Trial · NCT02639533
Brain Response to Single Dose of Pregabalin in Fibromyalgia
NCT02639533, Phase 2, Phase 3, Completed, Hospital de Clinicas de Porto Alegre
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Brain Response to Single Dose of Pregabalin in Fibromyalgia. Trials, record NCT02639533. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02639533
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brain Response to Single Dose of Pregabalin in Fibromyalgia
- NCT number
- NCT02639533
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 27 participants, actual
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Conditions
- Fibromyalgia
- Interventions
- Pregabalin, Placebo
- First posted
- 2015-12-24
- Last updated
- 2018-02-08
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cortical Excitability: Intracortical Inhibition. | 1 hour after intervention | 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. |
| Primary | Cortical hemodynamics: Oxy-hemoglobin concentration (mM/L) | 1 hour after intervention | 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. |
| Secondary | Pain | 1 hour after intervention | Assessed with the Visual Analog Scale |
| Secondary | Heat Pain Threshold | 1 hour after intervention | 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. |
| Secondary | Pressure Pain Threshold | 1 hour after intervention | 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 . |
| Secondary | Maximal Heat Pain Tolerance | 1 hour after intervention | 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. |
| Secondary | Conditioned pain modulation | 1 hour after intervention | 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. |
| Secondary | Serum Brain Derived Neurotrophic Factor (BDNF) | Baseline and 2 hours after intervention | Blood samples will be gathered at baseline and 2 hours after receiving the intervention to quantify the serum BDNF concentration (ng/mL). |
| Secondary | Serum Protein S100B | Baseline and 2 hours after intervention | Blood samples will be gathered at baseline and 2 hours after receiving the intervention to quantify the serum S100B concentration (pg/mL). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30510505 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02639533
GET https://conductscience.org/api/trials/v1/NCT02639533/registered