FibromyalgiaNeuroFibroNCT03384888
Neurostimulation Applied to Fibromyalgia
A study testing Active tDCS in people with Fibromyalgia, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
NeuroFibro is a double-blind, randomized, placebo-controlled clinical trial, using neurostimulation in women with fibromyalgia. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteBrazil
- Study dates
- 15 May 2017to May 2020
- 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 25 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- (1) diagnosis of fibromyalgia, according to the American College of Rheumatology criteria;
- (2) been diagnosed for at least three months;
- (3) be female;
- (4) be in the age group between 25 and 60 years of age; and
- (5) sign the consent form.
Who cannot join
- (1) cognitive deficit, evaluated through the Mini Mental State Examination (MMSE);
- (2) illiterate;
- (3) people with metallic implants located on the head, cochlear implants and cardiac pacemaker;
- (4) history of convulsion;
- (5) severe depression, measured by score greater than 36 on Beck Depression Inventory; and
- (6) be pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
NeuroFibro is a double-blind, randomized, placebo-controlled clinical trial, using neurostimulation in women with fibromyalgia.
- Conditions
- Fibromyalgia
- Being tested
- Active tDCS, Sham tDCS
- Keywords
- Fibromyalgia, Neurostimulation, TDCS
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
Also called Transcranial direct current stimulation
Transcranial direct current stimulation Duration: 20 minutes; Intensity: 2 mA (miliamps); Placement of the electrodes: anode over the left M1 and cathode region over the right supraorbital region.
Sham tDCSDevice
Also called Transcranial direct current stimulation
Sham Transcranial direct current stimulation The procedure is the same as for active tDCS, but the stimulation is non-active / sham.
| Study group | Role | What they receive |
|---|---|---|
| ano-M1-cat-SO5 tDCS | Experimental | Participants will receive active transcranial direct current stimulation (tDCS) (active tDCS). The electrodes will be placed on left M1 for anodic stimulation and on the right supraorbital region for cathodic stimulation on 5 consecutive days. Receives: Device: Active tDCS |
| ano-M1-cat-SO10 tDCS | Experimental | Participants will receive active transcranial direct current stimulation (active tDCS). The electrodes will be placed on left M1 for anodic stimulation and on the right supraorbital region for cathodic stimulation on 10 consecutive days. Receives: Device: Active tDCS |
| Sham tDCS | Sham comparator | Participants who receive stimulation of the simulated type (sham tDCS), following the protocol of the ano-M1-cat-SO5 group. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity level
Changes in pain level, assessed by the Visual Analog Scale, ranges from 0 - 10, with 10 being the highest level of pain.
Measured: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Secondary outcomes (8)
Quality of life level
Changes in quality of life level assessed by Fibromyalgia Impact Questionnaire (FIQ). The FIQ is composed of 19 questions, which measure functional capacity, work status, psychological disturbances, physical and painful symptoms. The greater the impact of the disease, the greater the score found. The FIQ consists of 10 items. The first item contains 10 questions ("a" through "j") related to physical functioning - each issue is evaluated on a four-point Likert scale. In items 2 and 3, the patient is asked to mark the number of days he felt well and the number of days that were unable to work (including housework) because of fibromyalgia-related symptoms. Items 4 to 10 are horizontal lines of 10 cm in length (Visual Analog Scale), in which the patient measures the difficulty for work, pain, fatigue, morning tiredness, stiffness, anxiety and depression.
Measured: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Health assessment level
Changes in health assessed level assessed by Fibromyalgia Health Assessment (HAQ). It has eight categories: clothing and physical presence, wake up, feed, walk, hygiene, reach, footprint and other daily activities. For each of these categories, the patient indicates the degree of difficulty in four possible responses ranging from "no difficulty = 0" to "unable to do it = 3". The score for each category appears in the highest number of any of your items. The final HAQ score is the average of the scores of the eight categories and the higher the final score the worse the test result. Questionaire.
Measured: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Sleep quality
Changes in sleep quality assessed by Pittsburgh Sleep Quality Index.
Measured: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Cognitive function
Changes in the cognitive function assessed by Mini Mental State Examination.
