Cortical Excitability Modulation With ctDCS in Fibromyalgia.
Study Details
Study Description
Brief Summary
In this research, the objective is to evaluate the effect of cerebellar tDCS on clinical measures of pain and cortical excitability in participants with fibromyalgia. This is a randomized, double-blind, controlled clinical trial that has as its primary outcome the evaluation of the variations in motor evoked potential (MEP) (a neuropsychological outcome) and the visual analog scale (VAS) as a clinical outcome.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
In this research, the objective is to evaluate the effect of cerebellar tDCS on clinical measures of pain and cortical excitability in participants with fibromyalgia. This is a randomized, double-blind, controlled clinical trial that has as its primary outcome the evaluation of the variations in motor evoked potential (MEP) (a neuropsychological outcome) and the visual analog scale (VAS) 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 modulator 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 an 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- 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 supra orbital 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 composed of 23 individuals each.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Active cerebellum electrode and active M1 electrode Two tDCS devices will be used simultaneously. In cerebellar stimulation (active), the anodal electrode will be positioned on the right side, with the center of the sponge approximately 3 cm from the ion; on the other hand, in cortical stimulation (active), the anodal electrode will be located in the left 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
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. The equipment will apply a current of 2 mA for 20 minutes.
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Active Comparator: Sham cerebellar electrode and active M1 electrode Two tDCS devices will be used simultaneously. In cerebellar stimulation (sham), the anodal electrode will be positioned on the right side, with the center of the sponge approximately 3 cm from the ion; on the other hand, in cortical stimulation (active), the anodal electrode will be located in the left 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
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. The equipment will apply a current of 2 mA for 20 minutes.
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Active Comparator: Active cerebellum electrode and sham M1 electrode Two tDCS devices will be used simultaneously. In cerebellar stimulation (active), the anodal electrode will be positioned on the right side, with the center of the sponge approximately 3 cm from the ion; on the other hand, in cortical stimulation (sham), the anodal electrode will be located in the left 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
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. The equipment will apply a current of 2 mA for 20 minutes.
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Sham Comparator: Sham cerebellar electrode and sham M1 electrode Two tDCS devices will be used simultaneously. In cerebellar stimulation (sham), the anodal electrode will be positioned on the right side, with the center of the sponge approximately 3 cm from the ion; on the other hand, in cortical stimulation (sham), the anodal electrode will be located in the left 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
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. The equipment will apply a current of 2 mA for 20 minutes.
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Outcome Measures
Primary Outcome Measures
- Change in motor evoked potential (MEP). [Up to 60 min 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 [Up to 60 min after tDCS onset.]
Change from before and after tDCS onset on Pain scores assessed by a visual analogue scale (VAS 0 to 100mm) (0 means no pain - 100 means the worst pain imaginable)
Secondary Outcome Measures
- Change in the Brief Pain Inventory (BPI) score [Up to 15 days after tDCS onset.]
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.
- Change in other measures obtained through transcranial magnetic stimulation [Up to 60 min after tDCS onset.]
Other 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.
- change in conditioned pain modulation (CPM) [Up to 60 min after tDCS onset.]
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.
- Change in the quantitative sensory test (QST) [Up to 60 min after tDCS onset.]
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.
Other Outcome Measures
- levels of Brain derived neurotrophic factor [Blood samples will be collected at baseline, before tDCS onset.]
Blood samples will be collected at baseline in order to determine BDNF serum levels using a standardized kit
Eligibility Criteria
Criteria
Inclusion Criteria:
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Right-handed women aged 18 to 65 years; who can read and write
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Confirmed diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology (2010-2016).
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Pain score equal to or greater than 6 on the Numerical Pain Scale (Score 0-10) on most days in the last 3 months.
Exclusion Criteria:
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Reside outside Porto Alegre area.
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Confirmed pregnancy
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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.
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Participants with diagnosis or recent contact with COVID will be excluded.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande Do Sul | Brazil | 90.450-120 |
2 | Hospital de clinicas de Porto Alegre | Porto Alegre | Rio Grande Do Sul | Brazil | 9410000 |
Sponsors and Collaborators
- Hospital de Clinicas de Porto Alegre
Investigators
- Study Director: Wolnei Caumo, PhD, Hospital de Clinicas de Porto Alegre
Study Documents (Full-Text)
None provided.More Information
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.
- 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.
- Lefaucheur JP. Transcranial magnetic stimulation. Handb Clin Neurol. 2019;160:559-580. doi: 10.1016/B978-0-444-64032-1.00037-0.
- 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.
- 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.
- 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.
- 2022-0504