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Impact of Susceptibility to Placebo on the Effect of Transcranial Direct Current Stimulation (tDCS) in Fibromyalgia (FIBROTEC)

Primary Purpose

Fibromyalgia

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
s-tDCS
a- 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; tDCS; ß-endorphin; placebo effect; pain

Eligibility Criteria

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

Inclusion Criteria: Women aged 18 to 65 years; who can read and write, with a confirmed diagnosis of FM according to the American College of Rheumatology criteria (2010-2016). Pain score equal to or greater than six on the Numerical Pain Scale (NPS 0-10) on most days of the last 3 months. Exclusion Criteria: Residing outside the greater Porto Alegre area and pregnancy. Contraindications to TMS and tDCS: metallic implant in the brain; medical devices implanted in the brain, cardiac pacemakers; 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.

Sites / Locations

  • Hospital de Clinicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Respondres placebo effect

No respondres placebo effect

Arm Description

Intervention: 'Transcranial Direct Current Stimulation - tDCS The patients will receive tDCS stimulation treatment prefrontal cortex dorso lateral According to 10-20 EEG system, anode will be placed at left F3 and cathode at contralateral F4. Placebo stimulation uses a 2 milliamperes current during in the first minutes, in the 10 min and in 19 minutes.

Intervention: 'Transcranial Direct Current Stimulation - tDCS The patients will receive tDCS stimulation treatment prefrontal cortex dorso lateral According to 10-20 EEG system, anode will be placed at left F3 and cathode at contralateral F4. Active stimulation uses a 2 milliamperes current during 20 minutes.

Outcomes

Primary Outcome Measures

1.Change in pain level - first phase
Change from before and after the First phase of treatment on Pain scores assessed by a Numerical Pain Scale (NPS 0 to 10) (0 means no pain - 10 means the worst pain imaginable)
Change in functional capacity - first phase
The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning

Secondary Outcome Measures

Change in pain level - second phase
Change from before and after the Second phase of treatment on Pain scores assessed by a visual analogue scale (VAS 0 to 100mm) (0 means no pain - 100 means the worst pain imaginable)
Change in functional capacity - second phase
Change from before and after the First phase of treatment on Total score on the Brazilian Profile of Chronic Pain: Screen (BPCP:S) (range from 0 to 93; high numbers means more pain severity, interference in daily activities and emotional burden)
Change in Function of modulatory descending system
Change from before and after the First phase of treatment on the score in a numerical pain scale (NPS 0-10) for a moderate heat pain stimulus to the right arm (ventral region) during a conditioned pain modulation task (CPM-task), where participant keeps the counter-lateral hand in an iced cold water (0 to 1º Celsius)
Change in Function of corticospinal pathway
Change from before and after the First phase of treatment on measures of motor threshold (MT), motor evoked potential (MEP), intracortical facilitation (ICF), short intracortical inhibition (SICI), and cortical silent period (CSP) assessed with transcranial magnetic stimulation (TMS).
7. Change in levels of Brain derived neurotrophic factor - BDNF
Blood samples will be collected at baseline and after the First phase of intervention in order to determine BDNF serum levels using a standardized kit

