Cortical Excitability Modulation With ctDCS in Fibromyalgia.

NCT05963321 | Active Not Recruiting

• 1 other identifier: 2022-0504
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Fibromyalgia; Chronic Pain

Keywords

Fibromyalgia; Cerebellum; Transcranial direct current magnetic stimulation; Transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (2)

• Change in motor evoked potential (MEP).

  Change from before and after tDCS onset on MEP. Assessed by a variation in the amplitude obtained by 20 stimuli with an intensity of 120% of the MT. The MEP will be considered the arithmetic mean of the amplitude of the wave recorded by the EMG.

  Up to 60 minutes after tDCS onset.

• Change in pain level

  The study assessed the change in pain scores before and after tDCS onset using the Numerical Pain Scale (NPS). The NPS scores range from zero (no pain) to a maximum of ten (severe pain).

  Up to 60 minutes after tDCS onset.

Secondary Outcomes (4)

• Change in the Brief Pain Inventory (BPI) score

  Up to 15 days after tDCS onset.

• Change in Function of corticospinal pathway

  Up to 60 minutes after tDCS onset.

• change in conditioned pain modulation (CPM)

  Up to 60 minutes after tDCS onset.

• Change in the quantitative sensory test (QST)

  Up to 60 minutes after tDCS onset.

Other Outcomes (1)

• levels of Brain derived neurotrophic factor

  Blood samples will be collected at baseline, before tDCS onset.

Study Arms (4)

Active cerebellum electrode and active M1 electrode

ACTIVE COMPARATOR

* 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.

Device: TDCS

Sham cerebellar electrode and active M1 electrode

ACTIVE COMPARATOR

* 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.

Device: TDCS

Active cerebellum electrode and sham M1 electrode

ACTIVE COMPARATOR

* 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.

Device: TDCS

Sham cerebellar electrode and sham M1 electrode

SHAM COMPARATOR

* 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.

Device: TDCS

Interventions

TDCS DEVICE

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.

Active cerebellum electrode and active M1 electrode; Active cerebellum electrode and sham M1 electrode; Sham cerebellar electrode and active M1 electrode; Sham cerebellar electrode and sham M1 electrode

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Reside outside Porto Alegre area.
• Confirmed pregnancy
• Contraindications to TMS and tDCS: metallic implant in the brain; medical devices implanted in the brain, heart pacemaker; cochlear implant; history of alcohol or drug abuse in the last 6 months; neurological pathologies; hx of head trauma or neurosurgery; decompensated systemic diseases and chronic inflammatory diseases (lupus, rheumatoid arthritis, Reiter's syndrome); uncompensated hypothyroidism; personal history of cancer, past or undergoing treatment.
• Participants with diagnosis or recent contact with COVID will be excluded.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (2)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90.450-120, Brazil

Location

Hospital de clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 9410000, Brazil

Location

Related Publications (7)

• Ferrucci R, Cortese F, Priori A. Cerebellar tDCS: how to do it. Cerebellum. 2015 Feb;14(1):27-30. doi: 10.1007/s12311-014-0599-7.

  PMID: 25231432 BACKGROUND

• van Dun K, Bodranghien FC, Marien P, Manto MU. tDCS of the Cerebellum: Where Do We Stand in 2016? Technical Issues and Critical Review of the Literature. Front Hum Neurosci. 2016 May 11;10:199. doi: 10.3389/fnhum.2016.00199. eCollection 2016.

  PMID: 27242469 BACKGROUND

• Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.

  PMID: 20633386 BACKGROUND

• Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.

  PMID: 27866120 BACKGROUND

• Lefaucheur JP. Transcranial magnetic stimulation. Handb Clin Neurol. 2019;160:559-580. doi: 10.1016/B978-0-444-64032-1.00037-0.

  PMID: 31277876 BACKGROUND

• Ugawa Y, Day BL, Rothwell JC, Thompson PD, Merton PA, Marsden CD. Modulation of motor cortical excitability by electrical stimulation over the cerebellum in man. J Physiol. 1991 Sep;441:57-72. doi: 10.1113/jphysiol.1991.sp018738.

  PMID: 1816387 BACKGROUND

• Betancur DFA, da Graca Lopes Tarrago M, Franca BR, Bueno GB, Gomes J, Coelho ML, Venturini CL, Torres ILS, Fregni F, Bock H, Caumo W. Cortical excitability and analgesic effects of multisite transcranial direct current stimulation targeting the motor cortex and cerebellum in fibromyalgia. Sci Rep. 2025 Oct 23;15(1):37067. doi: 10.1038/s41598-025-20769-1.

  PMID: 41130992 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Wolnei Caumo, PhD

  Hospital de Clinicas de Porto Alegre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 27, 2023
• Study Start: June 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: April 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)