Measured: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Anxiety level
Changes in the anxiety level assessed by Beck Anxiety Inventory
Measured: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Depression level
Changes in the depression level assessed by Beck Depression Inventory
Measured: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Cortical electrical activity
Changes in the cortical electrical activity assessed by electroencephalogram
Measured: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Resilience
Changes in the resilience assessed by Wagnild and Young Resilience Scale. It has 25 items described positively with likert type response ranging from 1 (totally disagree) to 7 (totally agree). Scale scores range from 25 to 175 points, with high values indicating high resilience.
Measured: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start15 May 2017
- Primary completionMay 2019 (estimated)
- Study completionMay 2020 (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.
- 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
- The parallel clinical trial simultaneously compares two groups of individuals, one of which receives the intervention of interest and the other is a control group (sham).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Géssika Araújo de Melo, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384888
- Sponsor's protocol ID
- Eliane Araújo de Oliveira
- Acronym
- NeuroFibro
- Status last verified
- Jan 2019
- First submitted
- 20 Dec 2017
- Last updated
- 23 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurostimulation Applied to Fibromyalgia
- ClinicalTrials.gov ID
- NCT03384888
- Acronym / sponsor ID
- NeuroFibro / Eliane Araújo de Oliveira
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Neurostimulation, TDCS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 28 Dec 2017 (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.
NeuroFibro is a double-blind, randomized, placebo-controlled clinical trial, using neurostimulation in women with fibromyalgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- The parallel clinical trial simultaneously compares two groups of individuals, one of which receives the intervention of interest and the other is a control group (sham).
| Arm | Type | Receives |
|---|---|---|
| ano-M1-cat-SO5 tDCS | Experimental | Device: Active tDCSParticipants will receive active transcranial direct current stimulation (tDCS) (active tDCS). The electrodes will be placed on left M1 for anodic stimulation and on the right supraorbital region for cathodic stimulation on 5 consecutive days. |
| ano-M1-cat-SO10 tDCS | Experimental | Device: Active tDCSParticipants will receive active transcranial direct current stimulation (active tDCS). The electrodes will be placed on left M1 for anodic stimulation and on the right supraorbital region for cathodic stimulation on 10 consecutive days. |
| Sham tDCS | Sham comparator | Device: Sham tDCSParticipants who receive stimulation of the simulated type (sham tDCS), following the protocol of the ano-M1-cat-SO5 group. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- (1) diagnosis of fibromyalgia, according to the American College of Rheumatology criteria;
- (2) been diagnosed for at least three months;
- (3) be female;
- (4) be in the age group between 25 and 60 years of age; and
- (5) sign the consent form.
Key exclusion criteria (6 listed)
- (1) cognitive deficit, evaluated through the Mini Mental State Examination (MMSE);
- (2) illiterate;
- (3) people with metallic implants located on the head, cochlear implants and cardiac pacemaker;
- (4) history of convulsion;
- (5) severe depression, measured by score greater than 36 on Beck Depression Inventory; and
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 |
|---|---|---|
| Active tDCSAlso: Transcranial direct current stimulationTranscranial direct current stimulation Duration: 20 minutes; Intensity: 2 mA (miliamps); Placement of the electrodes: anode over the left M1 and cathode region over the right supraorbital region. | Device | ano-M1-cat-SO10 tDCS, ano-M1-cat-SO5 tDCS |
| Sham tDCSAlso: Transcranial direct current stimulationSham Transcranial direct current stimulation The procedure is the same as for active tDCS, but the stimulation is non-active / sham. | Device | Sham tDCS |
Primary outcome
Pain intensity level
Time frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Changes in pain level, assessed by the Visual Analog Scale, ranges from 0 - 10, with 10 being the highest level of pain.
8 secondary outcomes
Quality of life level
Time frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Health assessment level
Time frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Sleep quality
Time frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Cognitive function
Time frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Anxiety level
Time frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Depression level
Time frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Cortical electrical activity
Time frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Resilience
Time frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS in people with Fibromyalgia, run by Federal University of Paraíba 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 5 inclusion and 6 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 23 Jan 2019. 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?
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?
Pain intensity level (time frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)). 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 23 Jan 2019.