Full Information

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

Unique Protocol Identification Number
NCT05845528
Brief Title
Impact of Susceptibility to Placebo on the Effect of Transcranial Direct Current Stimulation (tDCS) in Fibromyalgia
Acronym
FIBROTEC
Official Title
Impact of Susceptibility to Placebo on the Effect of Transcranial Direct Current Stimulation (tDCS) in Fibromyalgia: a Randomized Clinical Trial With Extended Home Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 16, 2021 (Actual)
Primary Completion Date
April 25, 2023 (Actual)
Study Completion Date
November 20, 2023 (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
Fibromyalgia (FM) is a syndrome characterized by generalized musculoskeletal pain, fatigue, non-restorative sleep, cognitive changes, depressive and neurovegetative symptoms. It is known that conventional pharmacological therapies produce responses with little clinical impact in more than 50% of patients. Functional alterations of the motor cortex and its connections with subcortical structures have also been demonstrated in FM. Based on the above, the objective of this research is to identify subgroups of patients with greater potential for responsiveness to treatment with a view to advancing diagnosis and treatment. In this study, the therapeutic target will be transcranial direct current stimulation (tDCS) according to the potential of responsiveness to the placebo effect, with the precise location of the stimulation area by a neuronavigation system, with the objective of counter-regulating the dysfunctional processes responsible for triggering and maintaining FM symptoms. Therefore, this clinical trial aims to compare the efficacy of anodal tDCS applied to the left dorsolateral prefrontal cortex (DLPFC) compared to simulated tDCS in FM, according to susceptibility to placebo effect and serum endorphin levels.
Detailed Description
This is clinical trial aims to compare the efficacy of anodal tDCS applied to the left dorsolateral prefrontal cortex (DLPFC) compared to simulated tDCS in FM, according to susceptibility to placebo effect and serum endorphin levels, in the following outcomes (1) treatment effectiveness, which includes daily measures recorded in an application by the Brief Pain Inventory (BPI), which allows pain assessment from a multidimensional perspective (pain intensity and interference in general activities, mood, mobility, work, personal relationships, sleep and enjoyment of life, etc.) (primary outcome). Secondary outcomes: the impact of pain on quality of life; levels of depressive symptoms; (2) Outcomes in psychophysical measures: pain threshold to electrical stimulation and heat; temporal summation to electrical stimulus; descending pain modulatory system function; (3) Identify predictors of response to the placebo effect through a hierarchical model with an analytical structure defined a 'priori', considering the hierarchical relationships between potential predictors such as: disability due to pain, catastrophism, depressive symptoms, psychiatric diagnoses, level of central sensitization, endorphin serum levels at baseline, drugs in use, etc. In this randomized, controlled, sham-controlled, parallel, double-blind clinical trial, 84 women with FM will be included, according to the criteria of the American College of Rheumatology (2016), aged between 18 and 70 years. Patients will be submitted to a simulated tDCS face-to-face session, mounted on the left DLPFC, and with a variation presented in the Numerical Verbal Pain Scale (NPS 0-10) equal to or greater than thirty percent of the baseline, the patient will be considered a high responder and below this low responder rate. This will be the criterion used to stratify randomization. They will receive 30 sessions of anodal tDCS lasting 20 min, with a current of 2 mA, applied to the left DLPFC at home. The location of the stimulation area will be done by a neuronavigation system. Patients will receive training in using the tDCS equipment. They will have access to an instructional video on tDCS and a way of communicating with the team through Whatsapp. The follow-up time after the end of stimulation will be 12 weeks as recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). Patients should respond daily to BPI and possible side effects of tDCS. Home tDCS will be carried out with equipment developed by our research group, in partnership with Biomedical Engineering at Hospital de Clínicas de Porto Alegre (HCPA), with patent registration with the National Institute of Industrial Property (INPI) under number BR2020150164500. Our hypothesis is that active tDCS has a greater effect than simulated tDCS and that stimulation on the DLPFC has a greater impact in patients with greater responsiveness to the placebo effect on psychological symptoms, functional capacity for activities of daily living and inhibitory modulatory system function. descendant of pain. It is expected that the level of cortical disinhibition assessed by TMS measurements, as well as serum ß-endorphin levels, can serve as predictors of treatment response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia; tDCS; ß-endorphin; placebo effect; pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-Blind, Randomized, Parallel Group, Sham-Controlled Clinical Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The researcher will receive equipment already programmed by a research assistant, so the researcher who will deliver the tDCS to perform stimulation will not know the programed stimulation. Patients will be instructed to discuss aspects of treatment with the respective investigator. Two independent evaluators who will not participate in the consultations where guidance on the use of tDCS will be provided will be trained to make outcome assessments in follow-up. Patients will not be aware of the type of intervention received, since the sham condition produces a stimulus, but no expected effects. In order to study the level of the blinding, at each moment of evaluation, the patient will be asked about the type of intervention that he / she believes to have received (active or simulated), and about the degree of safety in the response, using a standardized questionnaire. The blinding will be evaluated at the end of each treatment week by means of a standardized instrument.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Respondres placebo effect
Arm Type
Placebo Comparator
Arm Description
Intervention: 'Transcranial Direct Current Stimulation - tDCS The patients will receive tDCS stimulation treatment prefrontal cortex dorso lateral According to 10-20 EEG system, anode will be placed at left F3 and cathode at contralateral F4. Placebo stimulation uses a 2 milliamperes current during in the first minutes, in the 10 min and in 19 minutes.
Arm Title
No respondres placebo effect
Arm Type
Active Comparator
Arm Description
Intervention: 'Transcranial Direct Current Stimulation - tDCS The patients will receive tDCS stimulation treatment prefrontal cortex dorso lateral According to 10-20 EEG system, anode will be placed at left F3 and cathode at contralateral F4. Active stimulation uses a 2 milliamperes current during 20 minutes.
Intervention Type
Device
Intervention Name(s)
s-tDCS
Intervention Description
- Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it
Intervention Type
Device
Intervention Name(s)
a- tDCS
Intervention Description
- Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it
Primary Outcome Measure Information:
Title
1.Change in pain level - first phase
Description
Change from before and after the First phase of treatment on Pain scores assessed by a Numerical Pain Scale (NPS 0 to 10) (0 means no pain - 10 means the worst pain imaginable)
Time Frame
Time Frame: 1 month
Title
Change in functional capacity - first phase
Description
The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Change in pain level - second phase
Description
Change from before and after the Second phase of treatment 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
3 months
Title
Change in functional capacity - second phase
Description
Change from before and after the First phase of treatment on Total score on the Brazilian Profile of Chronic Pain: Screen (BPCP:S) (range from 0 to 93; high numbers means more pain severity, interference in daily activities and emotional burden)
Time Frame
3 months
Title
Change in Function of modulatory descending system
Description
Change from before and after the First phase of treatment on the score in a numerical pain scale (NPS 0-10) for a moderate heat pain stimulus to the right arm (ventral region) during a conditioned pain modulation task (CPM-task), where participant keeps the counter-lateral hand in an iced cold water (0 to 1º Celsius)
Time Frame
1 month
Title
Change in Function of corticospinal pathway
Description
Change from before and after the First phase of treatment on measures of motor threshold (MT), motor evoked potential (MEP), intracortical facilitation (ICF), short intracortical inhibition (SICI), and cortical silent period (CSP) assessed with transcranial magnetic stimulation (TMS).
Time Frame
Time Frame: 1 month
Title
7. Change in levels of Brain derived neurotrophic factor - BDNF
Description
Blood samples will be collected at baseline and after the First phase of intervention in order to determine BDNF serum levels using a standardized kit
Time Frame
Time Frame: 1 month

