FibromyalgiactDCSNCT05963321
Cortical Excitability Modulation With ctDCS in Fibromyalgia.
A study testing TDCS in people with Fibromyalgia and Chronic Pain, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia, Chronic Pain
- What is being tested?
- TDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 2 sitesBrazil
- Study dates
- 15 Jun 2023to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90.450-120
Hospital de clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 9410000
About this study
Official title: Cortical Excitability Modulation With Cerebellar Transcranial Direct Current Stimulation in Fibromyalgia: a Randomized Clinical Trial
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.
Read the detailed description
The prevalence of fibromyalgia is approximately 2.7%, with a female-to-male ratio of 3:1. Although it is a relatively common syndrome, there are many doubts regarding its diagnosis and pathophysiology. In addition to the previously mentioned questions, this pathology has high social costs due to its association with the loss of labor productivity and it is characterized by being unresponsive to pharmacological treatment. Given the limited effectiveness of available therapeutic options, 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. In addition, TMS also allows measuring parameters that help to understand the reorganization of physiological processes. In this study, TMS is used to understand the pathophysiology of fibromyalgia, while tDCS allows modulating the excitability of the neuronal membrane potential of cortical and subcortical neural networks, producing a neuromodulatory effect of the top-down type. According to the evidence, the greatest impact on pain is associated with stimulation of the primary motor cortex (M1), but recent studies have shown the possible relationship between stimulation of extracerebral regions such as the cerebellum, with an analgesic effect present in healthy individuals and patients with different pathologies. In the same way, the cortical excitability measures obtained through TMS allow us to identify the imbalance between inhibitory and excitatory systems, related to pain perception and the analgesic response of endogenous mechanisms. In this research, our objective is to evaluate the effect of cerebellar tDCS on clinical measures of pain and cortical excitability in patients with fibromyalgia. This is a randomized, double-blind, controlled clinical trial, parallel, which has as its primary outcome, the evaluation of the variations in motor evoked potential (MEP) (neurophysiological outcome) and the numerical pain scale (NPS) as a clinical outcome. Secondary outcomes include the silent period (CSP), intra-cortical facilitation (ICF) and intra-cortical inhibition (ICI) obtained through TMS, the function of the descending modulatory path of pain by the conditioned modulation test (CPM test), the Brief Pain Inventory (BPI) and the pain thresholds by heat, pressure and cold. 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 (4 stimulation protocols that will be implemented; active cerebellum electrode - active M1 electrode, sham cerebellum electrode - active M1 electrode, active cerebellum-M1 sham electrode, sham cerebellum electrode-M1 sham electrode) and the cathode in the contralateral supraorbital region. The equipment will apply a current of 2 mA for 20 minutes. In total, there will be 92 patients, divided into 4 intervention blocks and composed of 23 individuals each.
- Conditions
- Fibromyalgia, Chronic Pain
- Being tested
- TDCS
- Keywords
- Fibromyalgia, Cerebellum, Transcranial direct current magnetic stimulation, Transcranial magnetic stimulation
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDCSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: TDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Up to 60 minutes after tDCS onset.
Secondary outcomes (4)
Change in the Brief Pain Inventory (BPI) score
It is a quick, simple, and easy-to-apply questionnaire that allows a multidimensional pain assessment to be carried out. The BPI consists of 15 items that determine the severity, existence, location, functional interference, applied therapeutic strategies, and efficacy of pain treatment. In the research, this questionnaire will be implemented at baseline, 8 and 15 days after tDCS onset.
Measured: Up to 15 days after tDCS onset.
Change in Function of corticospinal pathway
Measures of cortical excitability obtained through TMS include the silent period (CSP),intra-cortical facilitation (ICF) and intra-cortical inhibition (SICI). The TMS measures will be performed at two different times: before and after tDCS onset.
Measured: Up to 60 minutes after tDCS onset.
change in conditioned pain modulation (CPM)
Conditioned pain modulation (CPM) is an experimental psychophysical measure that assesses supraspinal descending inhibitory mechanisms of pain modulation. In practice, a constant noxious stimulus (conditioning stimulus) is applied to one part of the body and a phasic stimulus (stimulus to be tested) to a distant part of the body before, during, and after the conditioning stimulus. The CPM is analyzed through the reduction that occurs in the perception of pain in the test stimulus.The conditioned pain modulation will be performed at two different times: before and after the single tDCS onset.
Measured: Up to 60 minutes after tDCS onset.
Change in the quantitative sensory test (QST)
The quantitative sensory test (QST) evaluates the function of myelinated, small and unmyelinated fibers, also including the function of the spinothalamic tract and nociceptive fibers. In addition, the QST represents a non-invasive method, which determines the gain or loss of sensory perception in response to external stimuli of controlled intensity in a previously determined body area.
The following tests will be carried out in the research:
- Painful pressure threshold: performed with a pressure algometer, applied on the upper extremity.
- Cold pressor test: the patient puts his extremity in a container with ice. The tolerance time will be determined.
- Sensation of heat: using a heat electrode applied to the extremity corresponding to the sensitive alteration, the first sensation of heat and the painful threshold of light, medium and maximum heat will be evaluated.
