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ACTIVE NOT RECRUITING
NCT05963321
NA

Cortical Excitability Modulation With ctDCS in Fibromyalgia.

Sponsor: Hospital de Clinicas de Porto Alegre

View on ClinicalTrials.gov

Summary

Fibromyalgia is a syndrome characterized by chronic generalized musculoskeletal pain, accompanied by other symptoms such as fatigue, sleep disturbance and depression. Complaints of memory deficit, cognitive dysfunction, headache and gastrointestinal disorders are also common. Although it is a relatively common syndrome, exist a limited effectiveness of the pharmacologycal treatment. However, In the last years new therapeutic and diagnostic options have been sought. This scenario includes the use of different techniques of non-invasive brain stimulation, such as transcranial direct current magnetic stimulation (tDCS) and transcranial magnetic stimulation (TMS), which have already had promising results in reducing pain. Based on the above, the objective of this research is to evaluate the effect of cerebellar tDCS on clinical measures of pain and cortical excitability in patients with fibromyalgia. In this study, the intervention consists of a single tDCS session in which two devices will be used simultaneously. The active electrode will be placed in the cerebellum and/or in the primary motor cortex and the cathode in the contralateral supraorbital region. It is expected that the application of this protocol will be able to have a modulatory effect on clinical pain measures. In addition to producing changes in cortical excitability as a reflection of the integration between the cerebellum-thalamus-cortical pathways.

Official title: Cortical Excitability Modulation With Cerebellar Transcranial Direct Current Stimulation in Fibromyalgia: a Randomized Clinical Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2023-06-15

Completion Date

2026-04-01

Last Updated

2026-01-14

Healthy Volunteers

No

Interventions

DEVICE

TDCS

Two tDCS devices will be used simultaneously. The intervention consists of a tDCS session in which the active electrode will be located in the cerebellum and/or in the primary motor cortex (4 stimulation protocols that will be implemented; active cerebellum electrode and active M1 electrode, sham cerebellum electrode and active M1 electrode, active cerebellum and sham M1 electrode, sham cerebellar electrode and sham M1 electrode) and the cathode in the contralateral supraorbital region.

Locations (2)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil