FibromyalgiaNCT04192058
Effect of Transcranial Direct-current Stimulation in Eating Behavior of Women With Fibromyalgia
A study testing Active transcranial direct current stimulation (tDCS) in people with Fibromyalgia and Food Addiction, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
Trial summary
Introduction: Fibromyalgia (FM) is a syndrome characterized by generalized musculoskeletal pain, fatigue, non-repairing sleep, cognitive changes, depressive symptoms and other correlates of autonomic dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia, Food Addiction
- What is being tested?
- Active 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
- 60 participants
- Where
- 2 sitesBrazil
- Study dates
- 15 Sep 2019to 15 Dec 2021
- 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
- Right-handers who can read and write,
- Confirmed diagnosis of FM
- Pain score of six or more on the Numerical Pain Scale (SPN 0-10) on most days of the last 3 months.
Who cannot join
- Living outside the Greater Porto Alegre area and pregnancy. Contraindications to EMT and ETCC: metallic implant in the brain; medical devices implanted in the brain, cardiac pacemaker; cochlear implant; history of alcohol or drug abuse in the last 6 months; neurological disorders; hx of head trauma or neurosurgery; decompensated systemic diseases, and chronic inflammatory diseases (lupus, rheumatoid arthritis, Sjogren's syndrome, Reiter's syndrome); uncompensated hypothyroidism; personal history of cancer, past or under treatment. Weight loss use and bariatric surgery.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 1 recruiting
- Active, not recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90.450-120
- Recruiting
Wolnei Caumo
Porto Alegre
Wolnei Caumo, 55 51 33598001, wolneicaumo@hcpa.com.br
About this study
Official title: Effect of Transcranial Direct-current Stimulation in Homeostastic and Hedonistic Mechanisms of Eating Behavior in Women With Fibromyalgia
Introduction: Fibromyalgia (FM) is a syndrome characterized by generalized musculoskeletal pain, fatigue, non-repairing sleep, cognitive changes, depressive symptoms and other correlates of autonomic dysfunction. A high prevalence of overweight in patients with fibromyalgia is observed, about 80% according to current data, which affects the course and prognosis of the disease, besides overburdening health costs and further compromising quality of life. life of these patients. Evidence shows possible pathophysiological pathways shared by these two pathologies, as well as aspects related to food behavior. It is known that dopaminergic neurotransmission is altered in both, suggesting an increase in the sensitivity or density of D2 dopamine receptors. Non-pharmacological options for pain management and dysfunctional eating behavior include the important contribution of neuromodulatory techniques of non-invasive cerebral stimulation, such as transcranial direct current stimulation (tDCS), which aims to increase resisting hyperpalatable foods and reducing caloric intake. Objectives: To evaluate the association between dopamine receptor-2 (DRD2) Taq1A allele A1 polymorphism (rs1800497) and to observe the possible effect of tDCS on the dorsolateral prefrontal cortex (DLPFC) on homeostatic and hedonistic aspects of eating behavior in women with FM. Methods: A randomized, double blind, parallel group, controlled trial with simulated treatment will be performed. Will be included in the study women literate, right-handed, with confirmed diagnosis of FM. The evaluation will be done through questionnaires on pain and eating behavior, anthropometric evaluation and biochemical measurements. The intervention will take place through active or simulated home for 4 weeks. Perspectives: To evaluate dysfunctional neuroplastic changes in eating behavior and biological markers and also to serve as a basis for future effective treatment strategies through neuromodulation and nutritional counseling.
Read the detailed description
A randomized, double-blind, parallel-group controlled trial with sham treatment will be conducted in fibromyalgia patients to assess aspects of eating behavior.
- Conditions
- Fibromyalgia, Food Addiction
- Being tested
- Sham transcranial direct current stimulation (tDCS), Active transcranial direct current stimulation (tDCS)
- Keywords
- polymorphism Taq1A, tDCS, dopamine, eating behavior
- Medical subject headings
- Fibromyalgia, Food Addiction, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham transcranial direct current stimulation (tDCS)Device
For sham treatment we will use the same assembly as the active ETCC. However, we will apply the current for 30s at the start of the stimulation session and 30s at the end of the session.