The QST measures will be performed at two different times; before and after the tDCS onset.
Measured: Up to 60 minutes after tDCS onset.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start15 Jun 2023
- Primary completion31 Dec 2024
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wolnei Caumo, PhD, Study director, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963321
- Sponsor's protocol ID
- 2022-0504
- Acronym
- ctDCS
- Status last verified
- Jan 2026
- First submitted
- 26 Jun 2023
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25231432van 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.
PubMed 27242469Nitsche 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.
PubMed 20633386Lefaucheur 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.
PubMed 27866120Lefaucheur JP. Transcranial magnetic stimulation. Handb Clin Neurol. 2019;160:559-580. doi: 10.1016/B978-0-444-64032-1.00037-0.
PubMed 31277876Ugawa 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.
PubMed 1816387Betancur 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.
PubMed 41130992
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Excitability Modulation With Cerebellar Transcranial Direct Current Stimulation in Fibromyalgia: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05963321
- Acronym / sponsor ID
- ctDCS / 2022-0504
- Conditions
- Fibromyalgia, Chronic Pain
- Keywords
- Fibromyalgia, Cerebellum, Transcranial direct current magnetic stimulation, Transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The prevalence of fibromyalgia is approximately 2.7%, with a female-to-male ratio of 3:1. Although it is a relatively common syndrome, there are many doubts regarding its diagnosis and pathophysiology. In addition to the previously mentioned questions, this pathology has high social costs due to its association with the loss of labor productivity and it is characterized by being unresponsive to pharmacological treatment. Given the limited effectiveness of available therapeutic options, 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. In addition, TMS also allows measuring parameters that help to understand the reorganization of physiological processes. In this study, TMS is used to understand the pathophysiology of fibromyalgia, while tDCS allows modulating the excitability of the neuronal membrane potential of cortical and subcortical neural networks, producing a neuromodulatory effect of the top-down type. According to the evidence, the greatest impact on pain is associated with stimulation of the primary motor cortex (M1), but recent studies have shown the possible relationship between stimulation of extracerebral regions such as the cerebellum, with an analgesic effect present in healthy individuals and patients with different pathologies. In the same way, the cortical excitability measures obtained through TMS allow us to identify the imbalance between inhibitory and excitatory systems, related to pain perception and the analgesic response of endogenous mechanisms. In this research, our objective is to evaluate the effect of cerebellar tDCS on clinical measures of pain and cortical excitability in patients with fibromyalgia. This is a randomized, double-blind, controlled clinical trial, parallel, which has as its primary outcome, the evaluation of the variations in motor evoked potential (MEP) (neurophysiological outcome) and the numerical pain scale (NPS) as a clinical outcome. Secondary outcomes include the silent period (CSP), intra-cortical facilitation (ICF) and intra-cortical inhibition (ICI) obtained through TMS, the function of the descending modulatory path of pain by the conditioned modulation test (CPM test), the Brief Pain Inventory (BPI) and the pain thresholds by heat, pressure and cold. 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 (4 stimulation protocols that will be implemented; active cerebellum electrode - active M1 electrode, sham cerebellum electrode - active M1 electrode, active cerebellum-M1 sham electrode, sham cerebellum electrode-M1 sham electrode) and the cathode in the contralateral supraorbital region. The equipment will apply a current of 2 mA for 20 minutes. In total, there will be 92 patients, divided into 4 intervention blocks and composed of 23 individuals each.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active cerebellum electrode and active M1 electrode | Active comparator | Device: TDCS* 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. |
| Sham cerebellar electrode and active M1 electrode | Active comparator | Device: TDCS* 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 cerebellum electrode and sham M1 electrode | Active comparator | Device: TDCS* 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 cerebellar electrode and sham M1 electrode | Sham comparator | Device: TDCS* 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TDCSTwo 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. | Device | 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 |
Primary outcome
Change in motor evoked potential (MEP).
Time frame: Up to 60 minutes after tDCS onset.
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.
Change in pain level
Time frame: Up to 60 minutes after tDCS onset.
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).
4 secondary outcomes
Change in the Brief Pain Inventory (BPI) score
Time frame: Up to 15 days after tDCS onset.
Change in Function of corticospinal pathway
Time frame: Up to 60 minutes after tDCS onset.
change in conditioned pain modulation (CPM)
Time frame: Up to 60 minutes after tDCS onset.
Change in the quantitative sensory test (QST)
Time frame: Up to 60 minutes after tDCS onset.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Background: PubMed 25231432Ferrucci 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.
- Background: PubMed 27242469van 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.
- Background: PubMed 20633386Nitsche 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.
- Background: PubMed 27866120Lefaucheur 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.
- Background: PubMed 31277876Lefaucheur JP. Transcranial magnetic stimulation. Handb Clin Neurol. 2019;160:559-580. doi: 10.1016/B978-0-444-64032-1.00037-0.
- Background: PubMed 1816387Ugawa 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.
- Derived from this study: PubMed 41130992Betancur 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolnei Caumo, PhD study director
Hospital de Clinicas de Porto Alegre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TDCS in people with Fibromyalgia and Chronic Pain, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in motor evoked potential (MEP). (time frame: Up to 60 minutes after tDCS onset.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05963321, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.