neurotrophic Factor (BDNF) | Blood samples will be gathered at baseline and 2 hours after receiving the intervention to quantify the serum BDNF concentration (ng/mL). | Baseline and 2 hours after intervention | |
Secondary | Serum Protein S100B | Blood samples will be gathered at baseline and 2 hours after receiving the intervention to quantify the serum S100B concentration (pg/mL). | Baseline and 2 hours after intervention |
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