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Effect of Transcranial Direct-current Stimulation in Eating Behavior of Women With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT04192058
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Food Addiction Device: Sham transcranial direct current stimulation (tDCS) Device: Active transcranial direct current stimulation (tDCS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Transcranial Direct-current Stimulation in Homeostastic and Hedonistic Mechanisms of Eating Behavior in Women With Fibromyalgia
Actual Study Start Date : September 15, 2019
Estimated Primary Completion Date : November 15, 2020
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Sham Comparator: sham 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 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.

Experimental: active 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.
Device: 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.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. weight [ Time Frame: up to 2 weeks ]
    measured by scale

  2. waist circumference. [ Time Frame: up to 2 weeks ]
    measured by measuring tape

  3. State and Trait Food-Cravings Questionnaires (FCQ-s e FCQ-t) [ Time Frame: 6 mouths ]

    - 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.


  4. Hunger and satiety diary [ Time Frame: up to 24 hours ]
    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.

  5. Appetite Diary [ Time Frame: up to 24 hours ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04192058


Locations
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Brazil
Hospital de Clinicas de Porto Alegre Active, not recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90.450-120
Wolnei Caumo Recruiting
Porto Alegre, Brazil
Contact: Wolnei Caumo    55 51 33598001    wolneicaumo@hcpa.com.br   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Wolnei Caumo, Md PhD Hospital de Clinicas de Porto Alegre
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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT04192058    
Other Study ID Numbers: 2019-0237
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital de Clinicas de Porto Alegre:
polymorphism Taq1A
tDCS
dopamine
eating behavior
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Food Addiction
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Feeding and Eating Disorders
Mental Disorders