FibromyalgiaHFTDCSNCT04890964
Montage of HTDCS in Psycho-cognitive Functions in FM
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Fibromyalgia, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
This study aims to map the impact of anodic transcranial direct current stimulation (tDCS) for prolonged home use applied to the primary motor cortex and the left dorsolateral prefrontal córtex (DLPFC), compared to the respective treatments simulated in fibromyalgia. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2021to 10 Dec 2022
- 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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 30 to 65 years; who can read and write, with a confirmed diagnosis of FM according to the criteria of the American College of Rheumatology (2010-2016). Pain score equal to or greater than six on the Numeric Pain Scale (NPS 0-10) on most days in the last 3 months.
Who cannot join
- Living outside Porto Alegre area and pregnancy.
- Contraindications to TMS and tDCS: metallic implant in the brain; medical devices implanted in the brain, cardiac pacemaker; aneurysmal clip; metallic cochlear prosthesis, ear implants, and non-removable hearing aids; infusion pumps (including implantable); cranial halos. Pregnant women, shift work, use of exogenous melatonin, history of alcohol or drug abuse in the last 6 months, neurological pathologies, history of head trauma or neurosurgery, decompensated systemic chronic diseases, chronic inflammatory diseases (lupus, rheumatoid arthritis, Reiter's syndrome), personal history of cancer, past or under treatment.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90.450-120
Wolnei Caumo, PhD, +5551 3359 6377, wcaumo@hcpa.edu.br
Wolnei Caumo, PhD
About this study
Official title: Mapping the Impact of the Montage of the Transcranial Direct Current Stimulation at Home at Cortical and Psycho-cognitive Functions, Functional Capacity and Biological Rhythm in the Fibromyalgia: A Randomized, Factorial, Clinical Trial
This study aims to map the impact of anodic transcranial direct current stimulation (tDCS) for prolonged home use applied to the primary motor cortex and the left dorsolateral prefrontal córtex (DLPFC), compared to the respective treatments simulated in fibromyalgia.
Read the detailed description
This study aims to map the impact of anodic tDCS for prolonged home use applied to the primary motor cortex and the left dorsolateral prefrontal córtex (DLPFC), compared to the respective treatments simulated in fibromyalgia, targeting the outcomes of the following axes: (1) pain intensity and functional capacity; (2) psycho cognitive functions; (3) neurophysiological markers; (4) biological rhythm markers; (5) to map the potential of neurophysiological markers, biological rhythm and history of trauma in childhood and adolescence in functional capacity, depressive symptoms and working memory tests.
- Conditions
- Fibromyalgia
- Being tested
- Transcranial Direct Current Stimulation (tDCS)
- Keywords
- fibromyalgia, chronic pain, tDCS, TMS, BDNF, cortical connectivity
- 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.
Transcranial Direct Current Stimulation (tDCS)Device
Also called tDCS, Non Invasive Brain Stimulation (NIBS)
A stimulation device, that releases 2.0mA current by a 35 cm2 electrode direct located on a specific location on the scalp for 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS), Active Stimulation - DLPFC | Active comparator | Participants received Active stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
| Transcranial Direct Current Stimulation (tDCS), Sham Stimulation - DLPFC | Sham comparator | Participants received Sham stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
| Transcranial Direct Current Stimulation (tDCS), Active Stimulation - M1 | Active comparator | Participants received Active stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
| Transcranial Direct Current Stimulation (tDCS), Sham Stimulation - M1 | Placebo comparator | Participants received Sham stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of pain
response on the Numeric Verbal Scale (NPS) from 0-10 during the conditioning stimulus
Measured: Up to 60 minutes before and after tDCS stimulation
Secondary outcomes (3)
Psychocognitive functions
episodic memory measured by Rey Verbal test
Measured: Pre and Pos 20 days Intervention
circadian rhythmicity
urinary 6-sulfatoxymelatonin levels
Measured: Pre and Pos 20 days Intervention
Effect of tDCS over DLPFC on cognitive function.
