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Cortical Excitability Modulation With ctDCS in Fibromyalgia. (ctDCS)

Primary Purpose

Fibromyalgia, Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
TDCS
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Cerebellum, Transcranial direct current magnetic stimulation, Transcranial magnetic stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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 6 on the Numerical Pain Scale (Score 0-10) on most days in the last 3 months. Exclusion Criteria: 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.

Sites / Locations

  • Hospital de Clinicas de Porto AlegreRecruiting
  • Hospital de clinicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Active cerebellum electrode and active M1 electrode

Sham cerebellar electrode and active M1 electrode

Active cerebellum electrode and sham M1 electrode

Sham cerebellar electrode and sham M1 electrode

Arm Description

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.

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.

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

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

Outcomes

Primary Outcome Measures

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.
Change in pain level
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
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
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)
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)
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.

Full Information

First Posted
June 26, 2023
Last Updated
July 18, 2023
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT05963321
Brief Title
Cortical Excitability Modulation With ctDCS in Fibromyalgia.
Acronym
ctDCS
Official Title
Cortical Excitability Modulation With Cerebellar Transcranial Direct Current Stimulation in Fibromyalgia: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Chronic Pain
Keywords
Fibromyalgia, Cerebellum, Transcranial direct current magnetic stimulation, Transcranial magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active cerebellum electrode and active M1 electrode
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham cerebellar electrode and active M1 electrode
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Active cerebellum electrode and sham M1 electrode
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sham cerebellar electrode and sham M1 electrode
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
TDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in motor evoked potential (MEP).
Description
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.
Time Frame
Up to 60 min after tDCS onset.
Title
Change in pain level
Description
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)
Time Frame
Up to 60 min after tDCS onset.
Secondary Outcome Measure Information:
Title
Change in the Brief Pain Inventory (BPI) score
Description
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.
Time Frame
Up to 15 days after tDCS onset.
Title
Change in other measures obtained through transcranial magnetic stimulation
Description
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.
Time Frame
Up to 60 min after tDCS onset.
Title
change in conditioned pain modulation (CPM)
Description
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.
Time Frame
Up to 60 min after tDCS onset.
Title
Change in the quantitative sensory test (QST)
Description
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.
Time Frame
Up to 60 min after tDCS onset.
Other Pre-specified Outcome Measures:
Title
levels of Brain derived neurotrophic factor
Description
Blood samples will be collected at baseline in order to determine BDNF serum levels using a standardized kit
Time Frame
Blood samples will be collected at baseline, before tDCS onset.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 6 on the Numerical Pain Scale (Score 0-10) on most days in the last 3 months. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wolnei Caumo, PhD
Phone
55 51 33596377
Ext
6377
Email
wcaumo@hcpa.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolnei Caumo, PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90.450-120
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolnei Caumo, PhD
Phone
+5551 3359 8083
Email
wcaumo@hcpa.edu.br
First Name & Middle Initial & Last Name & Degree
Wolnei Caumo, PhD
Facility Name
Hospital de clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
9410000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Fernando Arias Betancur
Phone
51997511560
Email
dbetancur@hcpa.edu.br

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25231432
Citation
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.
Results Reference
background
PubMed Identifier
27242469
Citation
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.
Results Reference
background
PubMed Identifier
20633386
Citation
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.
Results Reference
background
PubMed Identifier
27866120
Citation
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.
Results Reference
background
PubMed Identifier
31277876
Citation
Lefaucheur JP. Transcranial magnetic stimulation. Handb Clin Neurol. 2019;160:559-580. doi: 10.1016/B978-0-444-64032-1.00037-0.
Results Reference
background
PubMed Identifier
1816387
Citation
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.
Results Reference
background

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Cortical Excitability Modulation With ctDCS in Fibromyalgia.

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