Active transcranial direct current stimulation (tDCS)Device
Transcranial direct current stimulation (tDCS) it is a therapeutic method that modulates membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it. The position of the electrodes will be performed based on a 10-20 system according to the international EEG unit system, with the location of the electrodes at C3 and F3, respectively. The anode will be positioned over the left hemisphere at C3 while the cathode will be positioned over the contralateral hemisphere F3. During active stimulation a 2.0mA current released by a 35 cm2 electrode will be used for 20 min.
| Study group | Role | What they receive |
|---|---|---|
| sham tDCS | Sham comparator | For sham treatment we will use the same assembly as the active ETCC. However, we will apply the current for 30s at the start of the stimulation session and 30s at the end of the session. Receives: Device: Sham transcranial direct current stimulation (tDCS) |
| active tDCS | Experimental | The anode will be positioned over the left hemisphere at C3 while the cathode will be positioned over the contralateral hemisphere F3. During active stimulation a 2.0mA current released by a 35 cm2 electrode will be used for 20 min. The position of the electrodes will be performed based on a 10-20 system according to the international EEG unit system, with the location of the electrodes at C3 and F3, respectively. Receives: Device: Active transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three Factor Eating Questionnaire 21
TFE-Q was developed by Stunkard and Messic (1985) to access three dimensions of human eating behavior: Cognitive Restriction (CR), Eating Disorder (AD) and Emotional Eating (AE). Originally made up of 51 items and reduced in the TFEQ-18, TFEQ-18, TFEQ-21 versions. We will use the TFEQ-21. The average obtained from the sum of the questions for each domain was converted to a scale ranging from 0 to 100.
Evaluates dysfunctional eating behavior. Cognitive restriction: limitation of food intake for weight control; Uncontrolled Food: Tendency to lose control over eating from hunger or when exposed to external environments, even in the absence of physiological hunger; Emotional Eating: Susceptible to eating in response to emotional stress or negative mood.
Measured: 6 mouths
Secondary outcomes (5)
weight
measured by scale
Measured: up to 2 weeks
waist circumference.
measured by measuring tape
Measured: up to 2 weeks
State and Trait Food-Cravings Questionnaires (FCQ-s e FCQ-t)
- FCQ-T consists of 39 statements and was developed to access food cravings aspects over time and in various situations, considering them as a (usual) trait behavior of the respondent.
Higher scores in this questionnaire are related to a more exaggerated eating.
- FCQ-S is composed of 15 statements and is a tool sensitive to changes in contextual, psychological and physiological states in response to specific situations (such as stressful events or food deprivation), considering the food craving as a (sporadic) state behavior of the respondent.
Higher scores in this questionnaire are associated with greater food deprivation, negative eating-related experiences and a greater susceptibility to triggers that lead to eating.
Totals of both tools for the full subscales and their dimensions are calculated by adding the corresponding scores of each statement.
Measured: 6 mouths
Hunger and satiety diary
Hunger and satiety measured by the 100 mm Analog-Visual Scale (VAS), whose zero corresponds to the absence of hunger or appetite and 100 mm hunger or maximum appetite. Patients should report hunger, hunger or satiety for most of the last 24 hours.
Measured: up to 24 hours
Appetite Diary
Appetite measured by means of the 100 mm Analog-Visual Scale (VAS), whose zero corresponds to the absence of appetite and 100 mm or maximum appetite. Patients should report nonspecific appetite for sweet or salty most of the last 24 hours.
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start15 Sep 2019
- Primary completion15 Nov 2020 (estimated)
- Study completion15 Dec 2021 (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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 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, Md PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192058
- Sponsor's protocol ID
- 2019-0237
- Status last verified
- Jan 2020
- First submitted
- 31 Oct 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Direct-current Stimulation in Homeostastic and Hedonistic Mechanisms of Eating Behavior in Women With Fibromyalgia
- ClinicalTrials.gov ID
- NCT04192058
- Acronym / sponsor ID
- 2019-0237
- Conditions
- Fibromyalgia, Food Addiction
- Keywords
- polymorphism Taq1A, tDCS, dopamine, eating behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 15 Nov 2020 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 10 Dec 2019 (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.
Introduction: Fibromyalgia (FM) is a syndrome characterized by generalized musculoskeletal pain, fatigue, non-repairing sleep, cognitive changes, depressive symptoms and other correlates of autonomic dysfunction. A high prevalence of overweight in patients with fibromyalgia is observed, about 80% according to current data, which affects the course and prognosis of the disease, besides overburdening health costs and further compromising quality of life. life of these patients. Evidence shows possible pathophysiological pathways shared by these two pathologies, as well as aspects related to food behavior. It is known that dopaminergic neurotransmission is altered in both, suggesting an increase in the sensitivity or density of D2 dopamine receptors. Non-pharmacological options for pain management and dysfunctional eating behavior include the important contribution of neuromodulatory techniques of non-invasive cerebral stimulation, such as transcranial direct current stimulation (tDCS), which aims to increase resisting hyperpalatable foods and reducing caloric intake. Objectives: To evaluate the association between dopamine receptor-2 (DRD2) Taq1A allele A1 polymorphism (rs1800497) and to observe the possible effect of tDCS on the dorsolateral prefrontal cortex (DLPFC) on homeostatic and hedonistic aspects of eating behavior in women with FM. Methods: A randomized, double blind, parallel group, controlled trial with simulated treatment will be performed. Will be included in the study women literate, right-handed, with confirmed diagnosis of FM. The evaluation will be done through questionnaires on pain and eating behavior, anthropometric evaluation and biochemical measurements. The intervention will take place through active or simulated home for 4 weeks. Perspectives: To evaluate dysfunctional neuroplastic changes in eating behavior and biological markers and also to serve as a basis for future effective treatment strategies through neuromodulation and nutritional counseling.
