FibromyalgiaFIBROTECNCT05845528
Impact of Susceptibility to Placebo on the Effect of Transcranial Direct Current Stimulation (tDCS) in Fibromyalgia
A study testing s-tDCS and a- tDCS in people with Fibromyalgia, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- s-tDCS and a- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Sep 2021to 20 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90.450-120
About this study
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
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- s-tDCS, a- tDCS
- Keywords
- Fibromyalgia, tDCS, placebo effect, pain, b-endorphin
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
s-tDCSDevice
- Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it
a- tDCSDevice
- Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it
| Study group | Role | What they receive |
|---|---|---|
| Respondres placebo effect | Placebo comparator | 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. Receives: Device: s-tDCS; Device: a- tDCS |
| No respondres placebo effect | Active comparator | 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. Receives: Device: s-tDCS; Device: a- tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Time Frame: 1 month
Change in functional capacity - first phase
The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning
Measured: 1 month
Secondary outcomes (5)
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)
Measured: 3 months
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)
Measured: 3 months
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)
Measured: 1 month
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).
Measured: Time Frame: 1 month
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
Measured: Time Frame: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start16 Sep 2021
- Primary completion25 Apr 2023
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Model description
- Double-Blind, Randomized, Parallel Group, Sham-Controlled Clinical Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
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
- NCT05845528
- Sponsor's protocol ID
- 20200383
- Acronym
- FIBROTEC
- Status last verified
- Jan 2026
- First submitted
- 26 Apr 2023
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21878603Keeser 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.
PubMed 22031874Zanette 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.
PubMed 25005881Caumo W, Franca BR, Orzechowski R, Bueno G, Franca de Souza A, Dos Santos da Silva JV, Sanches PRS, Da Silva DP Jr, Torres ILS, Hirakata VN, Pacheco-Barrios K, Fregni F. Home-Based Transcranial Direct Current Stimulation vs Placebo for Fibromyalgia: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2514262. doi: 10.1001/jamanetworkopen.2025.14262.
PubMed 40478572
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05845528
- Acronym / sponsor ID
- FIBROTEC / 20200383
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, tDCS, placebo effect, pain, b-endorphin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 6 May 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 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-Blind, Randomized, Parallel Group, Sham-Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Respondres placebo effect | Placebo comparator | Device: s-tDCS, Device: a- tDCSIntervention: '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. |
| No respondres placebo effect | Active comparator | Device: s-tDCS, Device: a- tDCSIntervention: '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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| s-tDCS- Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it | Device | No respondres placebo effect, Respondres placebo effect |
| a- tDCS- Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it | Device | No respondres placebo effect, Respondres placebo effect |
Primary outcome
1.Change in pain level - first phase
Time frame: Time Frame: 1 month
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
Time frame: 1 month
The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning
5 secondary outcomes
Change in pain level - second phase
Time frame: 3 months
Change in functional capacity - second phase
Time frame: 3 months
Change in Function of modulatory descending system
Time frame: 1 month
Change in Function of corticospinal pathway
Time frame: Time Frame: 1 month
7. Change in levels of Brain derived neurotrophic factor - BDNF
Time frame: Time Frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Background: PubMed 21878603Clauw 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.
- Background: PubMed 22031874Keeser 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.
- Background: PubMed 25005881Zanette 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.
- Derived from this study: PubMed 40478572Caumo W, Franca BR, Orzechowski R, Bueno G, Franca de Souza A, Dos Santos da Silva JV, Sanches PRS, Da Silva DP Jr, Torres ILS, Hirakata VN, Pacheco-Barrios K, Fregni F. Home-Based Transcranial Direct Current Stimulation vs Placebo for Fibromyalgia: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2514262. doi: 10.1001/jamanetworkopen.2025.14262.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing s-tDCS and a- tDCS in people with Fibromyalgia, run by Hospital de Clinicas de Porto Alegre at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 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 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
1.Change in pain level - first phase (time frame: Time Frame: 1 month). 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 NCT05845528, which also lists 4 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 8 Jan 2026.