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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05845528
Other study ID # 20200383
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 16, 2021
Est. completion date November 20, 2023

Study information

Verified date April 2023
Source Hospital de Clinicas de Porto Alegre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Fibromyalgia (FM) is a syndrome characterized by generalized musculoskeletal pain, fatigue, non-restorative sleep, cognitive changes, depressive and neurovegetative symptoms. It is known that conventional pharmacological therapies produce responses with little clinical impact in more than 50% of patients. Functional alterations of the motor cortex and its connections with subcortical structures have also been demonstrated in FM. Based on the above, the objective of this research is to identify subgroups of patients with greater potential for responsiveness to treatment with a view to advancing diagnosis and treatment. In this study, the therapeutic target will be transcranial direct current stimulation (tDCS) according to the potential of responsiveness to the placebo effect, with the precise location of the stimulation area by a neuronavigation system, with the objective of counter-regulating the dysfunctional processes responsible for triggering and maintaining FM symptoms. Therefore, this clinical trial aims to compare the efficacy of anodal tDCS applied to the left dorsolateral prefrontal cortex (DLPFC) compared to simulated tDCS in FM, according to susceptibility to placebo effect and serum endorphin levels.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
s-tDCS
- Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it
a- tDCS
- Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it

Locations

Country Name City State
Brazil Hospital de Clinicas de Porto Alegre Porto Alegre Rio Grande Do Sul

Sponsors (1)

Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Clauw DJ, Arnold LM, McCarberg BH; FibroCollaborative. The science of fibromyalgia. Mayo Clin Proc. 2011 Sep;86(9):907-11. doi: 10.4065/mcp.2011.0206. — View Citation

Keeser D, Meindl T, Bor J, Palm U, Pogarell O, Mulert C, Brunelin J, Moller HJ, Reiser M, Padberg F. Prefrontal transcranial direct current stimulation changes connectivity of resting-state networks during fMRI. J Neurosci. 2011 Oct 26;31(43):15284-93. doi: 10.1523/JNEUROSCI.0542-11.2011. — View Citation

Zanette SA, Dussan-Sarria JA, Souza A, Deitos A, Torres IL, Caumo W. Higher serum S100B and BDNF levels are correlated with a lower pressure-pain threshold in fibromyalgia. Mol Pain. 2014 Jul 8;10:46. doi: 10.1186/1744-8069-10-46. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 1.Change in pain level - first phase Change from before and after the First phase of treatment on Pain scores assessed by a Numerical Pain Scale (NPS 0 to 10) (0 means no pain - 10 means the worst pain imaginable) Time Frame: 1 month
Primary Change in functional capacity - first phase The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning 1 month
Secondary Change in pain level - second phase Change from before and after the Second phase of treatment on Pain scores assessed by a visual analogue scale (VAS 0 to 100mm) (0 means no pain - 100 means the worst pain imaginable) 3 months
Secondary Change in functional capacity - second phase Change from before and after the First phase of treatment on Total score on the Brazilian Profile of Chronic Pain: Screen (BPCP:S) (range from 0 to 93; high numbers means more pain severity, interference in daily activities and emotional burden) 3 months
Secondary Change in Function of modulatory descending system Change from before and after the First phase of treatment on the score in a numerical pain scale (NPS 0-10) for a moderate heat pain stimulus to the right arm (ventral region) during a conditioned pain modulation task (CPM-task), where participant keeps the counter-lateral hand in an iced cold water (0 to 1º Celsius) 1 month
Secondary Change in Function of corticospinal pathway Change from before and after the First phase of treatment on measures of motor threshold (MT), motor evoked potential (MEP), intracortical facilitation (ICF), short intracortical inhibition (SICI), and cortical silent period (CSP) assessed with transcranial magnetic stimulation (TMS). Time Frame: 1 month
Secondary 7. Change in levels of Brain derived neurotrophic factor - BDNF Blood samples will be collected at baseline and after the First phase of intervention in order to determine BDNF serum levels using a standardized kit Time Frame: 1 month
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