Detailed description
A randomized, double-blind, parallel-group controlled trial with sham treatment will be conducted in fibromyalgia patients to assess aspects of eating behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham tDCS | Sham comparator | Device: Sham transcranial direct current stimulation (tDCS)For sham treatment we will use the same assembly as the active ETCC. However, we will apply the current for 30s at the start of the stimulation session and 30s at the end of the session. |
| active tDCS | Experimental | Device: Active transcranial direct current stimulation (tDCS)The anode will be positioned over the left hemisphere at C3 while the cathode will be positioned over the contralateral hemisphere F3. During active stimulation a 2.0mA current released by a 35 cm2 electrode will be used for 20 min. The position of the electrodes will be performed based on a 10-20 system according to the international EEG unit system, with the location of the electrodes at C3 and F3, respectively. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Right-handers who can read and write,
- Confirmed diagnosis of FM
- Pain score of six or more on the Numerical Pain Scale (SPN 0-10) on most days of the last 3 months.
Key exclusion criteria (1 listed)
- Living outside the Greater Porto Alegre area and pregnancy. Contraindications to EMT and ETCC: metallic implant in the brain; medical devices implanted in the brain, cardiac pacemaker; cochlear implant; history of alcohol or drug abuse in the last 6 months; neurological disorders; hx of head trauma or neurosurgery; decompensated systemic diseases, and chronic inflammatory diseases (lupus, rheumatoid arthritis, Sjogren's syndrome, Reiter's syndrome); uncompensated hypothyroidism; personal history of cancer, past or under treatment. Weight loss use and bariatric surgery.
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 |
|---|---|---|
| Sham transcranial direct current stimulation (tDCS)For sham treatment we will use the same assembly as the active ETCC. However, we will apply the current for 30s at the start of the stimulation session and 30s at the end of the session. | Device | sham tDCS |
| Active transcranial direct current stimulation (tDCS)Transcranial direct current stimulation (tDCS) it is a therapeutic method that modulates membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it. The position of the electrodes will be performed based on a 10-20 system according to the international EEG unit system, with the location of the electrodes at C3 and F3, respectively. The anode will be positioned over the left hemisphere at C3 while the cathode will be positioned over the contralateral hemisphere F3. During active stimulation a 2.0mA current released by a 35 cm2 electrode will be used for 20 min. | Device | active tDCS |
Primary outcome
Three Factor Eating Questionnaire 21
Time frame: 6 mouths
TFE-Q was developed by Stunkard and Messic (1985) to access three dimensions of human eating behavior: Cognitive Restriction (CR), Eating Disorder (AD) and Emotional Eating (AE). Originally made up of 51 items and reduced in the TFEQ-18, TFEQ-18, TFEQ-21 versions. We will use the TFEQ-21. The average obtained from the sum of the questions for each domain was converted to a scale ranging from 0 to 100. Evaluates dysfunctional eating behavior. Cognitive restriction: limitation of food intake for weight control; Uncontrolled Food: Tendency to lose control over eating from hunger or when exposed to external environments, even in the absence of physiological hunger; Emotional Eating: Susceptible to eating in response to emotional stress or negative mood.
5 secondary outcomes
weight
Time frame: up to 2 weeks
waist circumference.
Time frame: up to 2 weeks
State and Trait Food-Cravings Questionnaires (FCQ-s e FCQ-t)
Time frame: 6 mouths
Hunger and satiety diary
Time frame: up to 24 hours
Appetite Diary
Time frame: up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- 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, Md PhD principal investigator
Hospital de Clinicas de Porto Alegre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active transcranial direct current stimulation (tDCS) in people with Fibromyalgia and Food Addiction, run by Hospital de Clinicas de Porto Alegre at 2 sites 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 3 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: status not confirmed, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three Factor Eating Questionnaire 21 (time frame: 6 mouths). 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 13 Jan 2020.