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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Right-handed women aged 18 to 65 years; who can read and write

• Confirmed diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology (2010-2016).

• Pain score equal to or greater than 4 on the Numerical Pain Scale (Score 0-10) on most days in the last 3 months.

Locations
Other Locations
Brazil
Hospital de clinicas de Porto Alegre
RECRUITING
Porto Alegre
Hospital de Clinicas de Porto Alegre
RECRUITING
Porto Alegre
Contact Information
Primary
Wolnei Caumo, PhD
wcaumo@hcpa.edu.br
55 51 33596377
Time Frame
Start Date: 2023-06-15
Estimated Completion Date: 2024-12
Participants
Target number of participants: 92
Treatments
Active_comparator: Active cerebellum electrode and active M1 electrode
* The patient will receive active cerebellar stimulation with the anode electrode positioned in the cerebellum and active cortical stimulation with the anode electrode placed in the primary motor cortex.~* In both cerebellar and cortical stimulations, the cathode will be positioned in the contralateral supraorbital region.~* The equipment will apply a current of 2 mA for 20 minutes.
Active_comparator: Sham cerebellar electrode and active M1 electrode
* The patient will receive sham cerebellar stimulation with the anode electrode positioned in the cerebellum and active cortical stimulation with the anode electrode placed in the primary motor cortex.~* In both cerebellar and cortical stimulations, the cathode will be positioned in the contralateral supraorbital region.~* The equipment will apply a current of 2 mA for 20 minutes.
Active_comparator: Active cerebellum electrode and sham M1 electrode
* The patient will receive active cerebellar stimulation with the anode electrode positioned in the cerebellum and sham cortical stimulation with the anode electrode placed in the primary motor cortex.~* In both cerebellar and cortical stimulations, the cathode will be positioned in the contralateral supraorbital region.~* The equipment will apply a current of 2 mA for 20 minutes.
Sham_comparator: Sham cerebellar electrode and sham M1 electrode
* The patient will receive sham cerebellar stimulation with the anode electrode positioned in the cerebellum and sham cortical stimulation with the anode electrode placed in the primary motor cortex.~* In both cerebellar and cortical stimulations, the cathode will be positioned in the contralateral supraorbital region.~* The equipment will apply a current of 2 mA for 20 minutes.
Sponsors
Leads: Hospital de Clinicas de Porto Alegre

This content was sourced from clinicaltrials.gov