Cortical connectivity
Measured: Pre and Pos 20 days Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start1 Feb 2021
- Primary completion10 Dec 2021 (estimated)
- Study completion10 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- HB-a-tDCS - M1 (n=33); HB-s-tDCS - M1 (n=17); HB-a-tDCS-DLPFC (n=33); HB-a-tDCS- DLPFC (n=17)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 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, Dr, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890964
- Sponsor's protocol ID
- 36995020.3.0000.5327
- Acronym
- HFTDCS
- Status last verified
- May 2021
- First submitted
- 24 Feb 2021
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping the Impact of the Montage of the Transcranial Direct Current Stimulation at Home at Cortical and Psycho-cognitive Functions, Functional Capacity and Biological Rhythm in the Fibromyalgia: A Randomized, Factorial, Clinical Trial
- ClinicalTrials.gov ID
- NCT04890964
- Acronym / sponsor ID
- HFTDCS / 36995020.3.0000.5327
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, chronic pain, tDCS, TMS, BDNF, cortical connectivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 10 Dec 2021 (estimated)
- Study completion
- 10 Dec 2022 (estimated)
- First posted
- 18 May 2021 (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.
This study aims to map the impact of anodic transcranial direct current stimulation (tDCS) for prolonged home use applied to the primary motor cortex and the left dorsolateral prefrontal córtex (DLPFC), compared to the respective treatments simulated in fibromyalgia.
Detailed description
This study aims to map the impact of anodic tDCS for prolonged home use applied to the primary motor cortex and the left dorsolateral prefrontal córtex (DLPFC), compared to the respective treatments simulated in fibromyalgia, targeting the outcomes of the following axes: (1) pain intensity and functional capacity; (2) psycho cognitive functions; (3) neurophysiological markers; (4) biological rhythm markers; (5) to map the potential of neurophysiological markers, biological rhythm and history of trauma in childhood and adolescence in functional capacity, depressive symptoms and working memory tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- HB-a-tDCS - M1 (n=33); HB-s-tDCS - M1 (n=17); HB-a-tDCS-DLPFC (n=33); HB-a-tDCS- DLPFC (n=17)
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS), Active Stimulation - DLPFC | Active comparator | Device: Transcranial Direct Current Stimulation (tDCS)Participants received Active stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days. |
| Transcranial Direct Current Stimulation (tDCS), Sham Stimulation - DLPFC | Sham comparator | Device: Transcranial Direct Current Stimulation (tDCS)Participants received Sham stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days. |
| Transcranial Direct Current Stimulation (tDCS), Active Stimulation - M1 | Active comparator | Device: Transcranial Direct Current Stimulation (tDCS)Participants received Active stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days. |
| Transcranial Direct Current Stimulation (tDCS), Sham Stimulation - M1 | Placebo comparator | Device: Transcranial Direct Current Stimulation (tDCS)Participants received Sham stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women aged 30 to 65 years; who can read and write, with a confirmed diagnosis of FM according to the criteria of the American College of Rheumatology (2010-2016). Pain score equal to or greater than six on the Numeric Pain Scale (NPS 0-10) on most days in the last 3 months.
Key exclusion criteria (2 listed)
- Living outside Porto Alegre area and pregnancy.
- Contraindications to TMS and tDCS: metallic implant in the brain; medical devices implanted in the brain, cardiac pacemaker; aneurysmal clip; metallic cochlear prosthesis, ear implants, and non-removable hearing aids; infusion pumps (including implantable); cranial halos. Pregnant women, shift work, use of exogenous melatonin, history of alcohol or drug abuse in the last 6 months, neurological pathologies, history of head trauma or neurosurgery, decompensated systemic chronic diseases, chronic inflammatory diseases (lupus, rheumatoid arthritis, Reiter's syndrome), personal history of cancer, past or under 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 |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)Also: tDCS, Non Invasive Brain Stimulation (NIBS)A stimulation device, that releases 2.0mA current by a 35 cm2 electrode direct located on a specific location on the scalp for 20 minutes | Device | Transcranial Direct Current Stimulation (tDCS), Active Stimulation - DLPFC, Transcranial Direct Current Stimulation (tDCS), Active Stimulation - M1, Transcranial Direct Current Stimulation (tDCS), Sham Stimulation - DLPFC, Transcranial Direct Current Stimulation (tDCS), Sham Stimulation - M1 |
Primary outcome
level of pain
Time frame: Up to 60 minutes before and after tDCS stimulation
response on the Numeric Verbal Scale (NPS) from 0-10 during the conditioning stimulus
3 secondary outcomes
Psychocognitive functions
Time frame: Pre and Pos 20 days Intervention
circadian rhythmicity
Time frame: Pre and Pos 20 days Intervention
Effect of tDCS over DLPFC on cognitive function.
Time frame: Pre and Pos 20 days Intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
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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, Dr principal investigator
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 Transcranial Direct Current Stimulation (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 2 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: status not confirmed, as of the sponsor's last update on 18 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wolnei Caumo, Dr. (+555199813977, wcaumo@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of pain (time frame: Up to 60 minutes before and after tDCS stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2021.