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: Women aged 18 to 65 years; who can read and write, with a confirmed diagnosis of FM according to the American College of Rheumatology criteria (2010-2016). Pain score equal to or greater than six on the Numerical Pain Scale (NPS 0-10) on most days of the last 3 months. Exclusion Criteria: Residing outside the greater Porto Alegre area and pregnancy. Contraindications to TMS and tDCS: metallic implant in the brain; medical devices implanted in the brain, cardiac pacemakers; 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.
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

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21878603
Citation
Clauw DJ, Arnold LM, McCarberg BH; FibroCollaborative. The science of fibromyalgia. Mayo Clin Proc. 2011 Sep;86(9):907-11. doi: 10.4065/mcp.2011.0206.
Results Reference
background
PubMed Identifier
22031874
Citation
Keeser D, Meindl T, Bor J, Palm U, Pogarell O, Mulert C, Brunelin J, Moller HJ, Reiser M, Padberg F. Prefrontal transcranial direct current stimulation changes connectivity of resting-state networks during fMRI. J Neurosci. 2011 Oct 26;31(43):15284-93. doi: 10.1523/JNEUROSCI.0542-11.2011.
Results Reference
background
PubMed Identifier
25005881
Citation
Zanette SA, Dussan-Sarria JA, Souza A, Deitos A, Torres IL, Caumo W. Higher serum S100B and BDNF levels are correlated with a lower pressure-pain threshold in fibromyalgia. Mol Pain. 2014 Jul 8;10:46. doi: 10.1186/1744-8069-10-46.
Results Reference
background

Learn more about this trial

Impact of Susceptibility to Placebo on the Effect of Transcranial Direct Current Stimulation (tDCS) in Fibromyalgia

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