Impact of Susceptibility to Placebo on the Effect of Transcranial Direct Current Stimulation (tDCS) in Fibromyalgia

NCT05845528 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-01-08

No results posted yet for this study

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.

Conditions

  • Fibromyalgia

Interventions

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

DEVICE

a- tDCS

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

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Wolnei Caumo, PhD · Hospital de Clinicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-16
Primary Completion
2023-04-25
Completion
2024-06-20

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05845528 on ClinicalTrials.gov